Artikel
A multicenter, prospective, randomized study to demonstrate the superiority of a bone-anchored prosthesis for annular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation
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Autoren
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Peter Douglas Klassen
- St. Bonifatius Hospital, Department of Neurosurgery, Lingen, Germany
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Robert Hes
- ZNA Middelheim, Department of Neurosurgery, Antwerp, Belgium
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Gerrit J. Bouma
- Sint Lucas-Andreas Ziekenhuis and Academic Medical Center, Department of Neurosurgery, Amsterdam, The Netherlands
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Sandro Eustacchio
- Medical University Graz, Department of Neurosurgery, Graz, Austria
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Martin Barth
- University Hospital, Department of Neurosurgery, Mannheim, Germany
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Stefan Rath
- Klinikum Deggendorf, Department of Neurosurgery and Interventional Neuroradiology, Deggendorf, Germany
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H. Maximilian Mehdorn
- University Hospital, Department of Neurosurgery, Kiel, Germany
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Volkmar Heidecke
- Klinikum Augsburg, Department of Neurosurgery, Augsburg, Germany
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Richard Bostelmann
- University Hospital, Department of Neurosurgery, Dusseldorf, Germany
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Claudius Thomé
- Innsbruck Medical University, Department of Neurosurgery, Innsbruck, Austria
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Peter Vajkoczy
- Charité Universitätsmedizin, Department of Neurosurgery, Berlin, Germany
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Hans-Peter Köhler
- Asklepios Westklinikum Hamburg, Department of Neurosurgery, Hamburg, Germany
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Frederic Martens
- OLV Ziekenhuis, Department of Neurosurgery, Aalst, Belgium
| Veröffentlicht: | 21. Mai 2013 |
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Gliederung
Text
Objective: 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. The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited posterior lumbar discectomy augmented with this device (intervention group) with limited posterior lumbar discectomy alone (control group) is presented.
Method: 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. Trial subgroups include subjects blinded to group allocation and those who contribute additional cost data to determine cost-effectiveness of treatment.
Results: Demonstrate superiority of limited discectomy augmented with the device compared with limited discectomy alone in preventing recurrent pain, dysfunction, and herniation.
Conclusions: To our knowledge, this is the first randomized, controlled trial evaluating a bone-anchored prosthesis for anular closure and the largest multi-country, prospective discectomy study.
