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New shoulder implant tested for arthritis and rotator cuff tears

NCT ID NCT04431973

Disease control Sponsor: University Hospital, Tours 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a shoulder replacement device called the Medacta Shoulder System in 100 people with shoulder arthritis or rotator cuff tears. The goal is to see how well the implant works after 2 years, focusing on shoulder function, safety, and patient satisfaction. Participants receive the implant during surgery and are followed for up to 2 years.

What this could mean

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

Active substance
Medacta Shoulder System (reverse shoulder prosthesis)
What this could lead to
If successful, this could confirm that the Medacta Shoulder System provides reliable pain relief and improved shoulder function for people with severe shoulder conditions.
What could go wrong
This is a post-market study with no control group, so results may not prove superiority over other prostheses. Complications like infection or implant loosening 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.

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

About 100 people

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

Started

Sep 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

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 aged 18 to 87 ; * Patient with one of the following diseases: primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy; * Patient in need of a total shoulder prosthesis; * Patient affiliated with or beneficiary of a social security scheme; * Patient who has given written informed consent for the study. Exclusion Criteria: * Patient with malignant diseases; * Patient with known or suspected infections; * Patient with neurological deficits that may affect shoulder function; * Patient with known incompatibility or allergy to product materials; * Patient with previous open shoulder surgery (fracture sequelae, plate or nail, revision ...), treated for fractures, or suffering from rheumatoid arthritis (this does not concern patients treated by arthroscopy, or bone block); * Protected major patient; * Vulnerable person according to article L1121-6 of the Public Health Code; * Pregnant or breastfeeding woman or woman of childbearing age; * Impossibility to follow the consultation schedule planned in the study (planned move or mutation, etc...). Exclusion criteria : * Patient with malignant diseases on the day of surgery; * Patient with known incompatibility or allergy to product materials on the day of surgery; * Patient with known or suspected infections on the day of surgery.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, hip rotator cuff syndrome

As listed by the trial registrant

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

Shoulder prosthesis

Contacts and locations

Locations

  • Chu Angers

    Angers, France

  • Chu Rennes

    Rennes, France

  • Chu Tours

    Tours, France

  • Clinique Mutualiste la Sagesse

    Rennes, France

  • Polyclinique santé atlantique

    Saint-Herblain, France