NCT05329129 OssDsign® Spine Registry Study ("Propel")
| NCT ID | NCT05329129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OssDsign |
| Condition | Degenerative Disc Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2022-03-23 |
| Primary Completion | 2030-03-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2022-03-23 with a primary completion date of 2030-03-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Melanie Marshall
STUDY DIRECTOR
OssDsign
Frequently Asked Questions
Who can join the NCT05329129 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05329129 currently recruiting?
Yes, NCT05329129 is actively recruiting participants. Contact the research team at jfeldhaus@msquaredassociates.com for enrollment information.
Where is the NCT05329129 trial being conducted?
This trial is being conducted at Fresno, United States, Long Beach, United States, San Diego, United States, Hartford, United States and 11 additional locations.
Who is sponsoring the NCT05329129 clinical trial?
NCT05329129 is sponsored by OssDsign. The principal investigator is Melanie Marshall at OssDsign. The trial plans to enroll 450 participants.