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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 Aug;3(3):120-131
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AUTHORS:
PD Klassen, R Hes, GJ Bouma, S Eustacchio, M Barth, A Kursumovic, S Jadik, V Heidecke, R Bostelmann, C Thomé, P Vajkoczy, HP Köhler, J Fandino, R Assaker, E Van de Kelft, S Fröhlich, W van den Brink, J Perrin, J Wolfs, M Arts, F Martens
 

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.

CONCLUSION:

This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.

KEYWORDS

Disc herniation, Reherniation, Anular closure, Discectomy