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New implant aims to improve shoulder surgery outcomes

NCT ID NCT06857084

Disease control Sponsor: Smith & Nephew, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking up to 400 people who are having arthroscopic rotator cuff repair with a device called the REGENETEN Bioinductive Implant. The implant is placed to support healing of the torn tendon. Researchers will measure shoulder function, pain, and quality of life for two years after surgery. The goal is to see how well the implant works in real-world settings across multiple countries.

What this could mean

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

Active substance
REGENETEN Bioinductive Implant (a medical device used to support tendon healing)
What this could lead to
If successful, this could show that the REGENETEN implant improves shoulder function and reduces retear rates after rotator cuff surgery.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. The implant is already approved, so this study is mainly gathering real-world data rather than testing a new breakthrough.

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 400 people

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

Started

Oct 2020

Expected to finish

Dec 2029

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

Orthopaedic Clinics/practices

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: * Subject requires Arthroscopic rotator cuff repair (ARCR); * Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry. Exclusion Criteria: * Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse. * Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs); * Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.

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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 injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 4 countries. 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

  • Artemed Klinikum München Süd

    RECRUITING

    München, 81379, Germany

  • Burnley General Hospital

    RECRUITING

    Burnley, Lancashire, BB10 2PQ, United Kingdom

  • Burnley General Teaching Hospital

    RECRUITING

    Burnley, Lancashire, BB10 2PQ, United Kingdom

  • Cleveland Clinic London Hospital

    RECRUITING

    London, London, SW1X 7HY, United Kingdom

  • Grantham and District Hospital

    RECRUITING

    Grantham, Lincolnshire, NG31 8DG, United Kingdom

  • Malteser Waldkrankenhaus Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, Lancashire, M23 9LT, United Kingdom

  • Melbourne Orthopaedic Group

    RECRUITING

    Windsor, Victoria, 3181, Australia

  • OrthoMedicum Mittelhessen

    RECRUITING

    Stadtallendorf, 35260, Germany

  • Ospedale Israelitico

    RECRUITING

    Roma, Italy

  • Ospedale di Sassuolo

    RECRUITING

    Sassuolo, 41049, Italy

  • Regional General Hospital F. Miulli

    RECRUITING

    Acquaviva delle Fonti, Apulia, 70021, Italy

  • Schoen Klinik Dusseldorf

    RECRUITING

    Düsseldorf, 40549, Germany

  • Schoen Klinik Lorsch

    RECRUITING

    Lorsch, Rhine, 64653, Germany

  • Spire Harpenden Hospital

    RECRUITING

    Harpenden, Hertordshire, AL5 4BP, United Kingdom

  • Spire Montefiore

    RECRUITING

    Brighton, Hove, BN3 1RD, United Kingdom

  • Sporthopaedie Heidelberg

    RECRUITING

    Heidelberg, 69121, Germany

  • St. Anna Hospital

    RECRUITING

    Herne, 44649, Germany

  • Sulis Hospital Bath

    RECRUITING

    Bath, Somerset, BA2 8SF, United Kingdom

  • University College London Hospitals

    RECRUITING

    London, London, NW1 2BU, United Kingdom

  • West Hertfordshire Hospitals NHS Trust

    NOT_YET_RECRUITING

    Hertford, United Kingdom

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