One year outcomes from a prospective multicenter investigation device trial of a novel conformal mesh interbody fusion device
Spine Dec 26, 2020
Driver J, Huang KT, Krag M, et al. - This study was sought to develop the short and long-term safety and efficacy of a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease unresponsive to conservative care. Researchers included a total of 102 individuals across 10 sites. At 12-months, ninety- nine individuals remained available for follow-up. They conducted physical evaluations/imaging serially through 12-months. They applied independent committees to distinguish adverse events and for evaluation of radiographic fusion. This study’s findings demonstrated that the 12-month outcomes revealed excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. They found clinical improvements by 6-weeks post-op and appear durable up to 1 year later. It was reported that a novel mesh interbody device may provide an alternative means of interbody fusion that decreases connective tissue disruption.
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