Spineology has announced that 24-month outcomes data from SCOUT clinical trial were presented by John Chi (Brigham and Women’s Hospital, Boston, USA), at the recent Society for Minimally Invasive Spine Surgery (SMISS) annual meeting (SMISS Annual Forum; 31 October–2 November, Las Vegas, USA).
The SCOUT study (Spineology Clinical Outcomes Trial), conducted under a US Food and Drug Administration (FDA)-approved IDE protocol, is a prospective, multi-centre, non-randomised performance goal investigation designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).
The fusion implant used in the SCOUT Study is Spineology’s porous graft containment mesh that deploys within the disc space as it is filled, permitting the packed bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.
The SCOUT trial includes 102 patients who were experiencing lumbar degenerative disc disease of at least six months’ duration. Patients are skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion. Patients have been enrolled at 10 participating study sites, and study enrollment is complete. Chi and his co-authors reported on 102 treated subjects, of whom 82 have completed 24-month follow-up to date. Follow-up remains ongoing for the remaining 17 subjects.
Improvements were seen at six, 12 and 24 months in scores for low back pain and functional limitations, as recorded by visual analogue scale (VAS) and Oswestry Disability Index (ODI) respectively. Current data available through 24 months yields a fusion rate of 98%, as read on CT by two independent radiologists. Approximately 90% of subjects reported “Excellent” or “Good” patient satisfaction at six, 12 and 24 months. An excellent safety record was reported as there were no unanticipated adverse events and no interbody device-related serious adverse events.
“We have found this innovative minimally invasive graft containment device to be a safe and effective option for lumbar interbody fusion procedures,” said Chi. “Patient-reported outcomes are very favourable, including improved function, reduced pain and high satisfaction rates. Combined with excellent safety and radiographic fusion, the SCOUT study is demonstrating very favourable results.”
Spineology’s OptiMesh deployable implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data in support of a regulatory submission to FDA for expanded indications, allowing the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating DDD.
Spineology chief executive John Booth, said: “We are very pleased to know that SCOUT patients have reported highly positive outcomes early on, and these improvements have been maintained or increased over time. We look forward to completing patient follow-up and gaining the clearance that will allow us to market this unique fusion device.”