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Recruiting
NCT05329129
OssDsign® Spine Registry Study ("Propel")
Conditions: Degenerative Disc Disease, Spinal Stenosis
Sex: All
Ages: 21 Years – N/A
Enrollment: 450
Sponsor: OssDsign
Location: Community Health Partners Neuroscience Fresno California
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 Criteria
* 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
Source: ClinicalTrials.gov (NCT05329129). StuddyBuddy aggregates publicly available trial information.