Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New implant aims to fix torn shoulder tendons

NCT ID NCT05721560

Disease control Sponsor: BAAT Medical Products B.V. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a new device called SINEFIX to repair small rotator cuff tears (up to 2 cm) in 9 adults. The implant is placed during keyhole surgery to reattach the torn tendon to the bone. Researchers will use MRI scans to check if the tendon heals properly and if there are any complications like re-tears or implant dislocation.

What this could mean

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

Active substance
SINEFIX implant (a device used to reattach torn rotator cuff tendons during arthroscopic surgery)
What this could lead to
If successful, this implant could offer a more reliable way to repair small rotator cuff tears, potentially reducing re-tear rates and improving shoulder function.
What could go wrong
This is a very small early study (9 people) with no comparison group, so results may not apply broadly. The implant could dislocate or cause bursitis, and long-term benefits are unknown.

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

9 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Jun 2026

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.

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: * Patient indicated for surgical repair of the rotator cuff tear according to current guidelines * Patient aged 18 years or older * Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral) * Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior) Exclusion Criteria: * Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder * History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments * Inflammatory arthropathies * Subject with a contraindication/non-compliance for MRI examination * Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule * Pregnant and breastfeeding woman

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rotator cuff tears are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

Rotator cuff tears (RCTS)

Contacts and locations

Locations

  • Orthopädisch Chirurgisches Centrum (OCC)

    Tübingen, 72074, Germany

More trials for these conditions

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