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New shoulder implant tracked for 10 years in 300 patients

NCT ID NCT05067543

Disease control Sponsor: Stryker Trauma and Extremities 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study is testing a shoulder replacement device in 300 people with shoulder arthritis, bone death, or rotator cuff tears. Participants receive the implant and are followed for 10 years to see how well it works and if it is safe. The goal is to improve pain and shoulder function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tornier Perform Humeral - Stem shoulder implant
What this could lead to
If successful, this implant could provide a reliable option for shoulder replacement, improving pain and function for years.
What could go wrong
This is a post-market study, not a new breakthrough. Results may vary by patient, and long-term complications like implant loosening or infection are possible.

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 300 people

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

Started

Sep 2021

Expected to finish

Dec 2037

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 intended for the total or partial replacement of the glenohumeral articulation.

Ages

18 years and older

Sex

Anyone

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: * 18 years or older at the time of the informed consent or non-opposition (when applicable). * Informed and willing to sign an informed consent form approved by IRB or EC (when applicable). * Willing and able to comply with the requirements of the study protocol. * Considered a candidate for shoulder arthroplasty using a study device. * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements Exclusion Criteria: * Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times) * Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm). * Active local or systemic infection, sepsis, or osteomyelitis * Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid * Significant injury to the brachial plexus * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components * Neuromuscular disease (e.g., joint neuropathy) * Patient with known allergy to one of the product materials * Metabolic disorders which may impair bone formation * Patient pregnancy * Planned for two-stage surgery

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Conditions

The condition(s) this trial relates to.

avascular necrosis osteoarthritis osteonecrosis rotator cuff syndrome Rotator Cuff Tear Arthropathy

As listed by the trial registrant

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

Avascular necrosis Osteoarthritis shoulder Post-traumatic arthrosis of other joints, shoulder region Rotator cuff tear arthropathy

How to take part

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

  1. The places running it

    5 sites. 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

  • Baptist Healthcare

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Mayo Clinic

    TERMINATED

    Rochester, Minnesota, 55905, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Orthopedic Center Santy

    ACTIVE_NOT_RECRUITING

    Lyon, 69008, France

  • Orthopedic Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Roth McFarlane Hand and Upper Limb Centre

    ACTIVE_NOT_RECRUITING

    London, Ontario, N6A 4L6, Canada

  • Schulthess Klinik

    ACTIVE_NOT_RECRUITING

    Zurich, CH-8008, Switzerland

  • Summit Orthopedics

    RECRUITING

    Eagan, Minnesota, 55121, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Washington University

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Wrightington Hospital

    ACTIVE_NOT_RECRUITING

    Wigan, Lancashire, WN6 9EP, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.