Spineology U.S. Clinical Trial for Interbody Fusion
By Admin | October 10, 2018
The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized 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 painful 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 ten participating study sites, and study enrollment is complete. Dr. Chi and his co-authors reported on 102 treated subjects, of whom 80 have completed 12-month postoperative follow-up and 27 of have completed 24-month follow-up.
To read more, please read, Spineology U.S. Clinical Trial for Interbody Fusion by oaoa.com.