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New shoulder implant under real-world scrutiny: will it hold up?

NCT ID NCT07678034

Disease control Sponsor: TIPMED Medical Device Manufacturing Ltd. Co. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study follows adults who have received a Tipmed shoulder replacement to see how well the implant works and if any problems arise over the first year. Participants have conditions like severe arthritis, rotator cuff damage, or a broken shoulder bone. Researchers track shoulder function and any complications to confirm the device is safe and effective in routine care.

What this could mean

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

Active substance
Tipmed™ Shoulder Prosthesis System (reverse shoulder or hemiarthroplasty implant)
What this could lead to
If successful, this study could confirm that the Tipmed shoulder implant is safe and effective for everyday use, helping people with severe shoulder problems regain function.
What could go wrong
This is an observational study with only 54 participants, so results may not apply to everyone. 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 54 people

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

Started

Jun 2025

Expected to finish

Jun 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.

Who is studied

The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone either reverse shoulder arthroplasty or shoulder hemiarthroplasty at the participating multi-center orthopedic clinics. The study population is stratified into two distinct clinical cohorts representing individuals whose surgical treatment involved the standard clinical implantation of the Tipmed™ Shoulder Prosthesis System component options under specific anatomical configurations. Eligible individuals who are legally competent and provide written informed consent to allow their routine clinical findings to be documented for the study will be consecutively enrolled.

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: * Individuals aged 18 years and older, * Male or female participants, * Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication, * Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized. * Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship). * Participants who have voluntarily signed the written Informed Consent Form (ICF). Exclusion Criteria: * Concurrent participation in any other interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

arthropathy avascular necrosis humerus fracture osteoarthritis osteonecrosis rheumatoid arthritis rotator cuff syndrome

As listed by the trial registrant

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

Avascular necrosis Glenohumeral osteoarthritis Proximal humerus fracture Rheumatoid arthritis Rotator cuff arthropathy

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

    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

  • Dokuz Eylül University Research and Application Hospital

    NOT_YET_RECRUITING

    Izmir, 35340, Turkey (Türkiye)

  • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital

    RECRUITING

    Balıkesir, 10100, Turkey (Türkiye)

  • Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital

    NOT_YET_RECRUITING

    Istanbul, 34303, Turkey (Türkiye)

  • Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital

    NOT_YET_RECRUITING

    Izmir, 35140, Turkey (Türkiye)

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