One Year Outcomes of a New Conformal Mesh Interbody Fusion D
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In subjects undergoing single-level fusion for degenerative disc disease, a prospective multicenter investigative device-exempt trial is underway to test a novel conformal mesh interbody fusion device. Enrollment was given to patients meeting inclusion and exclusion requirements. The goal of this study was to determine the short and long-term safety and efficacy of a novel conformable mesh interbody fusion system for subjects undergoing single-level fusion unresponsive to conservative treatment for degenerative disc disease.

Transforaminal lumbar interbody fusion remains a critical procedure for patients with degenerative lumbar disc disease. Increasingly minimally invasive techniques have been proposed to minimize muscle dissection and tissue damage with the goal of minimizing pain and length of stay.

Analysis included 102 subjects out of which 99 subjects remained available for follow-up at 12-months. Physical evaluations/imaging were performed serially through 12-months. Validated assessment tools included 100 mm visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI) for function, and computerized tomography scan for fusion. Independent committees were used to identify adverse events and for assessment of radiographic fusion.

--Reductions in low back pain (LBP)/leg pain and improvements in functional status occur early and are maintained through 12-month follow-up.
--Mean VAS-LBP change from baseline to 6-weeks post-op (–46 mm) continued to improve through 12 months (–51 mm).
--Similar trends were observed for leg pain. Mean ODI change from baseline to 6 weeks post-op (–17) was almost doubled by 12 months (–32). Fusion rates at 12-months are high (98%). --No device-related serious adverse events have occurred.

Over 12 months, outcomes showed excellent patient compliance and positive pain, work, fusion, and system safety performance. By 6 weeks post-op, clinical results have been observed and tend to be durable up to 1 year later. An alternative means of interbody fusion that decreases connective tissue disruption may be provided by a novel mesh interbody system.