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Clinical Trials in the USA / NCT05329129
Recruiting Observational

OssDsign® Spine Registry Study ("Propel")

NCT05329129 · tracked via the Priya Life Science USA tracker
Sponsor
OssDsign
Phase
Observational
Started
2022-03-23
Last updated
2026-10-28

Condition(s) studied

Degenerative Disc DiseaseSpinal Stenosis

Investigational drug(s) / intervention(s)

OssDsign® Catalyst

OssDsign® Catalyst: An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler

Study 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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
* 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

Primary outcome measure(s)

  • Rate of bone fusion — 12 months ± 60 days post-operative examination
    Assessment of the rate of bone fusion via Computerized Tomography (CT)/x-ray based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level.

Trial sites (16)

FacilityCityRegionStatus
Community Health Partners Neuroscience Fresno California Recruiting
Memorial Orthopaedic Surgical Group Long Beach California Recruiting
San Diego Neurosurgery San Diego California Terminated
Orthopedic Associates of Hartford Hartford Connecticut Recruiting
Central Connecticut Neurosurgery and Spine New Britian Connecticut Recruiting
Yale Center for Clinical Investigation, Yale School of Medicine New Haven Connecticut Active Not Recruiting
Minimally Invasive Spine Center of South Florida Miami Florida Recruiting
Foundation for Orthopaedic Research and Education Tampa Florida Active Not Recruiting
Northeast Georgia Medical Center Gainesville Georgia Active Not Recruiting
Carle Foundation Hospital, NeuroScience Institute Urbana Illinois Completed
Orthopaedic Institute of Western Kentucky Paducah Kentucky Completed
OrthoBethesda Research Foundation Bethesda Maryland Completed
Michigan Orthopaedic Surgeons Southfield Michigan Recruiting
Twin Cities Orthopedics Edina Minnesota Active Not Recruiting
University Orthopedics Center State College Pennsylvania Recruiting
Texas Spine Consultants Addison Texas Recruiting

Other trials for the same condition

Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain Active, not recruiting
Cervical Interbody Implant Study Enrolling by invitation
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc Active, not recruiting
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels Enrolling by invitation
Clinical Outcome Measure at Stryker Spine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05329129 on ClinicalTrials.gov ↗ ← All trials in the USA