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New shoulder implant under scrutiny: will it hold up?

NCT ID NCT03726554

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study follows 99 people who received a specific shoulder replacement system to see how well it works and if it is safe. Participants had severe shoulder arthritis, a torn rotator cuff, or a failed prior shoulder replacement. The main goal is to track how long the implant lasts without needing to be removed.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

99 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Feb 2030

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.

Ages

18 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 must be 18 years of age or older. * Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid. * Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. * Patient must be able and willing to complete the protocol required follow-up. * Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent. Exclusion Criteria: * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Patient presents with osteoporosis. * Patient has a metabolic disorder that may impair bone formation. * Patient has osteomalacia. * Patient has distant foci of infections which may spread to the implant site. * Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis rheumatoid arthritis rotator cuff syndrome

As listed by the trial registrant

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

Arthropathy of shoulder region Grossly deficient rotator cuff Osteoarthritis of the shoulder Post traumatic arthritis Rheumatoid arthritis without humeral metaphyseal defects

Contacts and locations

Locations

  • Andrews Research and Education Foundation

    Gulf Breeze, Florida, 32561, United States

  • Campbell Foundation

    Germantown, Tennessee, 38138, United States

  • Norton Orthopedic Specialists

    Louisville, Kentucky, 40241, United States

  • The Rector and Visitors of the University of Virginia

    Charlottesville, Virginia, 22903, United States

  • The Research Foundation for the State University of New York

    Buffalo, New York, 14215, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

More trials for these conditions

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