Original Research ArticleInternational Journal of Clinical Trials
Publication: A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation
Int J Clin Trials. 2016;3(3):120-131.DOI10.18203/2349-3259.ijct20162794
Abstract
Background Same-level reherniation and progressive degeneration with disc height loss are main causes of poor outcome after discectomy and may necessitate reoperation. A novel prosthesis for anular closure was developed to address these causes.
Methods The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited lumbar discectomy augmented with this device (intervention group) with limited lumbar discectomy alone (control group) is presented.
Results Patients with single-level (L1-S1) posterior or posterolateral disc herniation and radiologic confirmation of neural compression for whom at least six weeks of conservative treatment has failed are eligible. Patients must have posterior disc height ≥5 mm at index level and baseline Oswestry and VAS leg pain scores of ≥40/100. Intraoperatively, subjects meeting anular defect size criteria post-discectomy (4-6 mm tall and 6-10 mm wide) will be randomized to study groups in a 1:1 ratio using centralized, web-based software. A Bayesian statistical approach will be used to enroll 400 to 800 subjects who will be followed for at least 24 months. Two co-primary endpoints will be assessed at 24 months: 1) a composite of leg pain, clinical function, disc height maintenance, and absence of reherniation, reoperation, and device failure; and 2) absence of reherniation based upon independent radiologic analysis.
Conclusions This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.
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Affiliations
- Department of Neurosurgery, St. Bonifatius Hospital GmbH Department of Neurosurgery Wilhelmstraße 13 49808 Lingen
- Department of Neurosurgery, AZ Klina, Department of Neurosurgery, Brasschaat, Belgium
- Sint Lucas-Andreas Ziekenhuis and Academic Medical Center, Department of Neurosurgery, Amsterdam, The Netherlands
- LKH-Univ. Klinikum Graz Department of Neurosurgery Graz, Austria
- University Hospital, Department of Neurosurgery, Bochum, Germany
- DONAUISAR Klinikum Deggendorf, Department of Neurosurgery and Interventional Neuroradiology, Deggendorf, Germany
- University Hospital, Department of Neurosurgery, Kiel, Germany
- Klinikum Augsburg, Department of Neurosurgery, Augsburg, Germany
- University Hospital, Department of Neurosurgery, Düsseldorf, Germany
- Innsbruck Medical University, Department of Neurosurgery, Innsbruck, Austria
- Charité Universitätsmedizin, Department of Neurosurgery, Berlin, Germany
- Asklepios Westklinikum Hamburg, Department of Neurosurgery, Hamburg, Germany
- Kantonsspital Aarau, Department of Neurosurgery, Aarau, Switzerland
- Centre Hospitalier Régional Universitaire de Lille, Department of Neurosurgery, Lille, France
- AZ Nikolaas, Sint-Niklaas, Belgium
- Orthopädische Klinik und Poliklinik der Universität Rostock, Rostock, Germany
- Neurochirurgisch Centrum Zwolle, Zwolle, The Netherlands
- Universitätsmedizin Mannheim, Department of Neurosurgery, Mannheim, Germany
- MCH Westeinde, Department of Neurosurgery, Den Hague, The Netherlands
- MCH Antoniushove, Department of Neurosurgery, Leidschendam, The Netherlands
- OLV Ziekenhuis, Department of Neurosurgery, Aalst, Belgium