Status:
RECRUITING
OssDsign® Spine Registry Study ("Propel")
Lead Sponsor:
OssDsign
Conditions:
Degenerative Disc Disease
Spinal Stenosis
Eligibility:
All Genders
21+ years
Brief 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...
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 b...
Eligibility Criteria
Inclusion
- The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.
- The patient is ≥21 years old.
- The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
- The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years.
- Exclusion Criteria:
- Patients not meeting all of the inclusion criteria
Exclusion
Key Trial Info
Start Date :
March 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05329129
Start Date
March 23 2022
End Date
April 1 2027
Last Update
December 2 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Community Health Partners Neuroscience
Fresno, California, United States, 93720
2
San Diego Neurosurgery
San Diego, California, United States, 92024
3
Orthopedic Associates of Hartford
Hartford, Connecticut, United States, 06102
4
Central Connecticut Neurosurgery and Spine
New Britian, Connecticut, United States, 06051