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

Abstract

<p class="abstract"><strong>Background:</strong> 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.</p><p class="abstract"><strong>Methods:</strong> 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.</p><p class="abstract"><strong>Results:</strong> 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. </p><strong>Conclusions:</strong> This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.

Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge

“…The primary objective of the study was to determine safety and effectiveness of adjunctive ACD placement through 2-year follow-up in patients at high risk of herniation recurrence. 6 We report here a post hoc analysis of perioperative complication data from this study. The study was approved by the local ethics committee at each site and all patients provided written informed consent.…”

Predictors of Treatment Success Following Limited Discectomy With Annular Closure for Lumbar Disc Herniation

“…The bone-anchored ACD used in this study has been the subject of many other clinical studies and reports, including a RCT of 550 patients with large annular defects. 22,44 That study observed a significant reduction in symptomatic reherniation, from 25% in the control group (discectomy alone) to 12% in the ACD group after 2 years. Furthermore, the reoperation rate for reherniations was reduced by more than 60%.…”

Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial

“…This study was prospectively registered at ClinicalTrials.gov (NCT01283438). Details of the study rationale, design, and methods have been described previously [13].…”