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New shoulder implant under review for salvage replacements

NCT ID NCT05358574

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study follows 40 people who received a specific shoulder implant during a complex revision surgery. Researchers will track how long the implant lasts, any complications, and how well the shoulder works over 10 years. The goal is to confirm the implant is safe and effective for patients who need a second chance at shoulder replacement.

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 40 people

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

Started

Apr 2022

Expected to finish

Jul 2033

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

The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder Bipolar System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria 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: 1. The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible 2. Patient should have received the Anatomical Shoulder Bipolar System 3. Patient should have signed the Informed Consent Form 4. Patient is 18-100 years of age, inclusive 5. Patient is skeletally mature Exclusion Criteria: 1. Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule 2. Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them 3. Patient is known to be pregnant or breastfeeding 4. Musculoskeletal situation that enables the application of a regular hemi or total shoulder system 5. Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible 6. Patient's physical conditions that would impair achieving adequate implant support, and/or prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone). 7. Signs of infection 8. Non-functional deltoid muscle 9. Charcot's shoulder (neuroarthropathy) 10. Presence of significant injury to the upper brachial plexus 11. Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Helios ENDO-Klinik

    RECRUITING

    Hamburg, 22767, Germany

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