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
Sponsors and collaborators
Source ClinicalTrials.gov