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NCT05603728Recruiting

Exactech Shoulder Post Market Clinical Follow-up Study

Exactech

Start Date

7/19/2007

Completion Date

12/31/2031

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 Criteria

Age Range: 21 years to No maximum

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)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Osteo Arthritis ShouldersOsteonecrosisRotator Cuff TearsRotator Cuff Tear ArthropathyAnkylosing SpondylitisPost-traumatic OsteoarthritisRheumatoid ArthritisFractureInfections

Locations

South County Orthopedic Specialists

Laguna Woods, California 92637

United States

Stanford Health Care

Redwood City, California 94063

United States

Alpine Orthopaedic Medical Group

Stockton, California 95204-5508

United States

Western Orthopaedics

Denver, Colorado 80218

United States

Orthopaedic and Spine Center of the Rockies

Fort Collins, Colorado 80525

United States

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida 32607

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Palm Beach Orthopaedic Institute

Palm Beach Gardens, Florida 33401

United States

Florida Atlantis Orthopedics

Palm Beach Gardens, Florida 33410

United States

Orthopaedic Medical Group of Tampa Bay

Tampa, Florida 33619

United States

Orthopedic and Sports Medicine

Augusta, Georgia 30909

United States

OrthoIllinois

Rockford, Illinois 61107

United States

Barrington Orthpedic Specialists

Schaumburg, Illinois 60195

United States

Henry Ford Health

Detroit, Michigan 48067

United States

Hospital for Joint Diseases - NYU Langone Health

New York, New York 10003

United States

Lenox Health Greenwich Village

New York, New York 10011

United States

Southeastern Sports Medicine and Orthopedics

Asheville, North Carolina 28803

United States

Duke Department of Orthopedic Surgery

Durham, North Carolina 27705

United States

Crystal Clinic Orthopaedic

Akron, Ohio 44333

United States

Charleston Orthopaedic Associates

Charleston, South Carolina 29414

United States

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina 29615

United States

Bone and Joint Institute of Tenessee

Franklin, Tennessee 37067

United States

Atlantic Orthopaedics Specialists

Virginia Beach, Virginia 23320

United States

Orthopaedic Associates of Wisconsin

Pewaukee, Wisconsin 53072

United States

St Joseph's Health Care

London, Ontario N6A 4V2

Canada

Clinique Chenieux

Limoges, 87039

France

Centre de l'arthrose

Mérignac, 33700

France

Clinique Mutualiste La Sagesse

Rennes, 35043

France

Policlinico Morgagni

Catania, 95125

Italy

Campolongo Hospital

Eboli, 84025

Italy

Circle Health Group

Reading, Berks RG2 7AU

United Kingdom

Yeovil District Hospital NHS Foundation Trust

Yeovil, Summerset BA21 4AT

United Kingdom

The Sulis Hospital Bath

Bath, BA2 8SQ

United Kingdom

Bedford Hospital

Bedford, MK42 9DJ

United Kingdom

Ipswich Hospital

Ipswich, IP4 5PD

United Kingdom

Leicester General Hospital

Leicester, LE5 4PW

United Kingdom

University Hospital South Manchester

Manchester, M23 9LT

United Kingdom

Nottingham University Hospital

Nottingham,

United Kingdom