RecruitingNCT05329129

OssDsign® Spine Registry Study ("Propel")

PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE

Sponsor

OssDsign

Enrollment

450 participants

Start Date

Mar 23, 2022

Study Type

OBSERVATIONAL

Conditions

Spinal Stenosis Degenerative Disc Disease

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This registry study tracks patients who have undergone spinal fusion surgery using OssDsign bone graft material, to collect real-world data on safety and healing outcomes over two years. You may be eligible if: - You are 21 years of age or older - You have been recommended for spinal fusion surgery - Your surgeon has chosen to use an OssDsign bone graft in your procedure - You are physically and mentally able to attend follow-up visits for 2 years - You are willing to sign informed consent You may NOT be eligible if: - You do not meet all of the inclusion criteria above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOssDsign® Catalyst

An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler

Locations(15)

Community Health Partners Neuroscience

Fresno, California, United States

Memorial Orthopaedic Surgical Group

Long Beach, California, United States

San Diego Neurosurgery

San Diego, California, United States

Orthopedic Associates of Hartford

Hartford, Connecticut, United States

Central Connecticut Neurosurgery and Spine

New Britian, Connecticut, United States

Yale Center for Clinical Investigation, Yale School of Medicine

New Haven, Connecticut, United States

Minimally Invasive Spine Center of South Florida

Miami, Florida, United States

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Carle Foundation Hospital, NeuroScience Institute

Urbana, Illinois, United States

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States

OrthoBethesda Research Foundation

Bethesda, Maryland, United States

Twin Cities Orthopedics

Edina, Minnesota, United States

University Orthopedics Center

State College, Pennsylvania, United States

Texas Spine Consultants

Addison, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05329129

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