RecruitingNCT05603728

Exactech Shoulder Post Market Clinical Follow-up Study

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Sponsor

Exactech

Enrollment

20,000 participants

Start Date

Jul 19, 2007

Study Type

OBSERVATIONAL

Conditions

Rheumatoid Arthritis Infections Ankylosing Spondylitis Fracture Osteonecrosis Rotator Cuff Tear Arthropathy Osteo Arthritis Shoulders Rotator Cuff Tears Post-traumatic Osteoarthritis

Summary

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This long-term follow-up study collects data on patients who have received or are receiving a shoulder replacement (arthroplasty) using an Exactech device. The goal is to monitor how well the implant performs over time and track any complications or need for revision surgery. **You may be eligible if...** - You are indicated for shoulder replacement surgery, or have already had one using an Exactech implant - Your bones are fully developed (skeletally mature) - Doctors expect you to live at least 2 years beyond your surgery - You are willing to attend follow-up visits and sign a consent form **You may NOT be eligible if...** - You have active infection in the joint or surrounding area - You have severe bone loss or muscle weakness that would prevent the implant from working properly - You have conditions that make surgery too risky - You are unwilling or unable to comply with follow-up visits 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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Locations(38)

South County Orthopedic Specialists

Laguna Woods, California, United States

Stanford Health Care

Redwood City, California, United States

Alpine Orthopaedic Medical Group

Stockton, California, United States

Western Orthopaedics

Denver, Colorado, United States

Orthopaedic and Spine Center of the Rockies

Fort Collins, Colorado, United States

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Palm Beach Orthopaedic Institute

Palm Beach Gardens, Florida, United States

Florida Atlantis Orthopedics

Palm Beach Gardens, Florida, United States

Orthopaedic Medical Group of Tampa Bay

Tampa, Florida, United States

Orthopedic and Sports Medicine

Augusta, Georgia, United States

OrthoIllinois

Rockford, Illinois, United States

Barrington Orthpedic Specialists

Schaumburg, Illinois, United States

Henry Ford Health

Detroit, Michigan, United States

Hospital for Joint Diseases - NYU Langone Health

New York, New York, United States

Lenox Health Greenwich Village

New York, New York, United States

Southeastern Sports Medicine and Orthopedics

Asheville, North Carolina, United States

Duke Department of Orthopedic Surgery

Durham, North Carolina, United States

Crystal Clinic Orthopaedic

Akron, Ohio, United States

Charleston Orthopaedic Associates

Charleston, South Carolina, United States

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, United States

Bone and Joint Institute of Tenessee

Franklin, Tennessee, United States

Atlantic Orthopaedics Specialists

Virginia Beach, Virginia, United States

Orthopaedic Associates of Wisconsin

Pewaukee, Wisconsin, United States

St Joseph's Health Care

London, Ontario, Canada

Clinique Chenieux

Limoges, France

Centre de l'arthrose

Mérignac, France

Clinique Mutualiste La Sagesse

Rennes, France

Policlinico Morgagni

Catania, Italy

Campolongo Hospital

Eboli, Italy

Circle Health Group

Reading, Berks, United Kingdom

Yeovil District Hospital NHS Foundation Trust

Yeovil, Summerset, United Kingdom

The Sulis Hospital Bath

Bath, United Kingdom

Bedford Hospital

Bedford, United Kingdom

Ipswich Hospital

Ipswich, United Kingdom

Leicester General Hospital

Leicester, United Kingdom

University Hospital South Manchester

Manchester, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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