Clinical trial Recruiting at 8 sites Observational Ages 21 and up

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 typeObservational
Ages21 Years and up
SexAll
Enrollment450 (estimated)
SponsorOssDsign
Industry-sponsored
Locations16 sites (Fresno, California and 15 other locations)
StatusRecruiting
StartedMarch 23, 2022
Main results expectedMarch 23, 2030
Study endsApril 1, 2030
Registry record updatedOctober 28, 2026
Trial IDNCT05329129 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.