Paradigm Spine has announced the release of positive key findings based on its landmark coflex IDE study.
At ISASS (Barcelona, Spain, 20–23 March 2012), Josh Auerbach, chief of Spine Surgery, Bronx-Lebanon Hospital Center and assistant professor of Surgery, Albert Einstein College of Medicine, USA, presented the results of a study titled: “Coflexinterlaminar stabilisation compared to posterior spinal fusion”. The study was a prospective, randomised, multicentre FDA IDE trial comparing direct decompression and coflex interlaminar stabilisation with laminectomy and posterior spinal fusion. Two hundred and nineteen patients (146 coflex and 73 fusion controls) were randomised and treated from 21 sites in the USA to receive direct decompression and coflex interlaminar stabilisation 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% and 98.6% for coflex and fusion control groups, respectively. Coflex patients experienced shorter operative times, estimated blood loss and length of stay compared to 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. In conclusion, the study results demonstrate safety, efficacy and non-inferiority of decompression followed by coflex interlaminar stabilisation compared to fusion. Coflex led to significantly improved perioperative outcomes, multiple clinical outcomes measures and maintenance of motion at operative and adjacent levels compared with fusion at two years.