NCT05329129

OssDsign® Spine Registry Study ("Propel")

PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: OssDsign · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

Summary

The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.

Detailed description

This multi-center study (up to 15 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 450 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.

Conditions

• Degenerative Disc Disease
• Spinal Stenosis

Interventions

Type	Name	Description
DEVICE	OssDsign® Catalyst	An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler

Timeline

• Start date: 2022-03-23
• Primary completion: 2027-03-23
• Completion: 2027-04-01
• First posted: 2022-04-14
• Last updated: 2025-12-02

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study