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Chen M, Tang H, Shan J, Chen H, Jia P, Bao L, Feng F, Shi G, Wang R. A new interspinous process distraction device BacFuse in the treatment of lumbar spinal stenosis with 5 years follow-up study. Medicine (Baltimore) 2020; 99:e20925. [PMID: 32590804 PMCID: PMC7329017 DOI: 10.1097/md.0000000000020925] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
To explore a suitable indication of interspinous process distraction device for lumbar spinal stenosis with BacFuse.Patients of lumbar spinal stenosis (LSS) who experienced interspinous process distraction device surgery with BacFuse from June 2014 to January 2015 in our institute were included. We classified LSS into central and lateral types, and then divided these into severe and moderate according to the degree of stenosis. Each type was divided into 2 groups. Patients in group A underwent distraction without bone decompression (stand-alone), while patients in group B underwent bone decompression combined with distraction. Follow-up was performed at 1 month, 3 months, 6 months, 2 years, and 5 years after surgery. Zurich Claudication Questionnaire (ZCQ) was recorded to assess the patient's postoperative condition at each follow-up.A total of 142 patients were available for follow up at each time interval. There was a significant difference between the preoperative and final follow-up ZCQ scores for every LSS type. In addition, there was no difference between group A and group B in the postoperative ZCQ scores with the exception of the lateral severe type. In the study, 22 of the 23 patients (95.65%) in the lateral moderate type were considered to have a satisfactory result in group B, with a similar result of 93.33% (14/15) in group A (P = .75). In the lateral severe type, the patient satisfaction rate was 65.22% (15/23) and 90.63% (29/32) in group A and group B (P = .02), respectively. In the central moderate type, the patient satisfaction rate was 81.82% (15/23) and 76.92% (10/13) in group A and group B (P = .77), respectively. Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91). Moreover, no relationship was found between satisfaction and neurogenic intermittent claudication.The most suitable indication for BacFuse treatment was the lateral moderate type. For lateral severe patients, distraction combined with decompression is suggested for a higher satisfaction rate. Severe central spinal stenosis was shown to be a relative contraindication for BacFuse.
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Affiliation(s)
- Mengmeng Chen
- Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China
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Filippiadis DK, Marcia S, Ryan A, Beall DP, Masala S, Deschamps F, Kelekis A. New Implant-Based Technologies in the Spine. Cardiovasc Intervent Radiol 2018; 41:1463-1473. [DOI: 10.1007/s00270-018-1987-z] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/15/2017] [Accepted: 05/15/2018] [Indexed: 11/28/2022]
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Ravindra VM, Ghogawala Z. Is There Still a Role for Interspinous Spacers in the Management of Neurogenic Claudication? Neurosurg Clin N Am 2018; 28:321-330. [PMID: 28600006 DOI: 10.1016/j.nec.2017.02.002] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
Lumbar spinal stenosis with neurogenic claudication is prevalent in the elderly population. Decompression for this condition is the operation most commonly used to treat older patients. Because of the risks associated with open decompression procedures, particularly in older patients with comorbidities, minimally invasive procedures with implantation of interspinous process devices have been developed. This article reviews the current role of interspinous spacers in the treatment of lumbar spinal stenosis with neurogenic claudication and discusses the body of literature surrounding this treatment alternative.
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Affiliation(s)
- Vijay M Ravindra
- Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, 175 North Medical Drive East, Salt Lake City, UT 84132, USA; Department of Neurosurgery, Alan and Jacqueline Stuart Spine Research Center, Lahey Hospital and Medical Center, 41 Mall Road, Burlington, MA 01805, USA
| | - Zoher Ghogawala
- Department of Neurosurgery, Alan and Jacqueline Stuart Spine Research Center, Lahey Hospital and Medical Center, 41 Mall Road, Burlington, MA 01805, USA; Department of Neurosurgery, Tufts University School of Medicine, 145 Harrison Avenue, Boston, MA 02111, USA.
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Ramesh A, Lyons F, Kelleher M. Aperius interspinous device for degenerative lumbar spinal stenosis: a review. Neurosurg Rev 2015; 39:197-205; discussion 205. [PMID: 26324829 DOI: 10.1007/s10143-015-0664-9] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2014] [Accepted: 06/27/2015] [Indexed: 11/26/2022]
Abstract
With an aging population, degenerative lumbar spinal stenosis (DLSS) leading to neurogenic intermittent claudication (NIC) is a growing problem. For patients suffering from this condition, interspinous process distraction devices (IPDs) offer an effective and cheap alternative to conservative or decompressive surgery. Aperius is one such device that has been gaining popularity for its percutaneous insertion under local anesthetic, short operative time, and low risk of complications. The main objective of this review was to carry out a comprehensive search of the literature to evaluate the effectiveness and potential complications of Aperius. A database search, including PubMed, Clinical trials.gov, Cochrane (CENTRAL), MEDLINE, CINAHL, EMBASE, and Scopus, was carried out to identify relevant articles written in English reporting on complications with a minimum 12-month follow-up. The literature search resulted in six eligible studies; two nonrandomized comparative and four prospective case series were available. The analysis revealed that in total, 433 patients underwent treatment with Aperius, with all studies demonstrating an improvement in outcome measures. The average follow-up was 17 months with an overall complication rate of 10.62%. Overall, the quality of evidence is low, suggesting that currently, the evidence is not compelling and further prospective randomized trials including cost-effectiveness studies are required.
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Affiliation(s)
- Ashwanth Ramesh
- RCSI, Department of Anatomy, St. Stephens Green, Dublin 2, Ireland.
| | - Frank Lyons
- Cappagh National Orthopaedic Hospital, Dublin, Ireland
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Landi A. Interspinous posterior devices: What is the real surgical indication? World J Clin Cases 2014; 2:402-408. [PMID: 25232541 PMCID: PMC4163760 DOI: 10.12998/wjcc.v2.i9.402] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/10/2014] [Revised: 03/14/2014] [Accepted: 07/14/2014] [Indexed: 02/05/2023] Open
Abstract
Interspinous posterior device (IPD) is a term used to identify a relatively recent group of implants used to treat lumbar spinal degenerative disease. This kind of device is classified as part of the group of the dynamic stabilization systems of the spine. The concept of dynamic stabilization has been replaced by that of dynamic neutralization of hypermobility, with the intention of clarifying that the primary aim of this kind of system is not the preservation of the movement, but the dynamic neutralization of the segmental hypermobility which is at the root of the pathological condition. The indications for the implantation of an IPD are spinal stenosis and neurogenic claudication, assuming that its function is the enlargement of the neural foramen and the decompression of the roots forming the cauda equina in the central part of the vertebral canal. In the last 10 years, use of these implants has been very common but to date, no long-term clinical follow-up regarding clinical and radiological aspects are available. The high rate of reoperation, recurrence of symptoms and progression of degenerative changes is evident in the literature. If these devices are effectively a miracle cure for lumbar spinal stenosis, why do the utilization and implantation of IPD remain extremely controversial and should they be investigated further? Excluding the problems related to the high cost of the device, the main problem remains the pathological substrate on which the device is explicit in its action: the degenerative pathology of the spine.
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One-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device. BIOMED RESEARCH INTERNATIONAL 2014; 2014:176936. [PMID: 24822181 PMCID: PMC4009302 DOI: 10.1155/2014/176936] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/13/2014] [Accepted: 03/24/2014] [Indexed: 11/17/2022]
Abstract
PURPOSE New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). HeliFix is a minimally invasive IPD that can be implanted percutaneously. This is a preliminary evaluation of safety and effectiveness of this IPD up to 12 months after implantation. METHODS After percutaneous implantation in 100 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months. RESULTS Early symptoms and physical function improvements were maintained for up to 12 months. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 2% of patients due to lack of effectiveness. CONCLUSIONS Overall, in a period of up to 12-month follow-up, the safety and effectiveness of the HeliFix offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are undertaken in order to provide insight on outcomes and effectiveness compared to other decompression methods and to develop guidance on optimal patient selection.
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Loguidice V, Bini W, Shabat S, Miller LE, Block JE. Rationale, design and clinical performance of the Superion®Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices 2014; 8:419-26. [DOI: 10.1586/erd.11.24] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life. 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 2013; 22:2015-21. [PMID: 23625306 DOI: 10.1007/s00586-013-2790-9] [Citation(s) in RCA: 31] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/06/2012] [Revised: 03/21/2013] [Accepted: 04/18/2013] [Indexed: 10/26/2022]
Abstract
PURPOSE Percutaneous interspinous stand-alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication. Nonetheless, open decompressive surgery remains the standard of care. This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use. METHODS Forty-five patients were included in this open prospective non-randomized study, and treated either with percutaneous interspinous stand-alone spacers (Aperius(®)) or bilateral open microsurgical decompression at L3/4 or L4/5. Patient data, operative data, COMI, SF-36, PCS and MCS, ODI, and walking distance were collected 6 weeks, 3, 6, 9, 12, and 24 months post-surgery. RESULTS Group 1 (n = 12) underwent spacer implantation, group 2 (n = 33) open decompression. Five patients from group 1 required implant removal and open decompression during follow-up (FU); one patient was lost to FU. From group 2, seven patients were lost to FU. Remaining patients were assessed as above. After 2 years, back pain, leg pain, ODI, and quality of life improved significantly for group 2. Remaining group 1 patients (n = 6) reported worse results. Walking distance improved for both groups. CONCLUSION Decompression proved superior to percutaneous stand-alone spacer implantation in our two observational cohorts. Therapeutic failure was too high for interspinous spacers.
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Bonaldi G, Cianfoni A. Percutaneous treatment of lumbar compression fracture with canal stenosis and neurogenic intermittent claudication: combining kyphoplasty and interspinous spacer. J Vasc Interv Radiol 2013; 23:1437-41. [PMID: 23101915 DOI: 10.1016/j.jvir.2012.06.023] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2011] [Revised: 06/09/2012] [Accepted: 06/20/2012] [Indexed: 02/08/2023] Open
Abstract
Vertebral compression fractures (VCFs) can cause symptomatic spinal canal stenosis secondary to posterior wall retropulsion. This report describes four patients with VCF and lumbar stenosis secondary to posterior wall retropulsion who were treated with combined kyphoplasty and percutaneous interspinous spacer (IS) placement. Clinical and imaging follow-up ranged from 12-36 months. Outcomes were favorable. Combined kyphoplasty and percutaneous IS implant represents a minimally invasive, safe, and efficient option to treat VCF with symptomatic spinal stenosis.
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Affiliation(s)
- Giuseppe Bonaldi
- Department of Neuroradiology, Ospedali Riuniti di Bergamo, Largo Barozzi 1, 24128 Bergamo, Italy.
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Efficacy of an interspinous decompression device versus nonoperative treatment for lumbar spinal stenosis: an example for a randomized, controlled trial. ACTA ACUST UNITED AC 2012. [DOI: 10.4155/cli.12.128] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
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The interspinous spacer: a clinicoanatomical investigation using plastination. Minim Invasive Surg 2012; 2012:538697. [PMID: 22900164 PMCID: PMC3415215 DOI: 10.1155/2012/538697] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2012] [Accepted: 04/23/2012] [Indexed: 12/13/2022] Open
Abstract
Purpose. The relatively new and less-invasive therapeutic alternative "interspinous process decompression device (IPD)" is expected to result in improved symptoms of neurogenic intermittent claudication (NIC) caused by lumbar spinal stenosis. The aim of the study was to analyze IPD position particularly regarding damage originating from surgical implantation. Methods. Anatomic assessments were performed on a fresh human cadaver. For the anatomic examination, the lumbar spine was plastinated after implantation of the IPDs. After radiographic control, serial 4 mm thick sections of the block plastinate were cut in the sagittal (L1-L3) and horizontal (L3-L5) planes. The macroanatomical positioning of the implants was then analyzed. The insertion procedure caused only little injury to osteoligamentous or muscular structures. The supraspinous ligament was completely intact, and the interspinous ligaments were not torn as was initially presupposed. No osseous changes at the spinal processes were apparent. Contact of the IPD with the spinous processes was visible, so that sufficient biomechanical limitation of the spinal extension seems likely. Conclusions. Minimally invasive IPD implantation with accurate positioning in the anterior portion of the interspinous place is possible without severe surgical trauma.
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Van Meirhaeghe J, Fransen P, Morelli D, Craig NJA, Godde G, Mihalyi A, Collignon F. Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS(®) in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. 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; 21:2565-72. [PMID: 22565799 DOI: 10.1007/s00586-012-2330-z] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/26/2011] [Revised: 03/26/2012] [Accepted: 04/17/2012] [Indexed: 12/18/2022]
Abstract
PURPOSE New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). APERIUS(®) is a minimally invasive IPD that can be implanted percutaneously. This multicentre prospective study was designed to make a preliminary evaluation of safety and effectiveness of this IPD up to 12 months post-implantation. METHODS After percutaneous implantation in 156 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months. RESULTS Early symptom and physical function improvements were maintained for up to 12 months, when 60 and 58 % of patients maintained an improvement higher than the Minimum Clinically Important Difference for Zurich Claudication Questionnaire (ZCQ) symptom severity and physical function, respectively. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 9 % of patients due to complications or lack of effectiveness. CONCLUSIONS Overall, in a period of up to 12 months follow-up, the safety and effectiveness of the APERIUS(®) offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are underway to provide insight on outcomes and effectiveness compared to other decompression methods, and to develop guidance on optimal patient selection.
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Affiliation(s)
- Jan Van Meirhaeghe
- Dienst Orthopedie en Traumatologie, AZ Sint-Jan Brugge-Oostende AV, Ruddershove 10, 8000 Brugge, Belgium.
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Alfieri A, Gazzeri R, Prell J, Scheller C, Rachinger J, Strauss C, Schwarz A. Role of lumbar interspinous distraction on the neural elements. Neurosurg Rev 2012; 35:477-84; discussion 484. [PMID: 22549123 DOI: 10.1007/s10143-012-0394-1] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2010] [Revised: 09/03/2011] [Accepted: 03/01/2012] [Indexed: 12/19/2022]
Abstract
The interspinous distraction devices are used to treat variable pathologies ranging from facet syndrome, diskogenic low back pain, degenerative spinal stenosis, diskopathy, spondylolisthesis, and instability. The insertion of a posterior element with an interspinous device (ISD) is commonly judged responsive to a relative kyphosis of a lumbar segment with a moderate but persistent increase of the spinal canal and of the foraminal width and area, and without influence on low-grade spondylolisthesis. The consequence is the need of shared specific biomechanical concepts to give for each degenerative problem the right indication through a critical analysis of all available experimental and clinical biomechanical data. We reviewed systematically the available clinical and experimental data about kyphosis, enlargement of the spinal canal, distraction of the interspinous distance, increase of the neural foramina, ligamentous structures, load of the posterior annulus, intradiskal pressure, strength of the spinous processes, degeneration of the adjacent segment, complications, and cost-effectiveness of the ISD. The existing literature does not provide actual scientific evidence over the superiority of the ISD strategy, but most of the experimental and clinical data show a challenging potential. These considerations are applicable with different types of ISD with only few differences between the different categories. Despite--or because of--the low invasiveness of the surgical implantation of the ISD, this technique promises to play a major role in the future degenerative lumbar microsurgery. The main indications for ISD remain lumbar spinal stenoses and painful facet arthroses. A clear documented contraindication is the presence of an anterolisthesis. Nevertheless, the existing literature does not provide evidence of superiority of outcome and cost-effectiveness of the ISD strategy over laminectomy or other surgical procedures. At this time, the devices should be used in clinical randomized independent trials in order to obtain more information concerning the most advantageous optimal indication or, in selected cases, to treat tailored indications.
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Affiliation(s)
- Alex Alfieri
- Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Germany.
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Surace MF, Fagetti A, Fozzato S, Cherubino P. Lumbar spinal stenosis treatment with Aperius perclid interspinous system. 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 1:S69-S74. [PMID: 22430539 PMCID: PMC3325379 DOI: 10.1007/s00586-012-2222-2] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/14/2012] [Accepted: 02/19/2012] [Indexed: 10/28/2022]
Abstract
PURPOSE The purpose of this study is to report clinical outcome and imaging changes of percutaneous Aperius stand-alone implant in patients with degenerative lumbar spinal stenosis and neurogenic intermittent claudication, which did not respond to conservative treatment. METHOD Between January 2008 and July 2010, 37 patients (20 males and 17 females) with mean age of 64.3 years underwent surgery for the onset of claudicatio spinalis with Aperius PercLID interspinous device (Medtronic). In all patients, the diagnosis was: foraminal stenosis, in one case (2.7 %) it was associated to a degenerative anterior listhesis (I grade), in three cases (8.1 %) it was associated to an intraforaminal disc herniation. The mean follow-up was of 18 months (range 2-35 months). The patients were evaluated through the Oswestry disability index, Zurich Claudication Questionnaire (ZCQ), VAS scales. In all cases were obtained preoperative and in postoperative radiographs and magnetic resonance imaging. RESULTS The VAS score decreased significantly after surgery: the patients presented a mean VAS of seven preoperatively and two postoperatively (p < 0.001). The ZCQ score significantly decreased postoperatively, with an average reduction of 21.89 % (p < 0.001). The ODI score as well showed a significant reduction postoperatively of an average 26.09 % (p < 0.001). CONCLUSION Despite of the brief follow up, the preliminary results are encouraging, showing a significantly decrease of the disability parameters, a marked improvement of the function with the vanishing of the claudicatio spinalis and the following increase of the free interval during the walk. Aperius PercLID system seems to offer an alternative to the traditional decompression surgery.
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Affiliation(s)
- M F Surace
- Department of Orthopaedic and Trauma Sciences M Boni, Universitas Studiorum Insubriae, Viale Borri 57, 21100 Varese, Italy.
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Bonaldi G, Bertolini G, Marrocu A, Cianfoni A. Posterior vertebral arch cement augmentation (spinoplasty) to prevent fracture of spinous processes after interspinous spacer implant. AJNR Am J Neuroradiol 2011; 33:522-8. [PMID: 22194371 DOI: 10.3174/ajnr.a2792] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/02/2023]
Abstract
BACKGROUND AND PURPOSE Interspinous spacers are implanted to treat symptomatic lumbar stenosis. Posterior vertebral element fractures can occur during or after interspinous spacer implants, especially in patients with osteopenia. The purpose of our study was to assess the biomechanical rationale, safety, feasibility, and effectiveness of posterior vertebral arch cement augmentation (spinoplasty) in preventing delayed spinous process fractures after interspinous spacer implants in patients with risk factors for fragility fractures. MATERIALS AND METHODS We performed a nonrandomized historically controlled clinical trial. From June 2007 to March 2010, we implanted interspinous spacers in 35 eligible patients with fragility-fracture risk factors. In 19/35 patients treated after April 2009, after we assessed the theoretic biomechanical effects of cement augmentation of the spinous process and laminae by FEM, a percutaneous spinoplasty was also performed. Clinical and radiologic follow-up ranged between 12 and 36 months after the intervention. RESULTS No intraprocedural spinous process fractures were observed in either group, and no patients in the 24-hour postoperative period had complications that were procedure-related. Symptomatic delayed spinous process fractures were diagnosed in 4/16 patients who did not undergo spinoplasty (25.0%), while no fractures were diagnosed in the 19 treated patients (P = .035). CONCLUSIONS Spinoplasty is feasible and safe. It has a biomechanical rationale, as demonstrated by an FEM. In our preliminary experience, it seems effective in preventing delayed fractures of the posterior arch post-interspinous spacer placement in patients at risk for fragility fractures. These patients have a significant risk of developing a symptomatic delayed spinous process fracture if not treated with spinoplasty.
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Affiliation(s)
- G Bonaldi
- Department of Neuroradiology, Ospedali Riuniti, Bergamo, Italy.
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Moojen WA, Arts MP, Bartels RHMA, Jacobs WCH, Peul WC. Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-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 2011; 20:1596-606. [PMID: 21667130 PMCID: PMC3175877 DOI: 10.1007/s00586-011-1873-8] [Citation(s) in RCA: 45] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/24/2011] [Accepted: 05/31/2011] [Indexed: 02/02/2023]
Abstract
INTRODUCTION Despite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects. METHODS Data from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded. RESULTS Eleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5-27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%. CONCLUSION As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced.
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Affiliation(s)
- Wouter A. Moojen
- Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, 2300 RC Leiden, The Netherlands
- Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands
| | - Mark P. Arts
- Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands
| | | | - Wilco C. H. Jacobs
- Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, 2300 RC Leiden, The Netherlands
| | - Wilco C. Peul
- Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, 2300 RC Leiden, The Netherlands
- Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands
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Shabat S, Miller LE, Block JE, Gepstein R. Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer. Clin Interv Aging 2011; 6:227-33. [PMID: 21966217 PMCID: PMC3180519 DOI: 10.2147/cia.s23656] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
Purpose To assess the safety and effectiveness of a novel, minimally invasive interspinous spacer in patients with moderate lumbar spinal stenosis (LSS). Methods A total of 53 patients (mean age, 70 ± 11 years; 45% female) with intermittent neurogenic claudication secondary to moderate LSS, confirmed on imaging studies, were treated with the Superion® Interspinous Spacer (VertiFlex, Inc, San Clemente, CA) and returned for follow-up visits at 6 weeks, 1 year, and 2 years. Study endpoints included axial and extremity pain severity with an 11-point numeric scale, Zurich Claudication Questionnaire (ZCQ), back function with the Oswestry Disability Index (ODI), health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-12, and adverse events. Results Axial and extremity pain each decreased 54% (both P < 0.001) over the 2-year follow-up period. ZCQ symptom severity scores improved 43% (P < 0.001) and ZCQ physical function improved 44% (P < 0.001) from pre-treatment to 2 years post-treatment. A statistically significant 50% improvement (P < 0.001) also was noted in back function. PCS and MCS each improved 40% (both P < 0.001) from pre-treatment to 2 years. Clinical success rates at 2 years were 83%–89% for ZCQ subscores, 75% for ODI, 78% for PCS, and 80% for MCS. No device infection, implant breakage, migration, or pull-out was observed, although two (3.8%) patients underwent explant with subsequent laminectomy. Conclusion Moderate LSS can be effectively treated with a minimally invasive interspinous spacer. This device is appropriate for select patients who have failed nonoperative treatment measures for LSS and meet strict anatomical criteria.
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Affiliation(s)
- Shay Shabat
- Spinal Care Unit, Sapir Medical Center, Kfar Saba, Israel
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