Registry for patients using OssDsign® bone grafts in spine fusion
PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
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 |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | OssDsign Industry-sponsored |
| Locations | 15 sites (Fresno, California and 14 other locations) |
| Trial ID | NCT05329129 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies on bone graft substitutes have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
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 this trial is running
Fresno, California and 14 other locations
- Community Health Partners Neuroscience — Fresno, California, United States (Recruiting)
- Memorial Orthopaedic Surgical Group — Long Beach, California, United States (Recruiting)
- San Diego Neurosurgery — San Diego, California, United States (Terminated)
- Orthopedic Associates of Hartford — Hartford, Connecticut, United States (Active_not_recruiting)
- Central Connecticut Neurosurgery and Spine — New Britian, Connecticut, United States (Recruiting)
- Yale Center for Clinical Investigation, Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
- Minimally Invasive Spine Center of South Florida — Miami, Florida, United States (Recruiting)
- Foundation for Orthopaedic Research and Education — Tampa, Florida, United States (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 (Active_not_recruiting)
- Twin Cities Orthopedics — Edina, Minnesota, United States (Active_not_recruiting)
- University Orthopedics Center — State College, Pennsylvania, United States (Recruiting)
- Texas Spine Consultants — Addison, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: jeff Feldhaus
- Email: jfeldhaus@msquaredassociates.com
- Phone: 13476694903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.