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RECRUITING

NCT05603728

Exactech Shoulder Post Market Clinical Follow-up Study

Sponsor: Exactech

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20000

Start Date

2007-07-19

Completion Date

2031-12-31

Last Updated

2025-12-15

Healthy Volunteers

Conditions

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

Inclusion Criteria: * Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty) * Patient is skeletelly mature * Patient is expected to survive at least 2 years beyond surgery * Patient is willing to participate by complying with pre- and postoperative visit requirements * Patient is willing and able to read and sign a study informed consent form Exclusion Criteria: * Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * Medial humeral bone loss resulting in compromised humeral stem fixation * Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation * Neuromuscular disorders that do not allow control of the joint * Significant injury to the brachial plexus * Non-functional deltoid muscles * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * The patient is unwilling or unable to comply with the post-operative care instructions * Alcohol, drug, or other subtance abuse * Any disease state that could adversaly affect the function or longevity of the implant * Patient is pregnant * Patient is a prisoner * Patient is contraindicated for the surgery * Revision cases in which a stemmed humeral component was used (Stemless Shoulder System) * Metal allergy or sensitivity to the implants materials (Stemless Shoulder System) * Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System) * Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

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