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ElNemer W, Kim A, Silva-Aponte J, Raad M, Azad T, Durand WM, Hassanzadeh H, Kebaish K, Jain A. An Analysis of the Complication Reports of Expandable Lumbar Interbody Cages in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. Orthopedics 2025; 48:e7-e14. [PMID: 39509577 DOI: 10.3928/01477447-20241104-02] [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] [Indexed: 11/15/2024]
Abstract
BACKGROUND Expandable lumbar interbody cages (ELICs) are commonly used for interbody fusion and provide lordotic correction by lengthening the anterior column of the vertebral spine. We sought to identify unique failure mechanisms and significant differences in the types of complications associated with ELICs as reported to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database. MATERIALS AND METHODS The MAUDE Database was analyzed for complication reports submitted for ELIC systems between January 2013 and July 2023. Reports were categorized by manufacturer, brand name, type of expandable cage, type of complication, year of complication, and reporter identity. Reports that were duplicated or had insufficient information were excluded from analysis. The top 5 manufacturers with the most implant-related complications were independently analyzed and compared. RESULTS A total of 821 reports were analyzed. The top 5 complications reported across all manufacturers were cage breakage during insertion (25.7%), postoperative migration without collapse (16.0%), postoperative collapse (15.6%), inserter breakage (11.1%), and tubing problems (3.0%). A significant difference was detected in complication type between manufacturers (χ2=557, P<.001). The largest number of reports (120, 14.6%) was in 2016. CONCLUSION With FDA approval of novel ELIC systems and the adoption of newer surgical techniques, understanding the range of potential complications is paramount in ensuring patient safety. This study of the MAUDE Database provides a comprehensive summary of adverse reported events associated with ELICs during the past decade. [Orthopedics. 2025;48(1):e7-e14.].
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Hejrati N, Martens B, Jost B, Bozinov O, Stienen MN. Failure of an expandable lumbar interbody spacer - a critical analysis of secondary collapse, pseudoarthrosis and revision rates after thoracolumbar fusion. 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 2025; 34:182-190. [PMID: 39455434 DOI: 10.1007/s00586-024-08539-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/28/2024] [Revised: 09/26/2024] [Accepted: 10/20/2024] [Indexed: 10/28/2024]
Abstract
PURPOSE To report on the failure rates of an expandable interbody spacer, used for spinal instrumented transforaminal lumbar interbody fusion (TLIF) or posterior thoracolumbar interbody fusion (PLIF). METHODS In this retrospective, single-center observational cohort study we reviewed consecutive PLIF/TLIF patients using the Catalyft™ PL and PL40 expandable titanium interbody implant (Medtronic, Minneapolis (USA)) between 07/2022 and 11/2023. We recorded patient demographics, surgical parameters, adverse events, radiological parameters and clinical outcomes according to the MacNab criteria. RESULTS We identified 53 patients (mean age 68.6 ± 11.5 years; 49.1% female; mean BMI 25.7 ± 4.4 kg/m2), in which 92 Catalyft™ spacers were implanted, mostly at L4/5 (n = 35; 38.0%) and L5/S1 (n = 31; 33.7%) for degenerative (n = 44; 83.0%), deformity (n = 7; 13.2%) or other indications (n = 2; 3.8%). We noticed secondary collapse of 20 (21.7%) spacers in 11 patients (20.7%) occurring after a mean time of 4.0 ± 4.1 months postoperatively. Age < 70 years was identified as risk factor for secondary collapse (OR 3.71, 95% CI 1.31-10.5, p = 0.014), but no association was found regarding other patient-specific or surgery-related variables. Pseudarthrosis was evident in seven patients (13.2%), of which four (7.6%) required revision surgery. Clinical outcome at last follow-up (mean 6.4 ± 4.2 months) was excellent/good in 29 (54.7%), fair in 14 (26.4%) and poor in six patients (11.3%). CONCLUSION We provide a critical analysis of our series of patients with use of a specific type of expandable interbody spacer. We noticed failure and secondary collapse in an unacceptably high number of implants, some of which required revision surgery.
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Affiliation(s)
- Nader Hejrati
- Spine Center of Eastern Switzerland, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland
- Department of Neurosurgery, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland
| | - Benjamin Martens
- Spine Center of Eastern Switzerland, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland
- Department of Orthopaedics and Traumatology, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, St. Gallen, Switzerland
| | - Bernhard Jost
- Spine Center of Eastern Switzerland, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland
- Department of Orthopaedics and Traumatology, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, St. Gallen, Switzerland
| | - Oliver Bozinov
- Spine Center of Eastern Switzerland, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland
- Department of Neurosurgery, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland
| | - Martin N Stienen
- Spine Center of Eastern Switzerland, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland.
- Department of Neurosurgery, Cantonal Hospital of St. Gallen & Medical School of St. Gallen, Rorschacher Str. 95, St. Gallen, CH-9007, Switzerland.
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Lee SB, Yoon J, Park SJ, Chae DS. Expandable Cages for Lumbar Interbody Fusion: A Narrative Review. J Clin Med 2024; 13:2889. [PMID: 38792431 PMCID: PMC11122612 DOI: 10.3390/jcm13102889] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2024] [Revised: 04/26/2024] [Accepted: 05/02/2024] [Indexed: 05/26/2024] Open
Abstract
Lumbar fusion surgery for treating degenerative spinal diseases has undergone significant advancements in recent years. In addition to posterior instrumentation, anterior interbody fusion techniques have been developed along with various cages for interbody fusion. Recently, expandable cages capable of altering height, lordotic angle, and footprint within the disc space have garnered significant attention. In this manuscript, we review the current status, clinical outcomes, and future prospects of expandable cages for lumbar interbody fusion based on the existing literature. Expandable cages are suitable for minimally invasive spinal surgeries. Small-sized cages can be inserted and subsequently expanded to a larger size within the disc space. While expandable cages generally demonstrate superior clinical outcomes compared to static cages, some studies have suggested comparable or even poorer outcomes with expandable cages than static cages. Careful interpretation through additional long-term follow-ups is required to assess the utility of expandable cages. If these shortcomings are addressed and the advantages are further developed, expandable cages could become suitable surgical instruments for minimally invasive spinal surgeries.
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Affiliation(s)
- Soo-Bin Lee
- Department of Orthopedic Surgery, Catholic Kwandong University International St. Mary’s Hospital, Incheon 22711, Republic of Korea;
| | - Jonghun Yoon
- Department of Mechanical Engineering, Hanyang University, Ansan 15588, Republic of Korea
| | - Sung-Jun Park
- School of Mechanical, Automotive and Aeronautical Engineering, Korea National University of Transportation, Chungju 27469, Republic of Korea
| | - Dong-Sik Chae
- Department of Orthopedic Surgery, Catholic Kwandong University International St. Mary’s Hospital, Incheon 22711, Republic of Korea;
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Newsom ET, Sadeghpour A, Entezari A, Vinzons JLU, Stanford RE, Mirkhalaf M, Chon D, Dunstan CR, Zreiqat H. Design and evaluation of 3D-printed Sr-HT-Gahnite bioceramic for FDA regulatory submission: A Good Laboratory Practice sheep study. Acta Biomater 2023; 156:214-221. [PMID: 35063706 DOI: 10.1016/j.actbio.2022.01.035] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2021] [Revised: 12/13/2021] [Accepted: 01/14/2022] [Indexed: 01/18/2023]
Abstract
There is an unmet clinical need for a spinal fusion implant material that recapitulates the biological and mechanical performance of natural bone. We have developed a bioceramic, Sr-HT-Gahnite, which has been identified as a potential fusion device material. This material has the capacity to transform the future of the global interbody devices market, with follow on social, economic, and environmental benefits, rooted in its remarkable combination of mechanical properties and bioactivity. In this study, and in line with FDA requirements, the in vivo preclinical systemic biological safety of a Sr-HT-Gahnite interbody fusion device is assessed over 26 weeks in sheep under good laboratory practice (GLP). Following the in-life phase, animals are assessed for systemic biological effects via blood haematology and clinical biochemistry, strontium dosage analysis in the blood and wool, and histopathology examination of the distant organs including adrenals, brain, heart, kidneys, liver, lungs and bronchi, skeletal muscle, spinal nerves close to the implanted sites, ovaries, and draining lymph nodes. Our results show that no major changes in blood haematology or biochemistry parameters are observed, no systemic distribution of strontium to the blood and wool, and no macroscopic or histopathological abnormalities in the distant organs when Sr-HT-Gahnite was implanted, compared to baseline and control values. Together, these results indicate the systemic safety of the Sr-HT-Gahnite interbody fusion device. The results of this study extend to the systemic safety of other Sr-HT-Gahnite implanted medical devices in contact with bone or tissue, of similar size and manufactured using the described processes. STATEMENT OF SIGNIFICANCE: This paper is considered original and innovative as it is the first that thoroughly reports the systemic biological safety of previously undescribed bioceramic material, Sr-HT-Gahnite. The study has been performed under good laboratory practice, in line with FDA requirements for assessment of a new interbody fusion device, making the results broadly applicable to the translation of sheep models to the human cervical spine; and also the translation of Sr-HT-Gahnite as a biomaterial for use in additional applications. We expect this study to be of broad interest to the readership of Acta Biomaterilia. Its findings are directly applicable to researchers and clinicians working in bone repair and the development of synthetic biomaterials.
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Affiliation(s)
- Ellen T Newsom
- Allegra Orthopaedics, 18-20 Orion Rd, Lane Cove West, NSW, 2066, Australia; Biomaterials and Tissue Engineering Research Unit, School of Biomedical Engineering, The University of Sydney, NSW, 2006, Australia
| | - Ameneh Sadeghpour
- Allegra Orthopaedics, 18-20 Orion Rd, Lane Cove West, NSW, 2066, Australia
| | - Ali Entezari
- Allegra Orthopaedics, 18-20 Orion Rd, Lane Cove West, NSW, 2066, Australia; Biomaterials and Tissue Engineering Research Unit, School of Biomedical Engineering, The University of Sydney, NSW, 2006, Australia
| | | | - Ralph E Stanford
- Faculty of Medicine, University of New South Wales, NSW, 2052, Australia
| | - Mohammad Mirkhalaf
- Biomaterials and Tissue Engineering Research Unit, School of Biomedical Engineering, The University of Sydney, NSW, 2006, Australia; Australian Research Council Training Centre for Innovative Bioengineering, Sydney, NSW, 2006, Australia
| | - Daniel Chon
- CTL Amedica, 4550 Excel Pkwy #300, Addison, TX, 75001, United States
| | - Colin R Dunstan
- Biomaterials and Tissue Engineering Research Unit, School of Biomedical Engineering, The University of Sydney, NSW, 2006, Australia; Australian Research Council Training Centre for Innovative Bioengineering, Sydney, NSW, 2006, Australia
| | - Hala Zreiqat
- Biomaterials and Tissue Engineering Research Unit, School of Biomedical Engineering, The University of Sydney, NSW, 2006, Australia; Australian Research Council Training Centre for Innovative Bioengineering, Sydney, NSW, 2006, Australia.
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Zheng Z, Liu P, Zhang X, Jingguo xin, Yongjie wang, Zou X, Mei X, Zhang S, Zhang S. Strategies to improve bioactive and antibacterial properties of polyetheretherketone (PEEK) for use as orthopedic implants. Mater Today Bio 2022; 16:100402. [PMID: 36105676 PMCID: PMC9466655 DOI: 10.1016/j.mtbio.2022.100402] [Citation(s) in RCA: 38] [Impact Index Per Article: 12.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2022] [Revised: 08/11/2022] [Accepted: 08/12/2022] [Indexed: 12/26/2022] Open
Abstract
Polyetheretherketone (PEEK) has gradually become the mainstream material for preparing orthopedic implants due to its similar elastic modulus to human bone, high strength, excellent wear resistance, radiolucency, and biocompatibility. Since the 1990s, PEEK has increasingly been used in orthopedics. Yet, the widespread application of PEEK is limited by its bio-inertness, hydrophobicity, and susceptibility to microbial infections. Further enhancing the osteogenic properties of PEEK-based implants remains a difficult task. This article reviews some modification methods of PEEK in the last five years, including surface modification of PEEK or incorporating materials into the PEEK matrix. For surface modification, PEEK can be modified by chemical treatment, physical treatment, or surface coating with bioactive substances. For PEEK composite material, adding bioactive filler into PEEK through the melting blending method or 3D printing technology can increase the biological activity of PEEK. In addition, some modification methods such as sulfonation treatment of PEEK or grafting antibacterial substances on PEEK can enhance the antibacterial performance of PEEK. These strategies aim to improve the bioactive and antibacterial properties of the modified PEEK. The researchers believe that these modifications could provide valuable guidance on the future design of PEEK orthopedic implants.
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Lewandrowski KU, Ferrara L, Cheng B. Expandable Interbody Fusion Cages: An Editorial on the Surgeon's Perspective on Recent Technological Advances and Their Biomechanical Implications. Int J Spine Surg 2020; 14:S56-S62. [PMID: 33122184 PMCID: PMC7735473 DOI: 10.14444/7127] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022] Open
Abstract
BACKGROUND Expandable cages have gone through several iterations since they first appeared on the market in the early 2000s. Their development was prompted by some common problems associated with static interbody cages, including migration, expulsion, dural or neural traction injury, and pseudarthrosis. OBJECTIVE To summarize current technological advances from earlier expandable lumbar interbody fusion devices to implants with vertical and medial-to-lateral expansion mechanisms. METHODS The authors review the currently available expandable cage designs, the incremental technological advances, and how these devices impact minimally invasive surgery interbody procedures and clinical outcomes. The strategic concepts intended to improve the minimally invasive application of expandable interbody fusion implants are reviewed from a surgeon's perspective in a clinical context to discuss how their use may improve patient outcomes. CONCLUSIONS The geometrical configuration, effective stiffness of composite multi-material cage designs may impact the bone-implant contact area with the endplates. Hybridization strategies of expandable cage technology with modern minimally invasive and endoscopic spinal surgery techniques are presented by outlining their advantages and disadvantages. LEVEL OF EVIDENCE 1 CLINICAL RELEVANCE: Systematic review.
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Affiliation(s)
- Kai-Uwe Lewandrowski
- Center for Advanced Spine Care of Southern Arizona and Surgical Institute of Tucson, Arizona, Department of Orthopaedics, Fundación Universitaria Sanitas, Bogotá, Colombia, Department of Neurosurgery, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, Brazil
| | - Lisa Ferrara
- OrthoKinetic Technologies LLC, Southport, North Carolina
| | - Boyle Cheng
- Carnegie Mellon University, Neurosurgical and Spine Research, Allegheny General Hospital, Pittsburgh, Pennsylvania
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Coric D, Roybal RR, Grubb M, Rossi V, Yu AK, Swink IR, Long J, Cheng BC, Inzana JA. Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance. Int J Spine Surg 2020; 14:S22-S30. [PMID: 33122186 DOI: 10.14444/7123] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
BACKGROUND Expandable devices for transforaminal or posterior lumbar interbody fusion (TLIF and PLIF, respectively) may enable greater restoration of disc height, foraminal height, and stability within the interbody space than static spacers. Medial-lateral expansion may also increase stability and resistance to subsidence. This study evaluates the clinical and radiographic outcomes from early experience with a bidirectional expandable device. METHODS This was a retrospective analysis of a continuous series of patients across 3 sites who had previously undergone TLIF or PLIF surgery with a bidirectional expandable interbody fusion device (FlareHawk, Integrity Implants, Inc) at 1 or 2 contiguous levels between L2 and S1. Outcomes included the Oswestry Disability Index (ODI), a visual analog scale (VAS) for back pain or leg pain, radiographic fusion by 1 year of follow-up, subsidence, device migration, and adverse events (AE). RESULTS There were 58 eligible patients with radiographs for 1-year fusion assessments and 45 patients with ODI, VAS back pain, or VAS leg pain data at baseline and a mean follow-up of 4.5 months. The ODI, VAS back pain, and VAS leg pain scores improved significantly from baseline to final follow-up, with mean improvements of 14.6 ± 19.1, 3.4 ± 2.6, and 3.9 ± 3.4 points (P < .001 for each), respectively. In addition, 58% of patients achieved clinically significant improvements in ODI, 76% in VAS back pain, and 71% in VAS leg pain. By 1 year, 96.6% of patients and 97.4% of levels were considered fused. There were zero cases of device subsidence and 1 case of device migration (1.7%). There were zero device-related AEs, 1 intraoperative dural tear, and 3 subsequent surgical interventions. CONCLUSIONS The fusion rate, improvements in patient-reported outcomes, and the AEs observed are consistent with those of other devices. The bidirectional expansion mechanism may provide other important clinical value, but further studies will be required to elucidate the unique advantages. LEVEL OF EVIDENCE 4.
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Affiliation(s)
- Domagoj Coric
- Carolina Neurosurgery & Spine Associates, Atrium Musculoskeletal Institute, Charlotte, North Carolina
| | | | - Mark Grubb
- Northeast Ohio Spine Center, Akron, Ohio
| | - Vincent Rossi
- Carolina Neurosurgery & Spine Associates, Atrium Musculoskeletal Institute, Charlotte, North Carolina
| | - Alex K Yu
- Neuroscience Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
| | - Isaac R Swink
- Neuroscience Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
| | - Jason Long
- Department of Radiology, Allegheny Health Network, Pittsburgh, Pennsylvania
| | - Boyle C Cheng
- Neuroscience Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
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Park S, Lee DH, Seo J, Kim KJ, Lee SK, Park JH, Cho JH, Park JW, Hwang CJ, Yang JJ, Lee CS. Feasibility of CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic Cage in Anterior Cervical Diskectomy and Fusion. World Neurosurg 2020; 141:e358-e366. [DOI: 10.1016/j.wneu.2020.05.143] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/05/2020] [Revised: 05/13/2020] [Accepted: 05/15/2020] [Indexed: 10/24/2022]
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朱 广, 镐 英, 于 磊, 彭 诚, 朱 剑, 张 盼. [Comparison of the effectiveness of oblique lumbar interbody fusion and posterior lumbar interbody fusion for treatment of Cage dislodgement after lumbar surgery]. ZHONGGUO XIU FU CHONG JIAN WAI KE ZA ZHI = ZHONGGUO XIUFU CHONGJIAN WAIKE ZAZHI = CHINESE JOURNAL OF REPARATIVE AND RECONSTRUCTIVE SURGERY 2020; 34:761-768. [PMID: 32538569 PMCID: PMC8171529 DOI: 10.7507/1002-1892.201911020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 11/04/2019] [Revised: 03/18/2020] [Indexed: 11/03/2022]
Abstract
OBJECTIVE To compare the clinical and radiological effectiveness of oblique lumbar interbody fusion (OLIF) and posterior lumbar interbody fusion (PLIF) in the treatment of Cage dislodgement after lumbar surgery. METHODS The clinical data of 40 patients who underwent revision surgery due to Cage dislodgement after lumbar surgery betweem April 2013 and March 2017 were retrospectively analyzed. Among them, 18 patients underwent OLIF (OLIF group) and 22 patients underwent PLIF (PLIF group) for revision. There was no significant difference between the two groups in age, gender, body mass index, intervals between primary surgery and revision surgery, number of primary fused levels, disc spaces of Cage dislodgement, and visual analogue scale (VAS) scores of low back pain and leg pain, Oswestry disability index (ODI), the segmental lordosis (SL) and disc height (DH) of the disc space of Cage dislodgement, and the lumbar lordosis (LL) before revision ( P>0.05). The operation time, intraoperative blood loss, hospital stay, and complications of the two groups were recorded and compared. The VAS scores of low back pain and leg pain were evaluated at 3 days, 3, 6, and 12 months after operation, and the ODI scores were evaluated at 3, 6, and 12 months after operation. The SL and DH of the disc space of Cage dislodgement and LL were measured at 12 months after operation and compared with those before operation. CT examination was performed at 12 months after operation, and the fusion of the disc space implanted with new Cage was judged by Bridwell grading standard. RESULTS The intraoperative blood loss in the OLIF group was significantly less than that in the PLIF group ( t=-12.425, P=0.000); there was no significant difference between the two groups in the operation time and hospital stay ( P>0.05). Both groups were followed up 12-30 months, with an average of 18 months. In the OLIF group, 2 patients (11.1%) had thigh numbness and 1 patient (5.6%) had hip flexor weakness after operation; 2 patients (9.1%) in the PLIF group had intraoperative dural sac tear. The other patients' incisions healed by first intention without early postoperative complications. There was no significant difference in the incidence of complications between the two groups ( χ 2=0.519, P=0.642). The VAS scores of low back pain and leg pain, and the ODI score of the two groups at each time point after operation were significantly improved when compared with those before operation ( P<0.05); there was no significant difference between the two groups at each time point after operation ( P>0.05). At 12 months after operation, SL, LL, and DH in the two groups were significantly increased when compared with preoperative ones ( P<0.05); SL and DH in the OLIF group were significantly improved when compared with those in the PLIF group ( P<0.05), and there was no significant difference in LL between the two groups ( P>0.05). CT examination at 12 months after operation showed that all the operated disc spaces achieved bony fusion. According to the Bridwell grading standard, 12 cases were grade Ⅰ and 6 cases were grade Ⅱ in the OLIF group, and 13 cases were grade Ⅰ and 9 cases were grade Ⅱ in the PLIF group; there was no significant difference between the two groups ( Z=-0.486, P=0.627). During follow-up, neither re-displacement or sinking of Cage, nor loosening or fracture of internal fixation occurred. CONCLUSION OLIF and PLIF can achieve similar effectiveness in the treatment of Cage dislodgement after lumbar surgery. OLIF can further reduce intraoperative blood loss and restore the SL and DH of the disc space of Cage dislodgement better.
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Affiliation(s)
- 广铎 朱
- 郑州大学第一附属医院骨科（郑州 450052）Department of Orthopedics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou Henan, 450052, P.R.China
| | - 英杰 镐
- 郑州大学第一附属医院骨科（郑州 450052）Department of Orthopedics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou Henan, 450052, P.R.China
| | - 磊 于
- 郑州大学第一附属医院骨科（郑州 450052）Department of Orthopedics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou Henan, 450052, P.R.China
| | - 诚 彭
- 郑州大学第一附属医院骨科（郑州 450052）Department of Orthopedics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou Henan, 450052, P.R.China
| | - 剑 朱
- 郑州大学第一附属医院骨科（郑州 450052）Department of Orthopedics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou Henan, 450052, P.R.China
| | - 盼可 张
- 郑州大学第一附属医院骨科（郑州 450052）Department of Orthopedics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou Henan, 450052, P.R.China
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Kyle A, Rowland A, Stirton J, Elgafy H. Fracture of allograft interbody spacer resulting in post-operative radiculopathy: A case report. World J Orthop 2019; 10:206-211. [PMID: 31041162 PMCID: PMC6475813 DOI: 10.5312/wjo.v10.i4.206] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/02/2019] [Revised: 02/18/2019] [Accepted: 03/16/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Allograft interbody spacers are utilized during transforaminal lumbar interbody fusion (TLIF) to reestablish anterior column support and disc height. While the TLIF technique offers many improvements over previous surgical methods, instrumentation and bone graft-related complications such as spacer misplacement or migration, screw fracture or misplacement, or rod breakage continue to be reported. The objective of this manuscript is to report on a fractured allograft interbody spacer that displaced into the neural foramen and resulted in impingement on the exiting nerve root that required revision. CASE SUMMARY A 50-year-old male had two-level TLIF with immediate post-operative right L5 radiculopathy. Computed tomography scan demonstrated a fractured allograft interbody spacer that displaced into the right neural foramen and impinged on the exiting L5 nerve root. Revision surgery was performed to remove the broken allograft fragments from the right L5 foramen and the intact portion of the spacer was left in place. The right leg L5 radicular pain resolved. At the last follow up 12 mo after the index procedure, computed tomography scan confirmed sound interbody and posterolateral fusion. CONCLUSION Displacement of broken allograft interbody spacer following TLIF procedures can result in neurological sequelae that require revision. To avoid such an occurrence, the authors recommend allowing sufficient time for the reconstitution of the graft in saline prior to use to decrease brittleness, to use an impactor size that is as close as possible to the spacer size and meticulous inspection of the cortical allograft spacer for any visible imperfection prior to insertion.
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Affiliation(s)
- Andrews Kyle
- Department of Orthopaedic Surgery, University of Toledo College of Medicine and Life Sciences, 3000 Arlington Avenue, Toledo, OH 43614-5807, United States
| | - Andrea Rowland
- Department of Orthopaedic Surgery, University of Toledo College of Medicine and Life Sciences, 3000 Arlington Avenue, Toledo, OH 43614-5807, United States
| | - Jacob Stirton
- Department of Orthopaedic Surgery, University of Toledo College of Medicine and Life Sciences, 3000 Arlington Avenue, Toledo, OH 43614-5807, United States
| | - Hossein Elgafy
- Department of Orthopaedic Surgery, University of Toledo College of Medicine and Life Sciences, 3000 Arlington Avenue, Toledo, OH 43614-5807, United States
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Johansson P, Jimbo R, Kozai Y, Sakurai T, Kjellin P, Currie F, Wennerberg A. Nanosized Hydroxyapatite Coating on PEEK Implants Enhances Early Bone Formation: A Histological and Three-Dimensional Investigation in Rabbit Bone. MATERIALS 2015; 8:3815-3830. [PMID: 28793409 PMCID: PMC5455651 DOI: 10.3390/ma8073815] [Citation(s) in RCA: 40] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/24/2015] [Revised: 06/04/2015] [Accepted: 06/17/2015] [Indexed: 11/16/2022]
Abstract
Polyether ether ketone (PEEK) has been frequently used in spinal surgery with good clinical results. The material has a low elastic modulus and is radiolucent. However, in oral implantology PEEK has displayed inferior ability to osseointegrate compared to titanium materials. One idea to reinforce PEEK would be to coat it with hydroxyapatite (HA), a ceramic material of good biocompatibility. In the present study we analyzed HA-coated PEEK tibial implants via histology and radiography when following up at 3 and 12 weeks. Of the 48 implants, 24 were HA-coated PEEK screws (test) and another 24 implants served as uncoated PEEK controls. HA-coated PEEK implants were always osseointegrated. The total bone area (BA) was higher for test compared to control implants at 3 (p < 0.05) and 12 weeks (p < 0.05). Mean bone implant contact (BIC) percentage was significantly higher (p = 0.024) for the test compared to control implants at 3 weeks and higher without statistical significance at 12 weeks. The effect of HA-coating was concluded to be significant with respect to early bone formation, and HA-coated PEEK implants may represent a good material to serve as bone anchored clinical devices.
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Affiliation(s)
- Pär Johansson
- Department of Prostodontics, Faculty of Odontology, Malmö University, Malmö S-214 21, Sweden.
| | - Ryo Jimbo
- Department of Prostodontics, Faculty of Odontology, Malmö University, Malmö S-214 21, Sweden.
| | - Yusuke Kozai
- Department of Radiopraxis Science, Kanagawa Dental University, Yokosuka, Kanagawa Prefecture 238-8580, Japan.
| | - Takashi Sakurai
- Department of Radiopraxis Science, Kanagawa Dental University, Yokosuka, Kanagawa Prefecture 238-8580, Japan.
| | - Per Kjellin
- Promimic AB, Stena Center 1B, Göteborg S-412 92, Sweden.
| | - Fredrik Currie
- Promimic AB, Stena Center 1B, Göteborg S-412 92, Sweden.
| | - Ann Wennerberg
- Department of Prostodontics, Faculty of Odontology, Malmö University, Malmö S-214 21, Sweden.
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Kersten RFMR, van Gaalen SM, de Gast A, Öner FC. Polyetheretherketone (PEEK) cages in cervical applications: a systematic review. Spine J 2015; 15:1446-60. [PMID: 24374100 DOI: 10.1016/j.spinee.2013.08.030] [Citation(s) in RCA: 106] [Impact Index Per Article: 10.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2013] [Revised: 07/22/2013] [Accepted: 08/23/2013] [Indexed: 02/03/2023]
Abstract
BACKGROUND CONTEXT Polyetheretherketone (PEEK) cages have been widely used during the past decade in patients with degenerative disorders of the cervical spine. Their radiolucency and low elastic modulus make them attractive attributes for spinal fusion compared with titanium and bone graft. Still, limitations are seen such as pseudoarthrosis, subsidence, and migration of the cages. Limited evidence on the clinical outcome of PEEK cages is found in the literature other than noncomparative cohort studies with only a few randomized controlled trials. PURPOSE To assess the clinical and radiographic outcome of PEEK cages in the treatment of degenerative disc disorders and/or spondylolisthesis in the cervical spine. STUDY DESIGN Systematic review of all randomized controlled trials and prospective and retrospective nonrandomized comparative studies with a minimum follow-up of 6 months and all noncomparative cohort studies with a long-term follow-up of more than 5 years. OUTCOME MEASURES The primary outcome variable was clinical performance. Secondary outcome variables consisted of radiographic scores. METHODS The MEDLINE, EMBASE, and Cochrane Library databases were searched according to the Preferred Reporting Items of Systematic reviews and Meta-Analyses statement and Meta-analysis Of Observational Studies in Epidemiology guidelines. No conflict of interest reported. No funding received. RESULTS A total of 223 studies were identified, of which 10 studies were included. These comprised two randomized controlled trials, five prospective comparative trials, and three retrospective comparative trials. CONCLUSIONS Minimal evidence for better clinical and radiographic outcome is found for PEEK cages compared with bone grafts in the cervical spine. No differences were found between PEEK, titanium, and carbon fiber cages. Future studies are needed to improve methodology to minimize bias. Publication of lumbar interbody fusion studies needs to be promoted because differences in clinical and/or radiographic scores are more likely to be demonstrated in this part of the spine.
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Affiliation(s)
- Roel Frederik Mark Raymond Kersten
- Department of Orthopaedics, Clinical Orthopaedic Research Center midden-Nederland (CORC-mN), Diakonessenhuis Hospital Utrecht/Zeist, PO Box 80250, 3508 TG Utrecht, The Netherlands.
| | - Steven M van Gaalen
- Department of Orthopaedics, Clinical Orthopaedic Research Center midden-Nederland (CORC-mN), Diakonessenhuis Hospital Utrecht/Zeist, PO Box 80250, 3508 TG Utrecht, The Netherlands
| | - Arthur de Gast
- Department of Orthopaedics, Clinical Orthopaedic Research Center midden-Nederland (CORC-mN), Diakonessenhuis Hospital Utrecht/Zeist, PO Box 80250, 3508 TG Utrecht, The Netherlands
| | - F Cumhur Öner
- Department of Orthopaedics, University Medical Center Utrecht, Utrecht, The Netherlands
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Luo J, Huang S, Gong M, Li L, Yu T, Zou X. Two-level anterior cervical discectomy and fusion using self-locking stand-alone polyetheretherketone cages with two anchoring clips placed in the upper and lower vertebrae, respectively. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY 2015; 25 Suppl 1:S147-53. [PMID: 25733346 DOI: 10.1007/s00590-015-1613-6] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/19/2014] [Accepted: 02/23/2015] [Indexed: 10/23/2022]
Abstract
BACKGROUND Anterior cervical discectomy and fusion (ACDF) is a widely accepted surgical procedure for the treatment of cervical degenerative disk diseases (CDDD). The purpose of our study was to investigate the reliability and efficacy of ACDF using self-locking stand-alone polyetheretherketone (PEEK) cages, with two anchoring clips placed in the upper and lower vertebrae, respectively. METHODS AND MATERIALS Twenty-six patients who underwent ACDF using a stand-alone PEEK cage packed with local osteophytes and cancellous allograft bone from January 2010 to January 2012 were enrolled in this study. Clinical findings were assessed using a visual analog scale (VAS), Japanese Orthopaedic Association (JOA) score, neck disability index (NDI), and Odom criteria. Intervertebral height and cervical fusion status were assessed on X-ray. RESULTS Twenty-six patients underwent ACDF using a stand-alone PEEK cervical cage. All patients had a minimum 2 years of follow-up. The operative levels were C3/4, C4/5 in seven patients, C4/5, C5/6 in 13 patients, and C4/5, C6/7 in six patients. At 3 days, 6 months, and 2 years of follow-ups, the JOA scores were 10.41 ± 1.67, 13.78 ± 1.91, 14.42 ± 2.09, respectively, which was significantly higher (p < 0.01) than preoperative (7.34 ± 1.71), whereas VAS overall pain score was 4.35 ± 1.32, 1.73 ± 0.44, 1.32 ± 0.57, respectively, which was significantly lower (p < 0.01) than preoperative (8.01 ± 1.16). The NDI preoperatively was 33.94 ± 11.75, 23.53 ± 10.92 at 3 days postoperatively, 12.64 ± 8.36 at 6 months, and 10.74 ± 7.92 at 2 years of follow-ups. Intervertebral height was 5.99 ± 0.31 mm preoperatively, 8.70 ± 0.23 mm at 3 days, 8.34 ± 0.61 mm at 6 months, and 8.22 ± 0.35 mm at 2 years of follow-ups. According to Odom criteria, 10 patients (38.4%) presented with an excellent clinical outcome, 15 good (57.6%), 1 fair (3.8%), and no patient presented a poor outcome. Solid fusion was achieved in all patients (100%) at a mean time of 4.5 months. CONCLUSION ACDF using a self-locking stand-alone PEEK cage with two anchoring clips placed in the upper and lower vertebrae, respectively, could be considered a safe and effective substitute for fusion in patients with two-level CDDD; it can effectively restore the intervertebral height, facilitate radiologic follow-up, cause few complications, and lead to satisfactory outcomes.
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Affiliation(s)
- Jiaquan Luo
- Department of Spine Surgery/Orthopaedic Research Institute, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510080, People's Republic of China,
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Leute PJF, Hammad A, Hoffmann I, Hoppe S, Klinger HM, Lakemeier S. Set screw fracture with cage dislocation after two-level transforaminal lumbar interbody fusion (TLIF): a case report. J Med Case Rep 2015; 9:22. [PMID: 25609204 PMCID: PMC4333885 DOI: 10.1186/1752-1947-9-22] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2014] [Accepted: 12/10/2014] [Indexed: 12/11/2022] Open
Abstract
Introduction Transforaminal lumbar interbody fusion is a popular procedure used to achieve spondylodesis in patients with degenerative lumbar spinal diseases. We present a rare case of a patient with a set screw fracture with cage dislocation after an open transforaminal lumbar interbody fusion procedure. To the best of our knowledge, this case is the first of its kind to be reported. Case presentation A 44-year-old Caucasian woman attended a follow-up appointment at our hospital 3 months after treatment for second-degree lumbar spondylolisthesis (L4/L5) and osteochondrosis (L5/S1) with transforaminal lumbar interbody fusion and dorsal spondylodesis. She complained of severe leg pain on the left side. Her physical examination revealed a normal neurological status, except for paresthesia of the entire left lower limb and at the ball of the left foot. Radiological imaging showed breaking of the set screws with cage dislocation. Surgical revision was then performed with exchange of the whole dorsal instrumentation and the dislocated cage. Six weeks post-operatively, the patient was seen again at our clinic without neurological complaints, except for decreased sensitivity on the dorsum of her left foot. The wound healing and radiological follow-up were uneventful. Conclusions Hardware-related complications are rarely seen in patients with open transforaminal lumbar interbody fusion, but must be kept in mind and can potentially cause severe neurological deficits.
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Stein IC, Than KD, Chen KS, Wang AC, Park P. Failure of a polyether-ether-ketone expandable interbody cage following transforaminal lumbar interbody fusion. 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 2014; 24 Suppl 4:S555-9. [PMID: 25465905 DOI: 10.1007/s00586-014-3704-1] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/03/2014] [Revised: 11/24/2014] [Accepted: 11/26/2014] [Indexed: 12/28/2022]
Abstract
PURPOSE Expandable cages are a more recent option for maintaining or restoring disc height and segmental lordosis with transforaminal lumbar interbody fusion (TLIF). Complications associated with expandable cages have not yet been widely reported. We report a case of postoperative failure of a polyether-ether-ketone (PEEK) expandable interbody device used during TLIF. METHODS A 50-year-old man presented with severe back and right leg pain after undergoing L4-5 and L5-S1 TLIFs with expandable cages and L3-S1 posterior instrumented fusion. Imaging showed retropulsion of a portion of the interbody cage into the spinal canal causing nerve compression. Displacement occurred in a delayed manner. In addition, pseudoarthrosis was present. RESULTS The patient underwent re-exploration with removal of the retropulsed wafer and redo fusion. CONCLUSIONS Expandable cages are a recent innovation; as such, efficacy and complication data are limited. As with any new device, there exists potential for mechanical failure, as occurred in the case presented.
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Affiliation(s)
- Isaac C Stein
- University of Michigan Medical School, Ann Arbor, MI, USA
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Tumialán LM, Clark JC, Snyder LA, Marciano FF. Provisional ipsilateral expandable rod for disc space distraction in minimally invasive transforaminal lumbar interbody fusion: operative technique. Neurosurgery 2014; 10 Suppl 4:555-64; discussion 564. [PMID: 25161005 DOI: 10.1227/neu.0000000000000542] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022] Open
Abstract
BACKGROUND Lumbar disc degeneration may be so advanced and asymmetrical that transforaminal access to the interbody space is limited. The extent of collapse may compromise the capacity to restore disc height and coronal balance in minimally invasive approaches. Although a variety of distractors are available for open approaches, currently there is no feasible distractor that is functional within a minimally invasive retractor. OBJECTIVE To describe the development of a provisional ipsilateral expandable rod for use in minimally invasive surgery for transforaminal lumbar interbody fusions to optimize access to the disc space, thereby facilitating placement of an interbody spacer. METHODS The authors report the clinical and radiographic data for 30 patients (3 open and 27 minimally invasive surgeries) with advanced degenerative disc disease in whom a provisional ipsilateral expandable rod was used to restore coronal balance and maintain disc height for interbody preparation and placement. Preoperative disc heights were measured, and the height of interbody spacer recorded. Mean restoration of disc heights was calculated. RESULTS The provisional ipsilateral expandable rod was successfully applied in both open exposures and within a minimally invasive retractor. The mean preoperative disc height was 4.9 mm (range, 1-9 mm), the mean height of the spacer inserted was 11.1 mm (range, 8-15 mm), and the mean increase in disc height was 6.2 mm (range, 5-11 mm). CONCLUSION A provisional ipsilateral expandable rod is feasible in either minimally invasive or open approaches. It has the capacity to maintain the disc height achieved by paddle distractors. This facilitates both the disc preparation and optimizes restoration of disc height and interbody spacer placement.
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Affiliation(s)
- Luis M Tumialán
- *Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona; ‡Division of Neurological Surgery, Scottsdale Healthcare System, Scottsdale, Arizona
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Kersten RFMR, van Gaalen SM, Arts MP, Roes KCB, de Gast A, Corbin TP, Öner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord 2014; 15:57. [PMID: 24568365 PMCID: PMC3937453 DOI: 10.1186/1471-2474-15-57] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2013] [Accepted: 02/18/2014] [Indexed: 11/23/2022] Open
Abstract
Background Polyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion. Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages. Methods/Design This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18–75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists. Discussion In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders. Trial registration NCT01557829
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Affiliation(s)
- Roel F M R Kersten
- Clinical Orthopaedic Research Center-midden Nederland (CORC-mN), Department of Orthopaedics, Diakonessenhuis, Utrecht/Zeist, The Netherlands.
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Gonzalez-Blohm SA, Doulgeris JJ, Aghayev K, Lee WE, Laun J, Vrionis FD. In vitro evaluation of a lateral expandable cage and its comparison with a static device for lumbar interbody fusion: a biomechanical investigation. J Neurosurg Spine 2014; 20:387-95. [PMID: 24484306 DOI: 10.3171/2013.12.spine13798] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
OBJECT Through in vitro biomechanical testing, the authors compared the performance of a vertically expandable lateral lumbar interbody cage (EC) under two different torque-controlled expansions (1.5 and 3.0 Nm) and with respect to an equivalent lateral lumbar static cage (SC) with and without pedicle screw fixation. METHODS Eleven cadaveric human L2-3 segments were evaluated under the following conditions: 1) intact; 2) discectomy; 3) EC under 1.50 Nm of torque expansion (EC-1.5Nm); 4) EC under 3.00 Nm of torque expansion (EC-3.0Nm); 5) SC; and 6) SC with a bilateral pedicle screw system (SC+BPSS). Load-displacement behavior was evaluated for each condition using a combination of 100 N of axial preload and 7.5 Nm of torque in flexion and extension (FE), lateral bending (LB), and axial rotation (AR). Range of motion (ROM), neutral zone stiffness (NZS), and elastic zone stiffness (EZS) were statistically compared among conditions using post hoc Wilcoxon signed-rank comparisons after Friedman tests, with a significance level of 0.05. Additionally, any cage height difference between interbody devices was evaluated. When radiographic subsidence was observed, the specimen's data were not considered for the analysis. RESULTS The final cage height in the EC-1.5Nm condition (12.1 ± 0.9 mm) was smaller (p < 0.001) than that in the EC-3.0Nm (13.9 ± 1.1 mm) and SC (13.4 ± 0.8 mm) conditions. All instrumentation reduced (p < 0.01) ROM with respect to the injury and increased (p ≤ 0.01) NZS in flexion, extension, and LB as well as EZS in flexion, LB, and AR. When comparing the torque expansions, the EC-3.0Nm condition had smaller (p < 0.01) FE and AR ROM and greater (p ≤ 0.04) flexion NZS, extension EZS, and AR EZS. The SC condition performed equivalently (p ≥ 0.10) to both EC conditions in terms of ROM, NZS, and EZS, except for EZS in AR, in which a marginal (p = 0.05) difference was observed with respect to the EC-3.0Nm condition. The SC+BPSS was the most rigid construct in terms of ROM and stiffness, except for 1) LB ROM, in which it was comparable (p = 0.08) with that of the EC-1.5Nm condition; 2) AR NZS, in which it was comparable (p > 0.66, Friedman test) with that of all other constructs; and 3) AR EZS, in which it was comparable with that of the EC-1.5Nm (p = 0.56) and SC (p = 0.08) conditions. CONCLUSIONS A 3.0-Nm torque expansion of a lateral interbody cage provides greater immediate stability in FE and AR than a 1.5-Nm torque expansion. Moreover, the expandable device provides stability comparable with that of an equivalent (in size, shape, and bone-interface material) SC. Specifically, the SC+BPSS construct was the most stable in FE motion. Even though an EC may seem a better option given the minimal tissue disruption during its implantation, there may be a greater chance of endplate collapse by over-distracting the disc space because of the minimal haptic feedback from the expansion.
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Girasole G, Muro G, Mintz A, Chertoff J. Transforaminal lumbar interbody fusion rates in patients using a novel titanium implant and demineralized cancellous allograft bone sponge. Int J Spine Surg 2013; 7:e95-e100. [PMID: 25580378 PMCID: PMC4288454 DOI: 10.1016/j.ijsp.2013.08.001] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023] Open
Abstract
BACKGROUND Transforaminal lumbar interbody fusion (TLIF) with grafting and implant options like iliac crest bone graft (ICBG), recombinant bone morphogenetic protein (rhBMP), and polyetheretherketone (PEEK) cages have been reported to achieve extremely high fusion rates. Unfortunately, these options have also been frequently cited in the literature as causing postoperative morbidity and complications at a high cost. Knowing this, we sought to investigate TLIF using an acid-etched, roughened titanium cage that upregulates osteogenesis to see if similar fusion rates to those cited for ICBG, rhBMP, and PEEK cages could be safely achieved with minimal morbidity and complications. MATERIALS AND METHODS A radiographic fusion study of 82 patients who underwent TLIF using an acid-etched, roughened titanium cage with demineralized cancellous bone graft was conducted. Fusion was assessed and graded by an independent radiologist using computed tomography scan with sagittal and coronal reconstructions. RESULTS Fusion rates at 6 months were 41 of 44 (93.2%) and at 12 months were 37 of 38 (97.4%). There were no radiographic device-related complications. CONCLUSIONS TLIF with an acid-etched, roughened titanium cage filled with a decalcified bone graft achieved similar fusion rates to historical controls using ICBG, rhBMP, and PEEK.
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Affiliation(s)
- Gerard Girasole
- Orthopaedic and Sports Medical Center, Trumbull, CT
- Corresponding author: Gerad Girasole, MD, OSM 888 White plains Road, Trumbull, CT 06611. Tel.: +1-203-268-2882. E-mail address:
| | - Gerard Muro
- Orthopaedic and Sports Medical Center, Trumbull, CT
| | | | - Jason Chertoff
- Department of Internal Medicine, University of Florida College of Medicine, Gainesville, FL
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