The study was a prospective, randomized, multi-center FDA IDE trial comparing direct decompression and coflex interlaminar stabilization with laminectomy and posterior spinal fusion. Two hundred nineteen patients (146 coflex and 73 fusion controls) were randomized and treated from 21 sites in the United States to receive direct decompression and coflex interlaminar stabilization or laminectomy and posterolateral spinal fusion with spinal instrumentation in a 2:1 ratio.
The study’s patient follow-up at two years was 96.6 percent and 98.6 percent for coflex and fusion control groups, respectively. Coflex patients experienced shorter operative times, estimated blood loss and length of stay compared with fusion controls. At two years, fusion controls exhibited significantly increased translation and angulation at the superior adjacent level, while coflex maintained normal operative and adjacent level motion.
From the same study, investigators classified the severity of each adverse event, and the relationship of the event to surgery and device. An independent CEC, comprised of three independent, blinded spinal surgeons without affiliation to the study sponsor, reviewed all adverse event reports submitted by the investigators and re-adjudicated and re-classified all adverse event reports. All CEC adjudications were binding on the sponsor.
The results of this analysis demonstrated investigator bias in the reporting of adverse events. Thirty-seven percent of adverse events were adjudicated by the CEC, the vast majority of which were upgrades in the level of severity, or a designation of greater relatedness to surgery or device. This demonstrates that an independent CEC can identify and mitigate potential inherent investigator bias and facilitate an accurate assessment of investigational device safety, and should be considered requisite in future clinical trials, according to the study.
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