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New shoulder implant under watch: how well does it last?

NCT ID NCT05002335

Knowledge-focused Sponsor: Medacta International SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 200 adults who received the Medacta Shoulder System to treat various shoulder issues like arthritis, fractures, or rotator cuff problems. The main goal is to see how long the implant lasts and how well the shoulder works after surgery. It is a post-market check to ensure the device performs safely and effectively.

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 200 people

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

Started

Oct 2020

Expected to finish

Dec 2027

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 requiring Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

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: * Patients older than 18 years * Patient with one of the following diagnosis: 1. Primary osteoarthritis 2. Secondary osteoarthritis 3. Cuff tear arthropathy; insufficient rotator cuff 4. Acute fracture (\<21d) 5. Rheumatoid or inflammatory arthritis 6. Avascular necrosis 7. Other posttraumatic condition 8. Revision of shoulder arthroplasty Exclusion Criteria: * Patients with malignant diseases (at the time of surgery) * Patients with proven or suspect infections (at the time of surgery) * Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery) * Patients with known incompatibility or allergy to products materials (at the time of surgery)

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Conditions

The condition(s) this trial relates to.

arthritic joint disease avascular necrosis bone fracture osteoarthritis osteonecrosis rheumatoid arthritis rotator cuff syndrome Rotator Cuff Tear Arthropathy

As listed by the trial registrant

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

Avascular necrosis Fracture Primary osteoarthritis Revision of shoulder arthroplasty Rheumatoid arthritis shoulder Rotator cuff tear arthropathy Secondary osteoarthritis

Contacts and locations

Locations

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • AZ Sint-Lucas

    Bruges, 8310, Belgium

  • Clinique St-Luc Bouge

    Namur, 5004, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.