OBJECTIVE: Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid(R) annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor. METHODS: We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid(R) after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up. RESULTS: At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed. CONCLUSION: The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increa- sed confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing dege- neration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid(R) is currently underway, and will provide a higher level of evidence.
Biomechanics ; Diskectomy ; Humans ; Hypogonadism ; Mitochondrial Diseases ; Ophthalmoplegia ; Polymers ; Prospective Studies ; Recurrence ; Titanium