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Li H, Xiao C, Pan H, Lei Y, Wang H, Li S. Biomechanical study between percutaneous vertebroplasty combined with cement pedicle plasty improves vertebral biomechanical stability: A finite element analysis. BMC Musculoskelet Disord 2024; 25:597. [PMID: 39075431 PMCID: PMC11285430 DOI: 10.1186/s12891-024-07689-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/18/2024] [Accepted: 07/12/2024] [Indexed: 07/31/2024] Open
Abstract
OBJECTIVE To investigate the biomechanical effects of percutaneous vertebroplasty combined with cement pedicle plasty (PVCPP) on the unstable osteoporotic vertebral fractures (OVFs) through finite element (FE) analysis. The study compares the biomechanical stability of finite element models between percutaneous vertebroplasty (PVP) and percutaneous vertebroplasty combined with cement pedicle plasty. METHODS Two patients with unstable OVFs underwent computed tomography (CT) examination at the thoracolumbar vertebral body levels, respectively. The CT images were reconstructed into three-dimensional finite element models to simulate stress conditions across six dimensions and to evaluate the vertebral von Mises stress before and after bone cement reinforcement. RESULTS The study found that stress distribution differed between groups mainly at the pedicle base. In the surgical vertebral bodies, the maximum stress in the PVP group decreased during flexion and left bending, while it increased in other states. In the PVCPP group, all maximum stresses decreased. In the inferior vertebral bodies, the maximum stress in the PVP group generally increased, while it decreased in the PVCPP group. In the superior vertebral bodies, postoperatively, the maximum stress in the PVP group generally increased, while it almost remained unchanged in the PVCPP group. PVP group had higher cement stress and displacement. CONCLUSION PVCPP is an effective treatment method for patients with unstable OVFs. It can quickly relieve pain and enhance the stability of the three columns, thereby reducing the risk of some complications.
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Affiliation(s)
- Hongtao Li
- Department of Spine Surgery, The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou, Sichuan Province, 646000, China
| | - Changming Xiao
- Department of Spine Surgery, The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou, Sichuan Province, 646000, China
| | - Hongyu Pan
- Department of Spine Surgery, The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou, Sichuan Province, 646000, China
| | - Yang Lei
- Department of Spine Surgery, The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou, Sichuan Province, 646000, China
| | - Haozhong Wang
- Department of Spine Surgery, The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou, Sichuan Province, 646000, China
| | - Sen Li
- Division of Spine Surgery, Department of Orthopedic Surgery, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Nanjing, Jiangsu Province, 210000, China.
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Steib JP, Dufour T, Beaurain J, Bernard P, Huppert J. Observational, Multicenter Study of the Efficacy and Safety of Cervical Disk Arthroplasty With Mobi-C in the Treatment of Cervical Degenerative Disk Disease. Results at 10 years Follow-Up. Spine (Phila Pa 1976) 2023; 48:452-459. [PMID: 36730682 DOI: 10.1097/brs.0000000000004536] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2022] [Accepted: 10/04/2022] [Indexed: 02/04/2023]
Abstract
BACKGROUND Cervical disk arthroplasty replacement (CDA) was developed to avoid specific disadvantages of cervical fusion. The purpose of this paper is to provide 10-year follow-up results of an ongoing prospective study after CDA. METHODS Three hundred eighty-four patients treated using the Mobi-C (ZimVie, Troyes, France) were included in a prospective multicenter study. Routine clinical and radiologic examinations were reported preoperatively and postoperatively with up to 10-year follow-up. Complications and revision surgeries were also documented. RESULTS At 10 years showed significant improvement in all clinical outcomes [Neck Disability Index, visual analog scale (VAS) for arm and neck pain, physical component summary of SF36, and mental component summary of SF36). Motion at the index level increased significantly over baseline (mean range of motion=7.6 vs. 8 degrees at five years and 6.0 degrees preoperatively; P <0.001) and 71.3% of the implanted segments remained mobile (range of motion>3 degrees). Adjacent disks were also mobile at 10 years with the same mobility as preoperatively. At 10 years, 20.9% of the implanted segments demonstrated no heterotopic ossification. Thirty-four patients (8.9%) experienced 41 adverse events, with or without reoperation during the first five years. We found only two additional surgeries after five years. We observed an increased percentage of working patients and a decrease in medication consumption. Regarding the overall outcome, 94% of patients were satisfied. CONCLUSIONS Our 10-year results showed significant improvement in all clinical outcomes, with low rates of revision or failure. This experience in patients with long-term follow-up after CDA endorses durable, favorable outcomes in properly selected patients.
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Affiliation(s)
| | - Thierry Dufour
- Parisian Institute, Geoffroy Saint-Hilaire Clinic, Paris, France
| | | | - Pierre Bernard
- Orthopaedic Department, Back Aquitain Center, Mérignac, France
| | - Jean Huppert
- Neuro-Surgery Department, Clinic of Parc, St-Priest-en-Jarez, France
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Finite Element Analysis of Unilateral versus Bipedicular Bone-Filling Mesh Container for the Management of Osteoporotic Compression Fractures. BIOMED RESEARCH INTERNATIONAL 2022; 2022:6850089. [PMID: 35252453 PMCID: PMC8894004 DOI: 10.1155/2022/6850089] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/30/2021] [Revised: 11/29/2021] [Accepted: 01/28/2022] [Indexed: 11/17/2022]
Abstract
The effect of unilateral and bilateral bone-filling mesh containers (BFC) on osteoporotic vertebral compression fracture (OVCF) was analyzed by the finite element method. The CT scan data of the T12-L2 vertebral body were obtained from a healthy female volunteer with no history of lumbar spine injury or obvious abnormality of vertebral body morphology. The normal finite element model of the T12-L2 vertebral body and the finite element model of osteoporosis were established, and the models were validated. The L1 in the normal model of the vertebral body was used to simulate the vertebral compression fracture, after which the unilateral and bilateral BFC were simulated to establish models representing the two surgical approaches. We analyzed changes in the deformation and von Mises stress in vertebral bodies and intervertebral discs in the two models under seven working conditions (axial direction, anteflexion, rear protraction, left-side bending, right-side bending, left rotation, and right rotation) and found that the unilateral and bilateral approaches are biomechanically comparable, with no statistical difference between the two overall models.
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Li N, Cavagnaro MJ, Xiong K, Du X, Shi J. The Multi-Modal Risk Analysis and Medical Prevention of Lumbar Degeneration, Fatigue, and Injury Based on FEM/BMD for Elderly Chinese Women Who Act as Stay-Home Grandchildren Sitters. Front Public Health 2021; 9:700148. [PMID: 34888274 PMCID: PMC8648567 DOI: 10.3389/fpubh.2021.700148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2021] [Accepted: 08/09/2021] [Indexed: 11/17/2022] Open
Abstract
Background: An increasing number of Chinese elderly women stay at home and act as grandchildren sitters. In consequence of the frequent load-bearing, chronic lumbar fatigue probably caused a higher risk of lumbar degeneration, fatigue, and injury which has become one of the most important aging and health problems in China. In this study, a multi-mode lumbar finite element model (FEM) with specific bone mineral density (BMD) were developed and validated for further spine injury prevention and control. Methods: The material properties of lumbar vertebra were modified according to degenerated bone mineral density, and geometry was adjusted based on intervertebral disc height. The motion of lifting children was simulated by a 76 year-old Chinese women's FEM, and the stress distribution was calculated and predicted. Results: The pressure of L5-S intervertebral disc in the bending 3-year-old dummy lifting posture was significantly higher than the same posture without lifting, the maximum effective stress of endplate cartilage in the upright child lifting posture was 1.6 times that of the bending without lifting posture. And the fatigue risk limitation frequency of the upright with dummy posture was predicted with the functional equation of fatigue and stress which was deduced by genetic algorithm, which combined with the effective stress of lumbar vertebrae spongy bone calculated from FEM. Conclusions: The child-lifting motion could increase the risk of lumbar degeneration, fatigue, and injury in elderly women, and they should keep below the frequency limit of the motion of lifting children in their daily life. This study could put forward scientific injury prevention guidance to Chinese elderly women who lift children in daily life frequently.
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Affiliation(s)
- Na Li
- Department of Radiology, The Third Xiangya Hospital, Central South University, Changsha, China
| | - María José Cavagnaro
- College of Medicine-Phoenix, The University of Arizona, Phoenix, AZ, United States
| | - Kun Xiong
- Department of Anatomy and Neurobiology, School of Basic Medical Sciences, Central South University, Changsha, China
| | - Xianping Du
- Department of Mechanical and Aerospace Engineering, Rutgers University, New Brunswick, NJ, United States
| | - Jian Shi
- Department of Spine Surgery, The Third Xiangya Hospital, Central South University, Changsha, China
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Bohn T, Lang SAJ, Roll S, Schrader H, Pumberger M, Büttner-Janz K. Meta-analyses comparing spine simulators with cadavers and finite element models by analysing range-of-motion data before and after lumbar total disc replacement. J Adv Res 2020; 26:29-41. [PMID: 33133681 PMCID: PMC7584673 DOI: 10.1016/j.jare.2020.06.017] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2020] [Revised: 05/19/2020] [Accepted: 06/20/2020] [Indexed: 11/26/2022] Open
Abstract
Data from two different in vitro test methods for the same evaluation subjects were compared. It was investigated whether spine simulators with real human cadavers (SSCs) and finite element models (FEMs) provide the same data exemplarily for range of motion (ROM) before and after insertion of motion-retaining devices. Only fifty-nine percent of SSC meta-analyses show restored ROM after insertion of the device compared to the intact spinal segment. In FEM meta-analyses, ROM is restored in ninety percent. Ten percent of ROM analyses show significantly different data between SSCs and FEMs. With regard to the included studies, data generated by SSCs and FEMs cannot be used unrestricted as alternative and complementary data. Our analysis provides a new approach to compare data from associated test methods. Background Range-of-motion (ROM) data generated by the in vitro test methods of spine simulators with cadavers (SSCs) and finite element models (FEMs) are used alternatively and complementarily for in vitro evaluations. Aim of Review Our purpose is to compare exemplary segmental ROM data from SSCs and FEMs before and after ball-and-socket total disc replacement (bsTDR) to determine whether the two test methods provide the same data for the same evaluation subjects. Key Scientific Concepts of Review We performed 70 meta-analyses (MAs) and 20 additional comparative analyses based on data from 21 SSC studies used for 39 MAs and 16 FEM studies used for 31 MAs. Only fifty-nine percent (n = 23/39) of SSC MAs show a restored ROM after bsTDR, whereas in FEM MAs, the ROM is restored in ninety percent (n = 28/31). Among the analyses comparing data from the same spinal segments, motion directions and bsTDR, SSC and FEM data are significantly different in ten percent (n = 2/20). According to our results, data generated by SSCs and FEMs cannot be used as alternative and complementary data without restriction. The quality of the evaluation methods itself as well as potential technical reasons for the discrepant results were not our evaluation target. Further SSC and FEM data should be compared using the same approach.
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Affiliation(s)
- Tobias Bohn
- Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.,Institute of Radiology, Ortenau Klinikum Offenburg-Kehl, Ebertplatz 12, 77654 Offenburg, Germany
| | - Susanne A J Lang
- Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
| | - Stephanie Roll
- Institute for Social Medicine, Epidemiology and Health Economics at Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
| | - Helene Schrader
- Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
| | - Matthias Pumberger
- Center for Musculoskeletal Surgery at Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
| | - Karin Büttner-Janz
- Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.,Büttner-Janz Spinefoundation, Meinekestraße 6, 10719 Berlin, Germany
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Sandhu FA, Dowlati E, Garica R. Lumbar Arthroplasty: Past, Present, and Future. Neurosurgery 2019; 86:155-169. [DOI: 10.1093/neuros/nyz439] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2019] [Accepted: 07/17/2019] [Indexed: 01/27/2023] Open
Abstract
Abstract
Lumbar degenerative disc disease is a pathologic process that affects a large portion of our aging population. In the recent past, surgical treatment has involved fusion procedures. However, lumbar disc arthroplasty and replacement provides an alternative for carefully selected patients. It provides the major advantage of motion preservation and thus keeps adjacent segments from significantly progressive degeneration. The history of lumbar disc replacement has roots that start in the 1960s with the implantation of stainless-steel balls. Decades later, multiple implants with different material design and biomechanical properties were introduced to the market. New third-generation implants have made great strides in improved biomechanics and clinical outcomes. Although there is room for further advancement and studies are warranted to assess the long-term durability and sustainability of lumbar disc arthroplasty, it has certainly proven to be a very acceptable alternative within the surgical armamentarium that should be offered to patients who meet indications. In this review we present an overview of lumbar disc arthroplasty including its history, indications, biomechanics, challenges, and future directions.
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Affiliation(s)
- Faheem A Sandhu
- Department of Neurosurgery, Medstar Georgetown University Hospital, Washington, District of Columbia
| | - Ehsan Dowlati
- Department of Neurosurgery, Medstar Georgetown University Hospital, Washington, District of Columbia
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Zhao WT, Qin DP, Zhang XG, Wang ZP, Tong Z. Biomechanical effects of different vertebral heights after augmentation of osteoporotic vertebral compression fracture: a three-dimensional finite element analysis. J Orthop Surg Res 2018; 13:32. [PMID: 29422073 PMCID: PMC5806350 DOI: 10.1186/s13018-018-0733-1] [Citation(s) in RCA: 30] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/09/2017] [Accepted: 01/25/2018] [Indexed: 02/07/2023] Open
Abstract
Background Clinical results have shown that different vertebral heights have been restored post-augmentation of osteoporotic vertebral compression fractures (OVCFs) and the treatment results are consistent. However, no significant results regarding biomechanical effects post-augmentation have been found with different types of vertebral deformity or vertebral heights by biomechanical analysis. Therefore, the present study aimed to investigate the biomechanical effects between different vertebral heights of OVCFs before and after augmentation using three-dimensional finite element analysis. Methods Four patients with OVCFs of T12 underwent computed tomography (CT) of the T11-L1 levels. The CT images were reconstructed as simulated three-dimensional finite-element models of the T11-L1 levels (before and after the T12 vertebra was augmented with cement). Four different kinds of vertebral height models included Genant semi-quantitative grades 0, 1, 2, and 3, which simulated unilateral augmentation. These models were assumed to represent vertical compression and flexion, left flexion, and right flexion loads, and the von Mises stresses of the T12 vertebral body were assessed under different vertebral heights before and after bone cement augmentation. Results Data showed that the von Mises stresses significantly increased under four loads of OVCFs of the T12 vertebral body before the operation from grade 0 to grade 3 vertebral heights. The maximum stress of grade 3 vertebral height pre-augmentation was produced at approximately 200%, and at more than 200% for grade 0. The von Mises stresses were significantly different between different vertebral heights preoperatively. The von Mises stresses of the T12 vertebral body significantly decreased in four different loads and at different vertebral body heights (grades 0–3) after augmentation. There was no significant difference between the von Mises stresses of grade 0, 1, and 3 vertebral heights postoperatively. The von Mises stress significantly decreased between pre-augmentation and post-augmentation in T12 OVCF models of grade 0–3 vertebral heights. Conclusion Vertebral augmentation can sufficiently reduce von Mises stresses at different heights of OVCFs of the vertebral body, although this technique does not completely restore vertebral height to the anatomical criteria.
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Affiliation(s)
- Wen-Tao Zhao
- Gansu University of Chinese Medicine, No. 35, Dingxi East Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China.,Yunnan University of Traditional Chinese Medicine, No. 1076, Yuhua Rd., Chenggong District, Kunming, 650500, Yunnan Province, People's Republic of China
| | - Da-Ping Qin
- Gansu University of Chinese Medicine, No. 35, Dingxi East Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China.,Affiliated Hospital of Gansu University of Chinese Medicine, No. 735, Jiayuguan West Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China
| | - Xiao-Gang Zhang
- Gansu University of Chinese Medicine, No. 35, Dingxi East Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China. .,Affiliated Hospital of Gansu University of Chinese Medicine, No. 735, Jiayuguan West Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China.
| | - Zhi-Peng Wang
- Gansu University of Chinese Medicine, No. 35, Dingxi East Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China.,Affiliated Hospital of Gansu University of Chinese Medicine, No. 735, Jiayuguan West Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China
| | - Zun Tong
- Gansu University of Chinese Medicine, No. 35, Dingxi East Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China.,Affiliated Hospital of Gansu University of Chinese Medicine, No. 735, Jiayuguan West Rd., Chengguan District, Lanzhou, 730000, Gansu Province, People's Republic of China
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Dharmajaya R, Sari DK, Ganie RA. A Comparison of the Quality of Sleep between Pre and Post-Surgery Cervical Herniated Nucleus Pulposus Patients Utilizing the Anterior Discectomy Method. Open Access Maced J Med Sci 2017; 5:948-954. [PMID: 29362625 PMCID: PMC5771301 DOI: 10.3889/oamjms.2017.209] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2017] [Revised: 09/24/2017] [Accepted: 09/29/2017] [Indexed: 11/29/2022] Open
Abstract
BACKGROUND Herniated Nucleus Pulposus (HNP) is the prolapse of the intervertebral disk through a tear in the annulus fibrosus. This causes nerve root compression with clinical pain manifestation and affects the quality of sleep. AIM The aim of this study was find out the comparison in the quality of sleep between before (pre) and after (post) surgery cervical HNP patients. METHODS This study was a retrospective cohort study. Ninety patients were asked to complete the Pittsburgh Sleep Quality Index (PSQI) questionnaire. All data which has been computed were analysed with the McNemar test. RESULT The outcome reveals that from 90 patient`s cervical HNP, 81 (90%) were 40 years old age group and 66 (73.3%) of them were women. The result showed that 66 (73.3%) patients have a bad sleep quality before surgery. Surgery has increased the quality of sleep after surgery 66 (73.3%) patients had good sleep quality. There was a significant difference in the quality of sleep pre and post operation (p = 0.001). CONCLUSION There was a significant difference in the quality of sleep between pre and post operation cervical HNP patient utilising anterior discectomy methods.
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Wachowski MM, Weiland J, Wagner M, Gezzi R, Kubein-Meesenburg D, Nägerl H. Kinematics of cervical segments C5/C6 in axial rotation before and after total disc arthroplasty. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2017; 26:2425-2433. [DOI: 10.1007/s00586-017-5073-z] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/13/2016] [Revised: 02/28/2017] [Accepted: 03/27/2017] [Indexed: 10/19/2022]
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Lee YC, Zotti MGT, Osti OL. Operative Management of Lumbar Degenerative Disc Disease. Asian Spine J 2016; 10:801-19. [PMID: 27559465 PMCID: PMC4995268 DOI: 10.4184/asj.2016.10.4.801] [Citation(s) in RCA: 44] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2016] [Accepted: 03/15/2016] [Indexed: 12/12/2022] Open
Abstract
Lumbar degenerative disc disease is extremely common. Current evidence supports surgery in carefully selected patients who have failed non-operative treatment and do not exhibit any substantial psychosocial overlay. Fusion surgery employing the correct grafting and stabilization techniques has long-term results demonstrating successful clinical outcomes. However, the best approach for fusion remains debatable. There is some evidence supporting the more complex, technically demanding and higher risk interbody fusion techniques for the younger, active patients or patients with a higher risk of non-union. Lumbar disc arthroplasty and hybrid techniques are still relatively novel procedures despite promising short-term and mid-term outcomes. Long-term studies demonstrating superiority over fusion are required before these techniques may be recommended to replace fusion as the gold standard. Novel stem cell approaches combined with tissue engineering therapies continue to be developed in expectation of improving clinical outcomes. Results with appropriate follow-up are not yet available to indicate if such techniques are safe, cost-effective and reliable in the long-term.
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Affiliation(s)
- Yu Chao Lee
- Spinal Surgery Unit, Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, SA, Australia
| | | | - Orso Lorenzo Osti
- Calvary Health Care, North Adelaide Campus, North Adelaide, SA, Australia
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Biomechanics of the L5–S1 motion segment after total disc replacement – Influence of iatrogenic distraction, implant positioning and preoperative disc height on the range of motion and loading of facet joints. J Biomech 2015; 48:3283-91. [DOI: 10.1016/j.jbiomech.2015.06.023] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2015] [Revised: 05/18/2015] [Accepted: 06/21/2015] [Indexed: 11/23/2022]
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An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2015; 24:2056-64. [PMID: 25895882 DOI: 10.1007/s00586-015-3939-5] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/16/2014] [Revised: 04/06/2015] [Accepted: 04/06/2015] [Indexed: 01/08/2023]
Abstract
PURPOSE To report our 11-year minimum clinical and radiological outcomes, as well as complications of the Charite III total disc replacement (TDR). METHODS A total of 35 patients indicated for total disc replacement were implanted with the Charite III prosthesis. Clinical evaluation included visual analog scale (VAS) for back pain and the Oswestry disability index (ODI). Radiological parameters of intervertebral disc height (IDH), range of motion (ROM), lumbar lordosis, lumbar scoliosis and prosthesis position were evaluated. Complications and reoperation rates were also assessed. RESULTS Thirty-two patients had a minimum 11-year follow-up, and 33 prostheses were implanted. The mean follow-up time was 11.8 years, ranging from 11.3 to 13.8 years. Twenty-eight patients (87.5 %) had a successful outcome, as defined by the FDA. Reoperation was performed in 2 patients for adjacent segment degeneration and pedicle fracture (1 case each). Both VAS and ODI scores showed significant improvement compared to baseline. At the final follow-up, the ROM of both the index- and adjacent-level showed an obvious decrease. The IDH of the index level showed a tendency to decrease, but the difference was not significant. The IDH of adjacent levels were not significantly affected by the surgery. Mean lumbar lordosis was increased at the final follow-up, and lumbar scoliosis over 3° was observed in 12 patients (37.5%), with a mean angle of 5.6° (range 3°-12°). Of all 35 prostheses, 15 were left-shifted, 3 were right-shifted and 14 were just in the middle. In the coronal plane, 25 were rated as ideally placed, 5 were discretely shifted, 4 were slightly shifted and 1 was markedly shifted. In the sagittal plane, only 12 prostheses were rated as ideally placed, 14 were discretely shifted and 9 were suboptimally placed. Prosthesis subsidence was noted in 3 (9.4%) patients (the subsidence distances were 3.1, 4.2 and 2.8 mm, respectively). Heterotopic ossification was detected in 25 segments (71.4%), consisting of Class-I heterotopic ossification in 7 segments (20.0%), Class-II in 9 segments (25.7%), and Class-III in 9 segments (25.7%). Class-IV heterotopic ossification was not observed. CONCLUSION The cumulative survival was 100% at a mean follow-up of 11.8 years. Clinical and radiological results were satisfactory and long-term clinical results were maintained for a mean follow-up of 11.8 years. Reoperation and complication rates are acceptable, and our study does not substantiate the fear of reoperation or late complications. The results of our long-term follow-up indicate that, with strict indication, TDR is a safe and effective procedure as an alternative to lumbar fusion.
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Abstract
PURPOSE The primary goal of this Policy Statement is to educate patients, physicians, medical providers, reviewers, adjustors, case managers, insurers, and all others involved or affected by insurance coverage decisions regarding lumbar disc replacement surgery. PROCEDURES This Policy Statement was developed by a panel of physicians selected by the Board of Directors of ISASS for their expertise and experience with lumbar TDR. The panel's recommendation was entirely based on the best evidence-based scientific research available regarding the safety and effectiveness of lumbar TDR.
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15
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Zahari SN, Abd Latif MJ, Kadir MRA. The influence of preload application for vertebra segment in finite element modelling. 2014 IEEE CONFERENCE ON BIOMEDICAL ENGINEERING AND SCIENCES (IECBES) 2014. [DOI: 10.1109/iecbes.2014.7047485] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 09/01/2023]
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Which design and biomaterial factors affect clinical wear performance of total disc replacements? A systematic review. Clin Orthop Relat Res 2014; 472:3759-69. [PMID: 25002211 PMCID: PMC4397740 DOI: 10.1007/s11999-014-3751-2] [Citation(s) in RCA: 31] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
BACKGROUND Total disc replacement was clinically introduced to reduce pain and preserve segmental motion of the lumbar and cervical spine. Previous case studies have reported on the wear and adverse local tissue reactions around artificial prostheses, but it is unclear how design and biomaterials affect clinical outcomes. QUESTIONS/PURPOSES Which design and material factors are associated with differences in clinical wear performance (implant wear and periprosthetic tissue response) of (1) lumbar and (2) cervical total disc replacements? METHODS We performed a systematic review on the topics of implant wear and periprosthetic tissue response using an advanced search in MEDLINE and Scopus electronic databases. Of the 340 references identified, 33 were retrieved for full-text evaluation, from which 16 papers met the inclusion criteria (12 on lumbar disc replacement and five on cervical disc replacement; one of the included studies reported on both lumbar and cervical disc replacement), which involved semiquantitative analysis of wear and adverse local tissue reactions along with a description of the device used. An additional three papers were located by searching bibliographies of key articles. There were seven case reports, three case series, two case-control studies, and seven analytical studies. The Methodological Index for Non-randomized Studies (MINORS) Scale was used to score case series and case-control studies, which yielded mean scores of 10.3 of 16 and 17.5 of 24, respectively. In general, the case series (three) and case-control (two) studies were of good quality. RESULTS In lumbar regions, metal-on-polymer devices with mobile-bearing designs consistently generated small and large polymeric wear debris, triggering periprosthetic tissue activation of macrophages and giant cells, respectively. In the cervical regions, metal-on-polymer devices with fixed-bearing designs had similar outcomes. All metal-on-metal constructs tended to generate small metallic wear debris, which typically triggered an adaptive immune response of predominantly activated lymphocytes. There were no retrieval studies on one-piece prostheses. CONCLUSIONS This review provides evidence that design and biomaterials affect the type of wear and inflammation. However, clinical study design, followup, and analytical techniques differ among investigations, preventing us from drawing firm conclusions about the relationship between implant design and wear performance for both cervical and lumbar total disc replacement.
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Siepe CJ, Heider F, Wiechert K, Hitzl W, Ishak B, Mayer MH. Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5- to 10-year follow-up. Spine J 2014; 14:1417-31. [PMID: 24448028 DOI: 10.1016/j.spinee.2013.08.028] [Citation(s) in RCA: 62] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2013] [Revised: 07/21/2013] [Accepted: 08/22/2013] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT The role of fusion of lumbar motion segments for the treatment of intractable low back pain (LBP) from degenerative disc disease (DDD) without deformities or instabilities remains controversially debated. Total lumbar disc replacement (TDR) has been used as an alternative in a highly selected patient cohort. However, the amount of long-term follow-up (FU) data on TDR is limited. In the United States, insurers have refused to reimburse surgeons for TDRs for fear of delayed complications, revisions, and unknown secondary costs, leading to a drastic decline in TDR numbers. PURPOSE To assess the mid- and long-term clinical efficacy as well as patient safety of TDR in terms of perioperative complication and reoperation rates. STUDY DESIGN/SETTING Prospective, single-center clinical investigation of TDR with ProDisc II (Synthes, Paoli, PA, USA) for the treatment of LBP from lumbar DDD that has proven unresponsive to conservative therapy. PATIENT SAMPLE Patients with a minimum of 5-year FU after TDR, performed for the treatment of intractable and predominant (≥80%) axial LBP resulting from DDD without any deformities or instabilities. OUTCOME MEASURES Visual analog scale (VAS), Oswestry Disability Index (ODI), and patient satisfaction rates (three-scale outcome rating); complication and reoperation rates as well as elapsed time until revision surgery; patient's professional activity/employment status. METHODS Clinical outcome scores were acquired within the framework of an ongoing prospective clinical trial. Patients were examined preoperatively, 3, 6, and 12 months postoperatively, annually from then onward. The data acquisition was performed by members of the clinic's spine unit including medical staff, research assistants, and research nurses who were not involved in the process of pre- or postoperative decision-making. RESULTS The initial cohort consisted of 201 patients; 181 patients were available for final FU, resembling a 90.0% FU rate after a mean FU of 7.4 years (range 5.0-10.8 years). The overall results revealed a highly significant improvement from baseline VAS and ODI levels at all postoperative FU stages (p<.0001). VAS scores demonstrated a slight (from VAS 2.6 to 3.3) but statistically significant deterioration from 48 months onward (p<.05). Patient satisfaction rates remained stable throughout the entire postoperative course, with 63.6% of patients reporting a highly satisfactory or a satisfactory (22.7%) outcome, whereas 13.7% of patients were not satisfied. The overall complication rate was 14.4% (N=26/181). The incidence of revision surgeries for general and/or device-related complications was 7.2% (N=13/181). Two-level TDRs demonstrated a significant improvement of VAS and ODI scores in comparison to baseline levels (p<.05). Nevertheless, the results were significantly inferior in comparison to one-level cases and were associated with higher complication (11.9% vs. 27.6%; p=.03) and inferior satisfaction rates (p<.003). CONCLUSIONS Despite the fact that the current data comprises the early experiences and learning curve associated with a new surgical technique, the results demonstrate satisfactory and maintained mid- to long-term clinical results after a mean FU of 7.4 years. Patient safety was proven with acceptable complication and reoperation rates. Fear of excessive late complications or reoperations following the primary TDR procedure cannot be substantiated with the present data. In carefully selected cases, TDR can be considered a viable treatment alternative to lumbar fusion for which spine communities around the world seem to have accepted mediocre clinical results as well as obvious and significant drawbacks.
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Affiliation(s)
- Christoph J Siepe
- Schön Klinik Munich Harlaching, Spine Center, Academic Teaching Hospital of the Paracelsus Medical University Salzburg (AU), Harlachinger Str. 51, D-81547 Munich, Germany.
| | - Franziska Heider
- Schön Klinik Munich Harlaching, Spine Center, Academic Teaching Hospital of the Paracelsus Medical University Salzburg (AU), Harlachinger Str. 51, D-81547 Munich, Germany
| | - Karsten Wiechert
- Department of Spinal Surgery, Hessingpark Clinic, Hessingstrasse 17; D-86199 Augsburg, Germany
| | - Wolfgang Hitzl
- Paracelsus Medical University Salzburg, Biostatistics, Research Office, Strubergasse 21, 5020 Salzburg, Austria
| | - Basem Ishak
- Department of Neurosurgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120 Heidelberg, Germany
| | - Michael H Mayer
- Schön Klinik Munich Harlaching, Spine Center, Academic Teaching Hospital of the Paracelsus Medical University Salzburg (AU), Harlachinger Str. 51, D-81547 Munich, Germany
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Landi A. Elastic resistance of the spine: Why does motion preservation surgery almost fail? World J Clin Cases 2013; 1:134-139. [PMID: 24303484 PMCID: PMC3845953 DOI: 10.12998/wjcc.v1.i4.134] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2013] [Revised: 04/11/2013] [Accepted: 06/10/2013] [Indexed: 02/05/2023] Open
Abstract
Single metamere motility should not be interpreted merely as a movement on the 3 planes but also, and above all, as elastic resistance to dynamic stress on these 3 planes. In the light of this consideration, the aim of motion preservation is to neutralize excessive movements while preserving the physiological biomechanical properties of the metamere involved to interrupt the progression of degenerative processes and to prevent adjacent segment disease. Despite the fact that a myriad of devices have been developed with the purpose of achieving dynamic neutralization of the spine, there are now some doubts regarding the true efficacy of these devices.
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Wachowski MM, Wagner M, Weiland J, Dörner J, Raab BW, Dathe H, Gezzi R, Kubein-Meesenburg D, Nägerl H. Does total disc arthroplasty in C3/C4-segments change the kinematic features of axial rotation? J Biomech 2013; 46:1739-45. [PMID: 23659912 DOI: 10.1016/j.jbiomech.2013.03.027] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2012] [Revised: 02/27/2013] [Accepted: 03/30/2013] [Indexed: 10/26/2022]
Abstract
We analyze how kinematic properties of C3/C4-segments are modified after total disc arthroplasty (TDA) with PRESTIGE(®) and BRYAN(®) Cervical Discs. The measurements were focused on small ranges of axial rotation (<0.8°) in order to investigate physiologic rotations, which frequently occur in vivo. Eight human segments were stimulated by triangularly varying, axially directed torque. By using a 6D-measuring device with high resolution the response of segmental motion was characterised by the instantaneous helical axis (IHA). Position, direction, and migration rate of the IHA were measured before and after TDA. External parameters: constant axially directed pre-load, constant flexional/extensional and lateral-flexional pre-torque. The applied axial torque and IHA-direction did not run parallel. The IHA-direction was found to be rotated backwards and largely independent of the rotational angle, amount of axial pre-load, size of pre-torque, and TDA. In the intact segments pre-flexion/extension hardly influenced IHA-positions. After TDA, IHA-position was shifted backwards significantly (BRYAN-TDA: ≈8mm; PRESTIGE-TDA: ≈6mm) and in some segments laterally as well. Furthermore it was significantly shifted ventrally by pre-flexion and dorsally by pre-extension. The rate of lateral IHA-migration increased significantly after BRYAN-TDA during rightward or leftward rotations. In conclusion after the TDA the IHA-positions shifted backwards with significant increase in variability of the IHA-positions after the BRYAN-TDA more than in PRESTIGE-TDA. The TDA-procedure altered the segment kinematics considerably. TDA causes additional translations of the vertebrae, which superimpose the kinematics of the adjacent levels. The occurrence of adjacent level disease (ALD) is not excluded after the TDA for kinematical reasons.
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Affiliation(s)
- Martin Michael Wachowski
- Department of Trauma Surgery, Plastic and Reconstructive Surgery, University of Göttingen, Germany.
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Kim YE, Choi HW. Paraspinal muscle activation in accordance with mechanoreceptors in the intervertebral discs. Proc Inst Mech Eng H 2013; 227:138-47. [PMID: 23513985 DOI: 10.1177/0954411912463322] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Paraspinal muscle forces were derived computationally based on the hypothesis that the intervertebral disc has a transducer function and the muscle is activated according to a sensor-driving control mechanism. A three-dimensional finite element model of the musculoskeletal system, which consisted of a detailed whole lumbar spine, pelvis, simplified trunk model, and muscles, was developed and combined with an optimization technique to calculate muscle forces in isometric forward flexed and erect standing postures. Minimization of deviations in the nucleus pressure and averaged tensile stress in the annulus fibers at five discs was used for muscle force calculations. The results indicated that all the muscles were properly activated to maintain posture and stabilize the lumbar spine. The nucleus pressure difference was decreased during the iterative calculations and its resulting value at the L4/L5 level was consistent with in vivo measurements. Muscle activation produced vertebra motion, which resulted in a relatively uniform stress distribution in the intervertebral discs. This can minimize the risk of injury at a specific level and increase the ability of the spine to sustain a load.
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Affiliation(s)
- Young Eun Kim
- Department of Mechanical Engineering, Dankook University, Yongin-si, Korea.
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Daniels AH, Paller DJ, Koruprolu S, Palumbo MA, Crisco JJ. Dynamic biomechanical examination of the lumbar spine with implanted total spinal segment replacement (TSSR) utilizing a pendulum testing system. PLoS One 2013; 8:e57412. [PMID: 23451222 PMCID: PMC3581457 DOI: 10.1371/journal.pone.0057412] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2012] [Accepted: 01/22/2013] [Indexed: 11/18/2022] Open
Abstract
Background Biomechanical investigations of spinal motion preserving implants help in the understanding of their in vivo behavior. In this study, we hypothesized that the lumbar spine with implanted total spinal segment replacement (TSSR) would exhibit decreased dynamic stiffness and more rapid energy absorption compared to native functional spinal units under simulated physiologic motion when tested with the pendulum system. Methods Five unembalmed, frozen human lumbar functional spinal units were tested on the pendulum system with axial compressive loads of 181 N, 282 N, 385 N, and 488 N before and after Flexuspine total spinal segment replacement implantation. Testing in flexion, extension, and lateral bending began by rotating the pendulum to 5°; resulting in unconstrained oscillatory motion. The number of rotations to equilibrium was recorded and bending stiffness (N-m/°) was calculated and compared for each testing mode. Results The total spinal segment replacement reached equilibrium with significantly fewer cycles to equilibrium compared to the intact functional spinal unit at all loads in flexion (p<0.011), and at loads of 385 N and 488 N in lateral bending (p<0.020). Mean bending stiffness in flexion, extension, and lateral bending increased with increasing load for both the intact functional spinal unit and total spinal segment replacement constructs (p<0.001), with no significant differences in stiffness between the intact functional spinal unit and total spinal segment replacement in any of the test modes (p>0.18). Conclusions Lumbar functional spinal units with implanted total spinal segment replacement were found to have similar dynamic bending stiffness, but absorbed energy at a more rapid rate than intact functional spinal units during cyclic loading with an unconstrained pendulum system. Although the effects on clinical performance of motion preserving devices is not fully known, these results provide further insight into the biomechanical behavior of this device under approximated physiologic loading conditions.
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Affiliation(s)
- Alan H Daniels
- Department of Orthopaedics, Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, Rhode Island, United States of America.
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Jahng TA, Kim YE, Moon KY. Comparison of the biomechanical effect of pedicle-based dynamic stabilization: a study using finite element analysis. Spine J 2013; 13:85-94. [PMID: 23266148 DOI: 10.1016/j.spinee.2012.11.014] [Citation(s) in RCA: 65] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/07/2011] [Revised: 03/23/2012] [Accepted: 11/08/2012] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Recently, nonfusion pedicle-based dynamic stabilization systems (PBDSs) have been developed and used in the management of degenerative lumbar spinal diseases. Still effects on spinal kinematics and clinical effects are controversial. Little biomechanical information exists for providing biomechanical characteristics of pedicle-based dynamic stabilization according to the PBDS design before clinical implementation. PURPOSE To investigate the effects of implanting PBDSs into the spinal functional unit and elucidate the differences in biomechanical characteristics according to different materials and design. STUDY DESIGN The biomechanical effects of implantation of PBDS were investigated using the nonlinear three-dimensional finite element model of L4-L5. METHODS An already validated three-dimensional, intact osteoligamentous L4-L5 finite element model was modified to incorporate the insertion of pedicle screws. The implanted models were constructed after modifying the intact model to simulate postoperative changes using four different fixation systems. Four models instrumented with PBDS (Dynesys, NFlex, and polyetheretherketone [PEEK]) and rigid fixation systems (conventional titanium rod) were developed for comparison. The instrumented models were compared with those of the intact and rigid fixation model. Range of motion (ROM) in three motion planes, center of rotation (COR), force on the facet joint, and von Mises stress distribution on the vertebral body and implants with flexion-extension were compared among the models. RESULTS Simulated results demonstrated that implanted segments with PBDSs have limited ROM when compared with the intact spine. Flexion motion was the most limited, and axial rotation was the least limited, after device implantation. Among the PBDS selected in this analysis, the NFlex system had the closest instantaneous COR compared with the intact model and a higher ROM compared with other PBDS. Contact force on the facet joint in extension increased with an increase of moment in Dynesys and NFlex; however, the rigid or PEEK rod fixation revealed no facet contact force. CONCLUSIONS Implanted segments with PBDSs have limited ROM when compared with the intact spine. Center of rotation and stress distribution differed according to the design and materials used. These biomechanical effects produced a nonphysiological stress on the functional spinal unit when they were implanted. The biomechanical effects of current PBDSs should be carefully considered before clinical implementation.
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Affiliation(s)
- Tae-Ahn Jahng
- Department of Neurosurgery, Seoul National University, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do 464-707, Korea
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Jacobs WCH, van der Gaag NA, Kruyt MC, Tuschel A, de Kleuver M, Peul WC, Verbout AJ, Oner FC. Total disc replacement for chronic discogenic low back pain: a Cochrane review. Spine (Phila Pa 1976) 2013; 38:24-36. [PMID: 22996268 DOI: 10.1097/brs.0b013e3182741b21] [Citation(s) in RCA: 64] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Systematic literature review. OBJECTIVE To assess the effect of total disc replacement for chronic low back pain due to lumbar degenerative disc disease compared with fusion or other treatment options. SUMMARY OF BACKGROUND DATA There is an increasing use in disc replacement devices for degenerative disc disease, but their effectiveness compared with other interventions such as fusion of the motion segment or conservative treatment remains unclear. METHODS A comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and FDA trials register was conducted. Randomized controlled trials comparing total disc replacement with any other intervention for degenerative disc disease were included. Risk of bias was assessed using the criteria of the Cochrane Back Review Group. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias, and extracted data. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences. RESULTS We included 7 randomized controlled trials with a follow-up of 24 months. There is risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared disc replacement with rehabilitation and found a significant advantage in favor of surgery, which, however, did not reach the predefined threshold. Six studies compared disc replacement with fusion and found that the mean improvement in visual analogue scale score of back pain was 5.2 mm higher (2 studies; 95% confidence interval 0.2-10.3) with a low quality of evidence. The improvement of Oswestry disability index score at 24 months in the disc replacement group was 4.3 points more than in the fusion group (5 studies; 95% confidence interval 1.85-6.68) with a low quality of evidence. Both upper bounds of the confidence intervals were below the predefined clinically relevant difference. CONCLUSION Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery.
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Affiliation(s)
- Wilco C H Jacobs
- Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands.
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Jin YJ, Kim YE, Seo JH, Choi HW, Jahng TA. Effects of rod stiffness and fusion mass on the adjacent segments after floating mono-segmental fusion: a study using finite element analysis. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2012; 22:1066-77. [PMID: 23242620 DOI: 10.1007/s00586-012-2611-6] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/30/2011] [Revised: 11/26/2012] [Accepted: 12/04/2012] [Indexed: 10/27/2022]
Abstract
PURPOSE The aims of the present study were to compare the biomechanical effects on the adjacent segments after mono-segmental floating fusion with posterior semi-rigid or rigid stabilization, and to evaluate the effect of the amount of fusion mass on the biomechanical differences. METHODS A detailed, nonlinear L1-S1 finite element model had been developed and validated. Then five models were reconstructed by different fixation techniques on the L3-L4 level: rigid fixation with an interbody spacer (Ti + IS), rigid fixation with a large interbody spacer (Ti + IS_all), semi-rigid fixation with an interbody spacer (PEEK + IS), semi-rigid fixation with a large interbody spacer (PEEK + IS_all), and semi-rigid fixation only (PEEK). Analyses were conducted for the case of erect standing position, flexion, and extension motion. RESULTS At L1-L2 and L2-L3, PEEK + IS demonstrated less inter-segmental rotation and nucleus pressure increments from the intact model compared with Ti + IS. The L4-L5 and L5-S1 levels showed slightly higher values with PEEK + IS, but these differences among the instrumented models were not significant. The motion difference based on the fusion mass at the adjacent levels was at most 3%. All instrumentation cases generated a 55% higher facet contact force at the lower adjacent level (L4-L5) compared to that of the intact model during 26° extension and the largest increment was detected at the upper adjacent level (L2-L3) in the Ti + IS. Instrumentation with Ti + IS markedly increased the stress in the intervertebral disk at the upper adjacent level, while the stress with PEEK + IS appeared largest at the lower adjacent level. CONCLUSIONS Posterior instrumentation with semi-rigid rods may lower the incidence of disk and facet degeneration in the upper adjacent segment compared to rigid rods. On the other hand, the possibility of facet degeneration will be similar for all instrumentation devices in the lower adjacent segment in the long-term. The stiffness difference between rigid and semi-rigid rods on the changes in the adjacent motion segments was more crucial than amount of fusion mass.
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Affiliation(s)
- Yong Jun Jin
- Department of Neurosurgery, Inje University College of Medicine, Seoul Paik Hospital, Seoul, Korea
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Dynamic biomechanical examination of the lumbar spine with implanted total disc replacement using a pendulum testing system. Spine (Phila Pa 1976) 2012; 37:E1438-43. [PMID: 22869057 PMCID: PMC3778666 DOI: 10.1097/brs.0b013e31826b39d7] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Biomechanical cadaver investigation. OBJECTIVE To examine dynamic bending stiffness and energy absorption of the lumbar spine with and without implanted total disc replacement (TDR) under simulated physiological motion. SUMMARY OF BACKGROUND DATA The pendulum testing system is capable of applying physiological compressive loads without constraining motion of functional spinal units (FSUs). The number of cycles to equilibrium observed under pendulum testing is a measure of the energy absorbed by the FSU. METHODS Five unembalmed, frozen human lumbar FSUs were tested on the pendulum system with axial compressive loads of 181 N, 282 N, 385 N, and 488 N before and after Synthes ProDisc-L TDR implantation. Testing in flexion, extension, and lateral bending began by rotating the pendulum to 5º resulting in unconstrained oscillatory motion. The number of rotations to equilibrium was recorded and bending stiffness (N·m/º) was calculated and compared for each testing mode. RESULTS In flexion/extension, the TDR constructs reached equilibrium with significantly (P < 0.05) fewer cycles than the intact FSU with compressive loads of 282 N, 385 N, and 488 N. Mean dynamic bending stiffness in flexion, extension, and lateral bending increased significantly with increasing load for both the intact FSU and TDR constructs (P < 0.001). In flexion, with increasing compressive loading from 181 N to 488 N, the bending stiffness of the intact FSUs increased from 4.0 N·m/º to 5.5 N·m/º, compared with 2.1 N·m/º to 3.6 N·m/º after TDR implantation. At each compressive load, the intact FSU was significantly stiffer than the TDR (P < 0.05). CONCLUSION Lumbar FSUs with implanted TDR were found to be less stiff, but absorbed more energy during cyclic loading with an unconstrained pendulum system. Although the effects on clinical performance of motion-preserving devices are not fully known, these results provide further insight into the biomechanical behavior of these devices under approximated physiological loading conditions.
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Jacobs W, Van der Gaag NA, Tuschel A, de Kleuver M, Peul W, Verbout AJ, Oner FC. Total disc replacement for chronic back pain in the presence of disc degeneration. Cochrane Database Syst Rev 2012:CD008326. [PMID: 22972118 DOI: 10.1002/14651858.cd008326.pub2] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
BACKGROUND In the search for better surgical treatment of chronic low-back pain (LBP) in the presence of disc degeneration, total disc replacement has received increasing attention in recent years. A possible advantage of total disc replacement compared with fusion is maintained mobility at the operated level, which has been suggested to reduce the chance of adjacent segment degeneration. OBJECTIVES The aim of this systematic review was to assess the effect of total disc replacement for chronic low-back pain in the presence of lumbar disc degeneration compared with other treatment options in terms of patient-centred improvement, motion preservation and adjacent segment degeneration. SEARCH METHODS A comprehensive search in Cochrane Back Review Group (CBRG) trials register, CENTRAL, MEDLINE, EMBASE, BIOSIS, ISI, and the FDA register was conducted. We also checked the reference lists and performed citation tracking of included studies. SELECTION CRITERIA We included randomised controlled trials (RCTs) comparing total disc replacement with any other intervention for degenerative disc disease. DATA COLLECTION AND ANALYSIS We assessed risk of bias per study using the criteria of the CBRG. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies and assessed risk of bias of the studies. Results and upper bounds of confidence intervals were compared against predefined clinically relevant differences. MAIN RESULTS We included 40 publications, describing seven unique RCT's. The follow-up of the studies was 24 months, with only one extended to five years. Five studies had a low risk of bias, although there is a risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared disc replacement against rehabilitation and found a statistically significant advantage in favour of surgery, which, however, did not reach the predefined threshold for clinical relevance. Six studies compared disc replacement against fusion and found that the mean improvement in VAS back pain was 5.2 mm (of 100 mm) higher (two studies, 676 patients; 95% confidence interval (CI) 0.18 to 10.26) with a low quality of evidence while from the same studies leg pain showed no difference. The improvement of Oswestry score at 24 months in the disc replacement group was 4.27 points more than in the fusion group (five studies; 1207 patients; 95% CI 1.85 to 6.68) with a low quality of evidence. Both upper bounds of the confidence intervals for VAS back pain and Oswestry score were below the predefined clinically relevant difference. Choice of control group (circumferential or anterior fusion) did not appear to result in different outcomes. AUTHORS' CONCLUSIONS Although statistically significant, the differences between disc replacement and conventional fusion surgery for degenerative disc disease were not beyond the generally accepted clinical important differences with respect to short-term pain relief, disability and Quality of Life. Moreover, these analyses only represent a highly selected population. The primary goal of prevention of adjacent level disease and facet joint degeneration by using total disc replacement, as noted by the manufacturers and distributors, was not properly assessed and not a research question at all. Unfortunately, evidence from observational studies could not be used because of the high risk of bias, while these could have improved external validity assessment of complications in less selected patient groups. Non-randomised studies should however be very clear about patient selection and should incorporate independent, blinded outcome assessment, which was not the case in the excluded studies. Therefore, because we believe that harm and complications may occur after years, we believe that the spine surgery community should be prudent about adopting this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low-back pain in selected patients, and in the short term is at least equivalent to fusion surgery.
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Affiliation(s)
- Wilco Jacobs
- Department of Neurosurgery, Leiden University Medical Center, Leiden, Netherlands.
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Abstract
STUDY DESIGN The biomechanical behavior of a biomimetic artificial intervertebral disc (AID) was characterized in vitro in axial compression and compared with natural disc behavior. OBJECTIVE To evaluate the strength and durability of a novel biomimetic AID and to demonstrate whether its axial deformation behavior is similar to that of a natural disc. SUMMARY OF BACKGROUND DATA Current clinically used AIDs have reasonable success rates. However, because of their nonphysiological design, spinal mechanics are altered. To avoid long-term complications, a novel biomimetic AID, with a nucleus-annulus structure and osmotic swelling properties has been developed. METHODS Eighteen AIDs in total were tested in axial compression. Six were loaded monotonically to determine strength. Six were tested in fatigue (600-6000 N). Another 6 were used to characterize the axial creep and dynamic behavior (0.01-10 Hz). Creep and dynamic response were also determined for 4 AIDs after fatigue loading. RESULTS The AIDs remained intact up to 15 kN and 10 million cycles. The creep and dynamic behavior were similar to the natural disc behavior, except for hysteresis, which was 20% to 30% higher. After fatigue, creep decreased from 4% to 1%, stiffness increased 2-fold, and hysteresis was reduced to that for a normal disc. CONCLUSION A strong and durable AID design was introduced. Compared with current clinical articulating AIDs, this biomimetic AID introduces the natural disc annulus-nucleus structure, resulting in axial behavior closer to that of the natural disc.
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Austen S, Punt IM, Cleutjens JPM, Willems PC, Kurtz SM, MacDonald DW, van Rhijn LW, van Ooij A. Clinical, radiological, histological and retrieval findings of Activ-L and Mobidisc total disc replacements: a study of two patients. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2012; 21 Suppl 4:S513-20. [PMID: 22245852 DOI: 10.1007/s00586-011-2141-7] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/21/2011] [Revised: 11/14/2011] [Accepted: 12/25/2011] [Indexed: 10/14/2022]
Abstract
INTRODUCTION This study evaluates the short-term clinical outcome, radiological, histological and device retrieval findings of two patients with second generation lumbar total disc replacement (TDR). MATERIALS AND METHODS The first patient had a single level L4-L5 Activ-L TDR, the second patient a L4-L5 Mobidisc and L5-S1 Activ-L TDR. The TDRs were implanted elsewhere and had implantation times between 1.3 and 2.8 years. RESULTS Plain radiographs and CT-scanning showed slight subsidence of the Activ-L TDR in both patients and facet joint degeneration. The patients underwent revision surgery because of recurrent back and leg pain. After removal of the TDR and posterolateral fusion, the pain improved. Histological examination revealed large ultrahigh molecular weight polyethylene (UHMWPE) particles and giant cells in the retrieved tissue surrounding the Mobidisc. The particles in the tissue samples of the Activ-L TDR were smaller and contained in macrophages. Retrieval analysis of the UHMWPE cores revealed evidence of minor adhesive and abrasive wear with signs of impingement in both TDR designs. CONCLUSION Although wear was unrelated to the reason for revision, this study demonstrates the presence of UHMWPE particles and inflammatory cells in second generation TDR. Long-term follow-up after TDR is indicated for monitoring wear and implant status.
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Affiliation(s)
- Shennah Austen
- Department of Orthopaedic Surgery, Maastricht University Medical Center, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands
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Knell SC, Kircher P, Dennler M, Montavon PM, Voss K, Hurter K. Angle of insertion and confirmation of angles measured after in vitro implantation during laminar vertebral stabilization in vertebral columns obtained from canine cadavers. Am J Vet Res 2011; 72:1674-80. [PMID: 22126697 DOI: 10.2460/ajvr.72.12.1674] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
OBJECTIVE To determine angles of insertion for laminar vertebral fixation of L1 and L2 by use of a locking plate in dogs and to confirm screw placement by use of computed tomography (CT). SAMPLE Vertebral specimens harvested from 8 canine cadavers. PROCEDURES The point of insertion and minimum and maximum insertion angles for laminar and facet screws for laminar vertebral stabilization were determined by use of CT. A precontoured locking plate was then placed by use of 1 locking screw in the lamina of each lumbar vertebra and 1 nonlocking screw in the facet joint. The position and angle of the screws were examined by use of CT, and penetration into the vertebral canal was recorded. RESULTS Mean ± SD insertion angles for L1 and L2 were 18 ± 4° and 21 ± 5° toward the vertebral canal and 11 ± 4.4° and 10 ± 3° in a dorsal direction, respectively. Insertion angles for the facet joint were between 24 ± 4° ventrally and 12 ± 2° dorsally. Insertion of the screw did not penetrate the vertebral canal for 23 of 24 (96%) screws. For 23 of 24 inserted screws, the previously determined angle was maintained and purchase of bone and cortices was satisfactory. CONCLUSIONS AND CLINICAL RELEVANCE Placement of laminar and facet screws in canine vertebrae was possible and can be performed safely if angles of insertion determined pre-operatively via CT are maintained.
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Affiliation(s)
- Sebastian C Knell
- Department of Small Animal Surgery, Vetsuisse Faculty, University of Zurich, 8057 Zurich, Switzerland.
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Knell SC, Bürki A, Hurter K, Ferguson SJ, Montavon PM. Biomechanical comparison after in vitro laminar vertebral stabilization and vertebral body plating of the first and second lumbar vertebrae in specimens obtained from canine cadavers. Am J Vet Res 2011; 72:1681-6. [DOI: 10.2460/ajvr.72.12.1681] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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van den Broek PR, Huyghe JM, Wilson W, Ito K. Design of next generation total disk replacements. J Biomech 2011; 45:134-40. [PMID: 22035640 DOI: 10.1016/j.jbiomech.2011.09.017] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2011] [Revised: 09/15/2011] [Accepted: 09/20/2011] [Indexed: 12/01/2022]
Abstract
To improve the treatments for low back pain, new designs of total disk replacement have been proposed. The question is how well these designs can act as a functional replacement of the intervertebral disk. Four finite element models were made, for four different design concepts, to determine how well they can mimic the physiological intervertebral disk mechanical function. The four designs were a homogenous elastomer, a multi-stiffness elastomer, an elastomer with fiber jacket, and a hydrogel with fiber jacket. The best material properties of the four models were determined by optimizing the model behavior to match the behavior of the intervertebral disk in flexion-extension, axial rotation, and lateral bending. It was shown that neither a homogeneous elastomer nor a multi-stiffness elastomer could mimic the non-linear behavior within the physiological range of motion. Including a fiber jacket around an elastomer allowed for physiological motion in all degrees of freedom. Replacing the elastomer by a hydrogel yielded similar good behavior. Mimicking the non-linear behavior of the intervertebral disk, in the physiological range of motion is essential in maintaining and restoring spinal motion and in protecting surrounding tissues like the facet joints or adjacent segments. This was accomplished with designs mimicking the function of the annulus fibrosus.
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Affiliation(s)
- Peter R van den Broek
- Department of Biomedical Engineering, Eindhoven University of Technology, 5600 MB Eindhoven, The Netherlands
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Mayer HM, Siepe CJ. Prosthetic total disk replacement--can we learn from total hip replacement? Orthop Clin North Am 2011; 42:543-54, viii. [PMID: 21944590 DOI: 10.1016/j.ocl.2011.07.008] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/02/2023]
Abstract
Total lumbar disk replacement has become a routine procedure in many countries. However, discussions regarding its use are ongoing. Issues focus on patient selection, technical limitations, and avoidance or management of complications or long-term outcomes. A review of the development of this technology, since the development of the first successful implantation of a total lumbar disk prosthesis in 1984, shows an amazing analogy to the history of total hip replacement. This article is a one-to-one comparison of the evolution of total hip and total lumbar disk replacement from "skunk works" to scientific evidence.
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Costi JJ, Freeman BJC, Elliott DM. Intervertebral disc properties: challenges for biodevices. Expert Rev Med Devices 2011; 8:357-76. [PMID: 21542708 DOI: 10.1586/erd.11.1] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
Intervertebral disc biodevices that employ motion-preservation strategies (e.g., nucleus replacement, total disc replacement and posterior stabilization devices) are currently in use or in development. However, their long-term performance is unknown and only a small number of randomized controlled trials have been conducted. In this article, we discuss the following biodevices: interbody cages, nuclear pulposus replacements, total disc replacements and posterior dynamic stabilization devices, as well as future biological treatments. These biodevices restore some function to the motion segment; however, contrary to expectations, the risk of adjacent-level degeneration does not appear to have been reduced. The short-term challenge is to replicate the complex biomechanical function of the motion segment (e.g., biphasic, viscoelastic behavior and nonlinearity) to improve the quality of motion and minimize adjacent level problems, while ensuring biodevice longevity for the younger, more active patient. Biological strategies for regeneration and repair of disc tissue are being developed and these offer exciting opportunities (and challenges) for the longer term. Responsible introduction and rigorous assessment of these new technologies are required. In this article, we will describe the properties of the disc, explore biodevices currently in use for the surgical treatment of low back pain (with an emphasis on lumbar total disc replacement) and discuss future directions for biological treatments. Finally, we will assess the challenges ahead for the next generation of biodevices designed to replace the disc.
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Affiliation(s)
- John J Costi
- School of Computer Science, Engineering & Mathematics, Faculty of Science & Engineering, Flinders University, GPO Box 2100, Adelaide, South Australia 5001, Australia.
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Glenn JS, Yaker J, Guyer RD, Ohnmeiss DD. Anterior discectomy and total disc replacement for three patients with multiple recurrent lumbar disc herniations. Spine J 2011; 11:e1-6. [PMID: 21907631 DOI: 10.1016/j.spinee.2011.07.030] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2010] [Revised: 06/01/2011] [Accepted: 07/29/2011] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Although results of primary discectomy are generally excellent with relief of leg pain, recurrent lumbar disc herniation is relatively common ranging from 5% to 25%. Patients with recurrent herniation may undergo revision surgery; however, this carries with it increased risks and lower success rates. Many surgeons will advocate a fusion in addition to repeat discectomy after the third recurrent herniated disc. With the approval of lumbar total disc arthroplasty, there now exists another option for the patient with three or more recurrent disc herniations to preserve motion, theoretically decrease the rate of adjacent-level disease, and ameliorate the patient's symptoms. PURPOSE The purpose of this case report is to describe our experience using total disc replacement (TDR) in three patients after prior partial hemilaminectomy and discectomy for the treatment of a third and fourth recurrent lumbar disc herniation. STUDY DESIGN This article is a report of three cases from a spine specialty center describing an alternative surgical technique for patients with multiple recurrent lumbar disc herniation. METHODS Comprehensive chart review of three patients with recurrent lumbar herniation who underwent TDR. RESULTS Anterior discectomy and TDR were undertaken, and at most recent follow-up (8-12 months), all patients had improvement of their visual analog scale and Oswestry Disability Index. No patient had postoperative complications or reoperation. CONCLUSIONS Recurrent disc herniation is a relatively common problem that may be difficult to treat. Traditionally, a patient presenting with three or more recurrent disc herniation may likely have undergone revision discectomy with fusion. The current case report suggests that TDR may be an alternative option in select patients.
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Noailly J, Ambrosio L, Elizabeth Tanner K, Planell JA, Lacroix D. In silico evaluation of a new composite disc substitute with a L3-L5 lumbar spine finite element model. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2011; 21 Suppl 5:S675-87. [PMID: 21380572 DOI: 10.1007/s00586-011-1716-7] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/15/2009] [Revised: 01/26/2011] [Accepted: 02/06/2011] [Indexed: 10/18/2022]
Abstract
When the intervertebral disc is removed to relieve chronic pain, subsequent segment stabilization should restore the functional mechanics of the native disc. Because of partially constrained motions and the lack of intrinsic rotational stiffness ball-on-socket implants present many disadvantages. Composite disc substitutes mimicking healthy disc structures should be able to assume the role expected for a disc substitute with fewer restrictions than ball-on-socket implants. A biomimetic composite disc prototype including artificial nucleus fibre-reinforced annulus and endplates was modelled as an L4-L5 disc substitute within a L3-L5 lumbar spine finite element model. Different device updates, i.e. changes of material properties fibre distributions and volume fractions and nucleus placements were proposed. Load- and displacement-controlled rotations were simulated with and without body weight applied. The original prototype reduced greatly the flexibility of the treated segment with significant adjacent level effects under displacement-controlled or hybrid rotations. Device updates allowed restoring large part of the global axial and sagittal rotational flexibility predicted with the intact model. Material properties played a major role, but some other updates were identified to potentially tune the device behaviour against specific motions. All device versions altered the coupled intersegmental shear deformations affecting facet joint contact through contact area displacements. Loads in the bony endplates adjacent to the implants increased as the implant stiffness decreased but did not appear to be a strong limitation for the implant biomechanical and mechanobiological functionality. In conclusion, numerical results given by biomimetic composite disc substitutes were encouraging with greater potential than that offered by ball-on-socket implants.
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Affiliation(s)
- Jérôme Noailly
- Institute for Bioengineering of Catalonia Biomechanics and Mechanobiology, 4 Torre I, Planta 10, 08028 Barcelona, Spain.
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Ezquerro F, Vacas FG, Postigo S, Prado M, Simón A. Calibration of the finite element model of a lumbar functional spinal unit using an optimization technique based on differential evolution. Med Eng Phys 2011; 33:89-95. [DOI: 10.1016/j.medengphy.2010.09.010] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/07/2010] [Revised: 09/14/2010] [Accepted: 09/16/2010] [Indexed: 10/18/2022]
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The fate of facet joint and adjacent level disc degeneration following total lumbar disc replacement: a prospective clinical, X-ray, and magnetic resonance imaging investigation. Spine (Phila Pa 1976) 2010; 35:1991-2003. [PMID: 20881662 DOI: 10.1097/brs.0b013e3181d6f878] [Citation(s) in RCA: 39] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Prospective clinical, x-ray, and magnetic resonance imaging investigation following total lumbar disc replacement (TDR) with ProDisc II (Synthes, Paoli, PA). OBJECTIVE To examine the progression of adjacent level degeneration (ALD), facet joint degeneration (FJD) as well as associated risk factors following TDR. SUMMARY OF BACKGROUND DATA Fusion procedures have been associated with adjacent level morbidities and facet joint pathologies in a considerable number of patients. Whether the incidence of these negative side effects can be reduced with TDR remains unestablished. METHODS Clinical outcome scores Visual Analogue Scale (VAS), Oswestry Disability Index (ODI) and patient satisfaction rates were acquired within the framework of an ongoing prospective study with ProDisc II. The mean index-level ROM was established for every patient over the entire postoperative period from multiple flexion/extension x-ray images. The progression of ALD and FJD was evaluated from pre- and postoperative magnetic resonance images by 2 independent radiologists. RESULTS Results from 93 patients with an average follow-up of 53.4 months (range, 24.1-98.7 months) were included in this study. The overall results revealed a significant improvement from preoperative VAS and ODI levels (P < 0.0001).The incidence of ALD was 10.2% (n = 11/108 levels). The degenerative changes were mild and occurred late after surgery (mean, 65.2 months; range, 37.9-85.6 months). There was no significant correlation between index-level ROM and the occurrence of ALD (P > 0.05).Progression of FJD was observed in 20.0% of all facet joints (n = 44/220). FJD occurred significantly more often following TDR at the lumbosacral junction in comparison to the level above the lumbosacral junction (P < 0.02) and was observed more frequently at index-levels than at nonindex levels (P < 0.001).The degenerative changes were associated with a negative influence on postoperative outcome parameters VAS and ODI (P < 0.03) that were already detected early after surgery. The mean postoperative ROM was significantly lower in patients with progression of FJD in comparison to the remaining cohort (P < 0.0001). CONCLUSION TDR proved to have a beneficial effect with respect to adjacent level disc preservation. The degenerative changes were mild, occurred late after surgery and did not reveal a negative effect on postoperative clinical outcome. There was no significant correlation between index-level ROM and the occurrence of ALD (P > 0.05).TDR was, however, associated with a progression of index-level FJD in a considerable number of patients, particularly at the lumbosacral junction. Lower segmental mobility and less favorable clinical results point to the fact that a particular cohort of patients may predominantly be affected in which TDR shows inferior compatibility with the index-segment's biomechanics.
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The role of prosthesis design on segmental biomechanics: semi-constrained versus unconstrained prostheses and anterior versus posterior centre of rotation. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2010; 21 Suppl 5:S577-84. [PMID: 20830492 DOI: 10.1007/s00586-010-1552-1] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/18/2009] [Accepted: 08/01/2010] [Indexed: 12/31/2022]
Abstract
The purpose of this study was to evaluate the influence of different implant designs of total lumbar disc replacements on the segmental biomechanics of the lumbar spine. The unconstrained Charité, the semi-constrained Prodisc and a semi-constrained Prototype with more posterior centre of rotation than the Prodisc were tested in vitro using six human, lumbar spines L2-L5. The segmental lordosis was measured on plain radiographs and the range of motion (ROM) for all six degrees of freedom with a previously described spine tester. All prostheses were implanted at level L3-L4. Compared with the intact status all prostheses resulted in a significant increase of segmental lordosis (intact 5.1°; Charité 10.6°, p = 0.028; Prodisc 9.5°, p = 0.027; Prototype 8.9°, p = 0.028), significant increase of flexion/extension (intact 6.4°, Charité 11.3°, Prodisc 12.2°, Prototype 12.2°) and axial rotation (intact 1.3°, Charité 5.4°, Prodisc 3.9°, Prototype 4.2°). Lateral bending increased significantly only for the Charité (intact 7.7°; Charité 11.6°, p = 0.028; Prodisc 9.6°, Prototype 9.8°). The segmental lordosis after Prototype implantation was significantly lower compared with Charité (p = 0.024) and Prodisc (p = 0.044). No significant difference could be observed for segmental lordosis between Charité and Prodisc and for ROM between the two semi-constrained prosthesis Prodisc and Prototype. The axial rotation for the unconstrained Charité was significantly higher than for the semi-constrained prosthesis Prodisc and Prototype, flexion/extension and lateral bending did not differ. Summarizing, the unconstrained prosthesis design increased segmental lordosis and showed a tendency towards higher ROM for axial rotation/lateral bending and lower ROM for flexion/extension than a semi-constrained prosthesis. A more anterior centre of rotation in a semi-constrained prosthesis resulted in a higher increase of segmental lordosis after TDR than a semi-constrained prosthesis with more posterior centre of rotation. The location of the centre of rotation in a semi-constrained prosthesis did not alter the magnitude of ROM. Despite the different alterations of ROM and segmental lordosis due to implant design, these differences were negligible compared with the overall increase of ROM and segmental lordosis by the implantation of a TDR compared with the physiologic state.
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Kim KT, Lee SH, Suk KS, Lee JH, Jeong BO. Biomechanical changes of the lumbar segment after total disc replacement : charite(r), prodisc(r) and maverick(r) using finite element model study. J Korean Neurosurg Soc 2010; 47:446-53. [PMID: 20617091 DOI: 10.3340/jkns.2010.47.6.446] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2009] [Revised: 04/22/2010] [Accepted: 05/17/2010] [Indexed: 11/27/2022] Open
Abstract
OBJECTIVE The purpose of this study was to analyze the biomechanical effects of three different constrained types of an artificial disc on the implanted and adjacent segments in the lumbar spine using a finite element model (FEM). METHODS The created intact model was validated by comparing the flexion-extension response without pre-load with the corresponding results obtained from the published experimental studies. The validated intact lumbar model was tested after implantation of three artificial discs at L4-5. Each implanted model was subjected to a combination of 400 N follower load and 5 Nm of flexion/extension moments. ABAQUS version 6.5 (ABAQUS Inc., Providence, RI, USA) and FEMAP version 8.20 (Electronic Data Systems Corp., Plano, TX, USA) were used for meshing and analysis of geometry of the intact and implanted models. RESULTS Under the flexion load, the intersegmental rotation angles of all the implanted models were similar to that of the intact model, but under the extension load, the values were greater than that of the intact model. The facet contact loads of three implanted models were greater than the loads observed with the intact model. CONCLUSION Under the flexion load, three types of the implanted model at the L4-5 level showed the intersegmental rotation angle similar to the one measured with the intact model. Under the extension load, all of the artificial disc implanted models demonstrated an increased extension rotational angle at the operated level (L4-5), resulting in an increase under the facet contact load when compared with the adjacent segments. The increased facet load may lead to facet degeneration.
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Affiliation(s)
- Ki-Tack Kim
- Department of Orthopedic Surgery, School of Medicine, Kyung Hee University, Seoul, Korea
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