OssDsign® Spine Registry Study ("Propel")
Start Date
3/23/2022
Completion Date
4/1/2030
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.
Detailed Description
This multi-center study (up to 25 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 750 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.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
OssDsign® Catalyst
Conditions
Locations
Community Health Partners Neuroscience
Fresno, California 93720
United States
Memorial Orthopaedic Surgical Group
Long Beach, California 90806
United States
San Diego Neurosurgery
San Diego, California 92024
United States
Orthopedic Associates of Hartford
Hartford, Connecticut 06102
United States
Central Connecticut Neurosurgery and Spine
New Britian, Connecticut 06051
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
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky 42001
United States
OrthoBethesda Research Foundation
Bethesda, Maryland 20817
United States
Twin Cities Orthopedics
Edina, Minnesota 55435
United States
University Orthopedics Center
State College, Pennsylvania 16801
United States
Texas Spine Consultants
Addison, Texas 75001
United States