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Shoulder implants tracked for 10 years in new study

NCT ID NCT04003311

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well two specific shoulder replacement parts work over time. It includes 146 adults who already had or will have shoulder replacement surgery. Researchers will check for problems and ask patients about their shoulder function for up to 10 years after surgery.

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 146 people

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

Started

Dec 2019

Expected to finish

Jul 2028

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

A consecutive series of subjects implanted with the Comprehensive Primary Micro Stem and/or the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads in primary and/or revision total shoulder arthroplasty according to the approved indications.

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: * Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads * Patient must be 18 years of age or older. * Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, * rheumatoid arthritis, * revision where other devices or treatments have failed, * correction of functional deformity, * fractures of the proximal humerus where other methods of treatment are deemed inadequate, * difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable or may be inadequate. Exclusion Criteria: * Absolute contraindications include infection, sepsis, and osteomyelitis. * Relative contraindications include: * 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 * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Patient is known to be pregnant or breastfeeding. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.

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Conditions

The condition(s) this trial relates to.

humerus fracture osteoarthritis rheumatoid arthritis Shoulder Fractures Shoulder Injuries Shoulder Pain

As listed by the trial registrant

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

Shoulder arthritis Shoulder disease Shoulder fractures Shoulder injuries Shoulder pain

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

  • Beaumont Health

    Royal Oak, Michigan, 48073, United States

  • Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont

    Burlington, Vermont, 05405, United States

  • Shoulder Clinic of Idaho

    Boise, Idaho, 83704, United States

  • University of Rochester

    Rochester, New York, 14642, United States

More trials for these conditions

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