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NCT05329129Recruiting

OssDsign® Spine Registry Study ("Propel")

OssDsign

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

* 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

Interventions

DEVICE

OssDsign® Catalyst

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Conditions

Degenerative Disc DiseaseSpinal Stenosis

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