Prospective, Multi-Center, Randomized, Controlled Study of Anular Repair in Lumbar Discectomy: Two-Year Follow-Up.
Spine (Phila Pa 1976). 2013 Feb 7;
Authors: Bailey A, Araghi A, Blumenthal S, Huffmon GV, and the Anular Repair Clinical Study Group
ABSTRACT: Study Design. Prospective, multi-center, single-blind, randomized, controlled clinical study.Objective. To investigate outcomes associated with repairing the anulus fibrosus following lumbar discectomy for the surgical management of herniated nucleus pulposus.Summary of Background Data. In patients undergoing discectomy, the incidence of reherniation ranges from 10 to 15%. Repair of the anulus fibrosus defect following lumbar discectomy may decrease the incidence of recurrent herniation for these patients.Methods. A total of 750 patients were treated for herniated lumbar discs and randomly assigned in a 2:1 ratio to discectomy with the Xclose™ Tissue Repair System for anular repair (n = 500) or discectomy without anular repair (n = 250). Patient self-reported measures included Visual Analog Scales for Leg and Back Pain, Oswestry Disability Index, and Short Form-12 Health Survey. Adverse events and subsequent reherniation surgeries were documented. Pre-operative outcome measures were compared to follow-up visits at two-weeks, six-months, one-year and two-years.Results. Patient symptoms were improved after surgery in an equivalent manner in both study groups. In the overall study analysis, the rate of reherniation surgery was lower for Xclose patients at all follow-up time points, however these differences were not statistically-significant. In patients with predominant leg pain, there was a significant reduction in reherniation risk at three and six-months post-operation for patients receiving Xclose. A positive reduction was maintained through two-years, with a clinically-relevant risk reduction of 45%, although not statistically-significant. Safety was demonstrated with similar improvements in patient outcomes and no difference in reported adverse events.Conclusion. Without a safe and effective method for closing the anulus fibrosus after discectomy, current practice has been to leave the anulus in a compromised state. This multi-center randomized study demonstrated that, while not statistically-significant, anular repair reduced the need for subsequent reherniation surgery while retaining the benefits of discectomy with no increased risk for patients.
PMID: 23392414 [PubMed – as supplied by publisher]