Registry for patients using OssDsign® bone grafts in spine fusion
Official title: PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
Run by OssDsign · NCT05329129 · Data updated 2026-11-12
This study is tracking how well OssDsign® bone grafts work for people having spine fusion surgery to see if they help with recovery over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | OssDsign Industry-sponsored |
| Locations | 16 sites (Fresno, California and 15 other locations) |
| Status | Recruiting |
| Started | March 23, 2022 |
| Main results expected | March 23, 2030 |
| Study ends | April 1, 2030 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT05329129 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 and older who are diagnosed as candidates for spinal fusion surgery and for whom an OssDsign® bone graft is deemed appropriate by their surgeon.
✕Probably not a fit
Patients who do not meet the inclusion criteria or are not candidates for spinal fusion surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center, prospective, observational registry aims to collect data on the clinical outcomes and real-world application of OssDsign® bone graft substitutes in patients undergoing spine fusion. The study will involve up to 300 subjects across 10 US sites, with participants followed for 24 months after their surgery. The registry is part of OssDsign®'s post-market surveillance to evaluate the effectiveness and safety of their bone grafts in treating conditions like degenerative disc disease and spinal stenosis.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of OssDsign® bone grafts, potentially improving patient outcomes in spine fusion surgeries.
How similar studies have gone: Other studies on bone graft substitutes have shown promising results, indicating that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Community Health Partners Neuroscience
Fresno, California, United States Recruiting -
Memorial Orthopaedic Surgical Group
Long Beach, California, United States Recruiting -
Orthopedic Associates of Hartford
Hartford, Connecticut, United States Recruiting -
Central Connecticut Neurosurgery and Spine
New Britian, Connecticut, United States Recruiting -
Minimally Invasive Spine Center of South Florida
Miami, Florida, United States Recruiting -
Michigan Orthopaedic Surgeons
Southfield, Michigan, United States Recruiting
Show 10 more locations
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University Orthopedics Center
State College, Pennsylvania, United States Recruiting -
Texas Spine Consultants
Addison, Texas, United States Recruiting -
San Diego Neurosurgery
San Diego, California, United States Terminated -
Yale Center for Clinical Investigation, Yale School of Medicine
New Haven, Connecticut, United States Active not recruiting -
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States Active not recruiting -
Northeast Georgia Medical Center
Gainesville, Georgia, United States Active not recruiting -
Carle Foundation Hospital, NeuroScience Institute
Urbana, Illinois, United States Completed -
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States Completed -
OrthoBethesda Research Foundation
Bethesda, Maryland, United States Completed -
Twin Cities Orthopedics
Edina, Minnesota, United States Active not recruiting
Study contacts
- Study coordinator: jeff Feldhaus
- Email: jfeldhaus@msquaredassociates.com
- Phone: 13476694903
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.