Spinal Stenosis Clinical Trial
— VPRCTOfficial title:
Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial
To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)
Status | Not yet recruiting |
Enrollment | 164 |
Est. completion date | December 2028 |
Est. primary completion date | September 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Single-level or two-level lumbar surgery needed - Indication for decompression surgery in patients with spinal canal stenosis and additional stable degenerative listhesis (without facet joint effusion = 2mm) - Indication for fusion surgery in patients with spinal canal stenosis and additional unstable degenerative listhesis (facet joint effusion = 2mm), in patients with foraminal stenosis and additional degenerative listhesis, and in patients with segment degeneration of the disc - Understanding in German language Exclusion criteria: - Indication for decompression and/or fusion surgery in patients with solely disc herniation, fractures, lytic listhesis, tumor - Patients undergoing revision surgery for infection - Patients undergoing revision surgery on the same level if bony structures have been removed (e.g. prior laminectomy or midline decompression) - Patients undergoing revision surgery in case of prior fusion surgery - Inability to understand the study for linguistic or cognitive reasons - Anticipated clinical follow-up of less than 6 weeks after inclusion - Participation in other clinical trials |
Country | Name | City | State |
---|---|---|---|
Switzerland | Balgrist University Hospital | Zurich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital |
Switzerland,
Calek AK, Altorfer F, Fasser MR, Widmer J, Farshad M. Interspinous and spinolaminar synthetic vertebropexy of the lumbar spine. Eur Spine J. 2023 Sep;32(9):3183-3191. doi: 10.1007/s00586-023-07798-y. Epub 2023 Jun 7. — View Citation
Calek AK, Widmer J, Fasser MR, Farshad M. Lumbar vertebropexy after unilateral total facetectomy. Spine J. 2023 Nov;23(11):1730-1737. doi: 10.1016/j.spinee.2023.07.005. Epub 2023 Jul 13. — View Citation
Farshad M, Tsagkaris C, Widmer J, Fasser MR, Cornaz F, Calek AK. Vertebropexy as a semi-rigid ligamentous alternative to lumbar spinal fusion. Eur Spine J. 2023 May;32(5):1695-1703. doi: 10.1007/s00586-023-07647-y. Epub 2023 Mar 17. — View Citation
Widmer J, Cornaz F, Scheibler G, Spirig JM, Snedeker JG, Farshad M. Biomechanical contribution of spinal structures to stability of the lumbar spine-novel biomechanical insights. Spine J. 2020 Oct;20(10):1705-1716. doi: 10.1016/j.spinee.2020.05.541. Epub 2020 May 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ODI (Oswestry Disability Index) | To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery | 2 years postoperative | |
Secondary | VAS (Visual Analogue Scale) | To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery. VAS scale 0-10, 10 meaning the highest pain score and 0 no pain at all. | 2 years postoperative | |
Secondary | SSM symptoms/function (Spinal Stenosis Measure) | To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery | 2 years postoperative | |
Secondary | SSM satisfaction (Spinal Stenosis Measure) | To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery | 2 years postoperative | |
Secondary | EQ-5D (European Quality of Life Five Dimension) | To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery | 2 years postoperative | |
Secondary | Revision surgery | surgery on same and/or on adjacent levels | 2 years postoperative | |
Secondary | Complications | - intraoperative: lesion of nerve root, dural tear, lesion of vessels
- postoperative: surgical site infection, wound healing disorder, hematoma, paresis, material loosening (with fusion), material failure (with fusion), pseudarthrosis (with fusion), fracture, allograft tendon rupture (with vertebropexy) - non-surgical: anesthesiological, cardiovascular, pulmonal, thromboembolic, death |
2 years postoperative | |
Secondary | Duration of surgery | Duration of intervention in minutes | Perioperative | |
Secondary | Length of hospital stay | Duration of hospital stay in days | Perioperative | |
Secondary | Intraoperative blood loss | Blood loss intraoperative in ml | Perioperative | |
Secondary | Use of analgesia | Intake of analgetics | 2 years postoperative | |
Secondary | Use of physical therapy | Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit) | 2 years postoperative |
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