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Exactech Shoulder Post Market Clinical Follow-up Study

NCT ID: NCT05603728
Registry status: Recruiting
Study type: Observational
Sponsor: Exactech
Conditions: Ankylosing Spondylitis, Fracture, Infections, Osteo Arthritis Shoulders, Osteonecrosis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Rotator Cuff Tear Arthropathy, Rotator Cuff Tears

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 20000 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: 21 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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)

Study locations

40 study locations are listed.

Recruiting site status is explicitly provided for 40 locations; 40 are listed as Recruiting.

Countries: Canada, France, Germany, Italy, United Kingdom, United States

Ontario, Canada: 1
Berks, United Kingdom: 1
Summerset, United Kingdom: 1
California, United States: 3
Colorado, United States: 2
Florida, United States: 5
Georgia, United States: 1
Illinois, United States: 2
Michigan, United States: 1
New York, United States: 2
North Carolina, United States: 2
Ohio, United States: 1
South Carolina, United States: 2
Tennessee, United States: 1
Virginia, United States: 1
Wisconsin, United States: 1

Sample of listed locations

St Joseph's Health Care — London, Ontario, N6A 4V2, Canada — Recruiting
Clinique Belledone — Grenoble, 38000, France — Recruiting
Centre de l'arthrose — Mérignac, 33700, France — Recruiting
Clinique Mutualiste La Sagesse — Rennes, 35043, France — Recruiting
Malteser Waldkrankenhaus Erlangen — Erlangen, 91054, Germany — Recruiting
Orthopadische Praxisklinik Von Vincke — Münster, 48143, Germany — Recruiting
Policlinico Morgagni — Catania, 95125, Italy — Recruiting
Campolongo Hospital — Eboli, 84025, Italy — Recruiting
Circle Health Group — Reading, Berks, RG2 7AU, United Kingdom — Recruiting
Yeovil District Hospital NHS Foundation Trust — Yeovil, Summerset, BA21 4AT, United Kingdom — Recruiting
The Sulis Hospital Bath — Bath, BA2 8SQ, United Kingdom — Recruiting
Bedford Hospital — Bedford, MK42 9DJ, United Kingdom — Recruiting
Ipswich Hospital — Ipswich, IP4 5PD, United Kingdom — Recruiting
Leicester General Hospital — Leicester, LE5 4PW, United Kingdom — Recruiting
University Hospital South Manchester — Manchester, M23 9LT, United Kingdom — Recruiting
Nottingham University Hospital — Nottingham, United Kingdom — Recruiting
South County Orthopedic Specialists — Laguna Woods, California, 92637, United States — Recruiting
Stanford Health Care — Redwood City, California, 94063, United States — Recruiting
Alpine Orthopaedic Medical Group — Stockton, California, 95204-5508, United States — Recruiting
Western Orthopaedics — Denver, Colorado, 80218, United States — Recruiting
Orthopaedic and Spine Center of the Rockies — Fort Collins, Colorado, 80525, United States — Recruiting
UF Health Orthopaedics and Sports Medicine Institute — Gainesville, Florida, 32607, United States — Recruiting
Mayo Clinic — Jacksonville, Florida, 32224, United States — Recruiting
Florida Atlantis Orthopedics — Palm Beach Gardens, Florida, 33410, United States — Recruiting
Orthopaedic Medical Group of Tampa Bay — Tampa, Florida, 33619, United States — Recruiting

Study details

Start date: July 19, 2007
Primary completion date: December 31, 2030
Completion date: December 31, 2031
First posted: November 3, 2022

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05603728
Registry last updated: September 17, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT05603728 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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