Prospective Observational Study on Spine Fusion Using OssDsignae Bone Grafts to Track Real-World Patient Outcomes

What this Trial Is About

This research aims to collect information on the real-world use and clinical outcomes of OssDsignAE bone graft substitutes in patients needing spine fusion surgery. It is a multi-center, prospective, observational registry involving up to 25 US study sites. The study focuses on post-market surveillance to monitor the performance of OssDsignAE products in routine clinical practice for conditions like degenerative disc disease and spinal stenosis. Participants will receive spine fusion surgery using OssDsignAE bone grafts, specifically the OssDsignAE Catalyst device, which is a porous, synthetic calcium phosphate bone void filler. The study plans to recruit about 750 participants initially, who will be followed for up to 24 months B1 90 days after their surgery. This period allows evaluation of the bone fusion process and related outcomes over time. During the study, participants will undergo clinical and radiographic follow-up assessments at various intervals, including 6, 12, and 24 months post-surgery. Researchers will measure the rate of bone fusion at 12 months and monitor quality of life through questionnaires assessing disability and pain, as well as neurological function. Safety will also be reviewed continuously for any device-related adverse events throughout the two-year follow-up period.

OssDsign® Spine Registry Study ("Propel")