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Massive shoulder replacement study tracks 20,000 patients for over a decade

NCT ID NCT05603728

Knowledge-focused Sponsor: Exactech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study is tracking 20,000 people who have had or will have shoulder replacement surgery to see how well the implants work over at least 10 years. Researchers will measure pain, daily function, and strength using standard shoulder scores. The goal is to better understand the long-term safety and performance of shoulder replacements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2007

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis bone fracture humerus fracture Infections infectious disease osteoarthritis osteonecrosis rheumatoid arthritis Rotator Cuff Injuries rotator cuff syndrome Rotator Cuff Tear Arthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis Fracture Infections Osteo arthritis shoulders Osteonecrosis Post-traumatic osteoarthritis Rheumatoid arthritis Rotator cuff tear arthropathy Rotator cuff tears

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alpine Orthopaedic Medical Group

    RECRUITING

    Stockton, California, 95204-5508, United States

  • Atlantic Orthopaedics Specialists

    RECRUITING

    Virginia Beach, Virginia, 23320, United States

  • Barrington Orthpedic Specialists

    RECRUITING

    Schaumburg, Illinois, 60195, United States

  • Bedford Hospital

    RECRUITING

    Bedford, MK42 9DJ, United Kingdom

  • Bone and Joint Institute of Tenessee

    RECRUITING

    Franklin, Tennessee, 37067, United States

  • Campolongo Hospital

    RECRUITING

    Eboli, 84025, Italy

  • Centre de l'arthrose

    RECRUITING

    Mérignac, 33700, France

  • Charleston Orthopaedic Associates

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Circle Health Group

    RECRUITING

    Reading, Berks, RG2 7AU, United Kingdom

  • Clinique Belledone

    RECRUITING

    Grenoble, 38000, France

  • Clinique Mutualiste La Sagesse

    RECRUITING

    Rennes, 35043, France

  • Crystal Clinic Orthopaedic

    RECRUITING

    Akron, Ohio, 44333, United States

  • Duke Department of Orthopedic Surgery

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Florida Atlantis Orthopedics

    RECRUITING

    Palm Beach Gardens, Florida, 33410, United States

  • HSS Florida

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48067, United States

  • Hospital for Joint Diseases - NYU Langone Health

    RECRUITING

    New York, New York, 10003, United States

  • Ipswich Hospital

    RECRUITING

    Ipswich, IP4 5PD, United Kingdom

  • Leicester General Hospital

    RECRUITING

    Leicester, LE5 4PW, United Kingdom

  • Lenox Health Greenwich Village

    RECRUITING

    New York, New York, 10011, United States

  • Malteser Waldkrankenhaus Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Nottingham University Hospital

    RECRUITING

    Nottingham, United Kingdom

  • OrthoIllinois

    RECRUITING

    Rockford, Illinois, 61107, United States

  • Orthopadische Praxisklinik Von Vincke

    RECRUITING

    Münster, 48143, Germany

  • Orthopaedic Associates of Wisconsin

    RECRUITING

    Pewaukee, Wisconsin, 53072, United States

  • Orthopaedic Medical Group of Tampa Bay

    RECRUITING

    Tampa, Florida, 33619, United States

  • Orthopaedic and Spine Center of the Rockies

    RECRUITING

    Fort Collins, Colorado, 80525, United States

  • Orthopedic and Sports Medicine

    RECRUITING

    Augusta, Georgia, 30909, United States

  • Policlinico Morgagni

    RECRUITING

    Catania, 95125, Italy

  • South County Orthopedic Specialists

    RECRUITING

    Laguna Woods, California, 92637, United States

  • Southeastern Sports Medicine and Orthopedics

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • St Joseph's Health Care

    RECRUITING

    London, Ontario, N6A 4V2, Canada

  • Stanford Health Care

    RECRUITING

    Redwood City, California, 94063, United States

  • Steadman Hawkins Clinic of the Carolinas

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • The Sulis Hospital Bath

    RECRUITING

    Bath, BA2 8SQ, United Kingdom

  • UF Health Orthopaedics and Sports Medicine Institute

    RECRUITING

    Gainesville, Florida, 32607, United States

  • University Hospital South Manchester

    RECRUITING

    Manchester, M23 9LT, United Kingdom

  • Western Orthopaedics

    RECRUITING

    Denver, Colorado, 80218, United States

  • Yeovil District Hospital NHS Foundation Trust

    RECRUITING

    Yeovil, Summerset, BA21 4AT, United Kingdom

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