OssDsign® Spine Registry Study (“Propel”)

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Description

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.

Study Overview

Start Date
March 23, 2022
Completion Date
January 1, 2027
Enrollment
300
Date Posted
April 14, 2022
Gender
All

Locations

Full Address
Community Health Partners Neuroscience
Fresno, California 93720, United States

Orthopedic Associates of Hartford
Hartford, Connecticut 06102, United States

Yale Center for Clinical Investigation, Yale School of Medicine
New Haven, Connecticut 06519, United States

Minimally Invasive Spine Center of South Florida
Miami, Florida 33133, United States

Foundation for Orthopaedic Research and Education
Tampa, Florida 33607, United States

Northeast Georgia Medical Center
Gainesville, Georgia 30501, United States

Carle Foundation Hospital, NeuroScience Institute
Urbana, Illinois 61801, United States

OrthoBethesda Research Foundation
Bethesda, Maryland 20817, United States

Eligibility

Study Population
Patients diagnosed with as a candidate for spinal fusion surgery
Minimum Age (years)
21
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

Study Contact Info

Study Contact Name
Jeff Feldhaus
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
Detailed Description
This multi-center study (up to 10 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 300 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.
NCTid (if applicable)
NCT05329129