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New shoulder implant MIRAI put to the test in 76 patients

NCT ID NCT05128500

Disease control Sponsor: Permedica spa 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study followed 76 adults who received a total shoulder replacement using the MIRAI modular prosthesis. Researchers measured how well the shoulder functioned and how stable the implant was over five years. The goal was to see if the implant helps patients move better and lasts without major problems.

What this could mean

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

Active substance
MIRAI Modular Shoulder Prosthesis System (a shoulder replacement implant)
What this could lead to
If successful, this could confirm that the MIRAI shoulder implant is a safe and effective option for people needing shoulder replacement, helping them regain movement and reduce pain.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove the implant is better than others. Also, 5 years is medium-term; longer follow-up is needed to know how long the implant truly lasts.

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

76 people

The number who actually took part.

Started

Jul 2019

Finished

Jan 2025

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 who are about to undergo a primary total shoulder arthroplasty in daily clinical practice, referring to one of the project investigator at the study site will be proposed to partecipate to the study.

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: * both genders * at least 18 years old of age * undergoing a primary total shoulder arthroplasty with MIRAI® Prosthesis System (anatomic or reverse, stemless or stemmed). * Signed informed consent Exclusion Criteria: * Patients requiring a revision shoulder arthroplasty * Persistent chronic or acute infections and all septic conditions * Persistent osteomyelitis local or systemic * Allergy or hypersensitivity to the substances contained in the materials of the implanted components * Acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle * Inadequate bone structure which cannot guarantee stability to the prosthetic components * Several vascular, nerve or muscular disorders, which compromise related extremities * Marked osteoporosis, osteomalacia * Hypotrophy of the periarticular soft tissues * Dysmetabolic diseases such as, for example, kidney failure or systemic diseases * Muscular insufficiency * Active neoplastic or metastatic diseases * Any other clinical or physical condition that can invalidate the surgery, the rehabilitation or the prosthesis stability * Patient unwilling or unable to undergo the rehabilitation or to return to follow-up visits * Women in pregnancy, childbearing potential or breastfeeding * Involvement in other ongoing studies or clinical trial.

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Conditions

The condition(s) this trial relates to.

arthropathy avascular necrosis osteoarthritis psoriatic arthritis rheumatoid arthritis rotator cuff syndrome Rotator Cuff Tear Arthropathy Shoulder Fractures

As listed by the trial registrant

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

Avascular necrosis of humerus Cuff tear arthropathy Fracture, shoulder Primary osteoarthritis Psoriatic arthritis Rheumatoid arthritis shoulder Secondary osteoarthritis Shoulder osteoarthritis

Contacts and locations

Locations

  • Krankenhaus Reinbek St. Adolf-Stilt

    Reinbek, Germany

  • Orthopädische Klinik Luzern - OKL

    Lucerne, Switzerland

  • ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre

    Feltre, 32032, Italy

  • go:h - Gelenkchirurgie Orthopädie: Hannover

    Hanover, Germany

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