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New shoulder implant study aims to ease severe arthritis and rotator cuff damage

NCT ID NCT03404778

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 175 people who receive a Biomet Comprehensive Reverse Shoulder implant to see how much their pain and shoulder function improve over one year and beyond. Participants have severe shoulder problems like arthritis or a torn rotator cuff that cannot be repaired. The goal is to measure pain relief and shoulder movement using standard medical scores.

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 175 people

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

Started

Mar 2010

Expected to finish

Dec 2036

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 in need of a reverse shoulder arthroplasty which receive the Biomet Comprehensive Reverse Shoulder and who meet all of the inclusion and none of the exclusion criteria.

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: * Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. * The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. * The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Exclusion Criteria: * Absolute contraindications include infection, sepsis, and osteomyelitis. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Osteoporosis. * Metabolic disorders which may impair bone formation. * Osteomalacia. * Distant foci of infections which may spread to the implant site. * 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 arthitis Rheumatoid arthritis without humeral metaphyseal defects

How to take part

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

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Acromion LLC

    Towson, Maryland, 21204, United States

  • Allina Health System DBA Sports and Orthopaedic Specialists

    Edina, Minnesota, 55439, United States

  • Joint Implant Surgeons

    New Albany, Ohio, 43054, 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.