OssDsign® Spine Registry Study ("Propel")
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorOssDsign
About this trial
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
Qualifiers
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.
Disqualifiers
Patients not meeting all of the inclusion criteria
Trial design
Treatments tested in this trial
- OssDsign® Catalyst
Treatment groups
No treatment groups listed
Locations
15California
Community Health Partners Neuroscience93720, Fresno United States
Memorial Orthopaedic Surgical Group90806, Long Beach United States
San Diego Neurosurgery92024, San Diego United States
Connecticut
Orthopedic Associates of Hartford06102, Hartford United States
Sponsors and collaborators
OssDsign
Lead sponsor
Source ClinicalTrials.gov