In:
International Journal of Clinical Trials, Medip Academy, Vol. 3, No. 3 ( 2016-08-06), p. 120-
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.
Type of Medium:
Online Resource
ISSN:
2349-3259
,
2349-3240
DOI:
10.18203/2349-3259.ijct20162794
Language:
Unknown
Publisher:
Medip Academy
Publication Date:
2016
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