RecruitingNCT05329129
OssDsign® Spine Registry Study ("Propel")
PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
Sponsor
OssDsign
Enrollment
450 participants
Start Date
Mar 23, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 21 Years
Inclusion Criteria4
- 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.
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Interventions
DEVICEOssDsign® Catalyst
An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05329129
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