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 collagen patch aims to speed up shoulder tear recovery

NCT ID NCT05444465

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tests a special collagen implant (REGENETEN) for people with partial-thickness rotator cuff tears. The goal is to see if it helps patients return to daily activities faster than the standard surgical repair. About 234 adults who have not improved after 3 months of other treatments will take part.

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 234 people

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

Started

Aug 2022

Expected to finish

Jun 2028

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: * The subject must provide written informed consent. * Subject is \> eighteen (18) years of age (no upper limit). * Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus. * Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear. * Subject willing and able to make all required study visits. * Subject able to follow instructions and deemed capable of completing all study questionnaires. Exclusion Criteria: * Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system. * Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation. * Subjects with Samilson-Prieto osteoarthritis grade 2 and greater. * Subjects with current or prior infection of the ipsilateral shoulder. * Subjects with known hypersensitivity to bovine-derived materials. * Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)). * Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE). * Subjects with a planned surgery on the contra-lateral shoulder within the study period. * Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery. * Subjects with a full thickness rotator cuff tear. * Subjects with a subscapularis tear requiring repair. * Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP). * Subjects requiring a concomitant os acromiale fixation procedure. * Subjects with glenohumeral joint instability (multiple dislocations/subluxations). * Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., \> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head. * Subjects with neurologic conditions effecting either upper extremity. * Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications. * Subjects who are pregnant or breast feeding. * Subjects who are currently involved in any injury litigation relating to the index shoulder. * Subjects with current workers compensation claim. * Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study. * Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation. * 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 study including mental illness, mental retardation, 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). * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55. * Subjects who have participated previously in this clinical trial and who have healed or been withdrawn * Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rotator cuff injuries 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 injuries

How to take part

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

  1. The places running it

    13 sites in 6 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

  • Access Orthopaedics

    RECRUITING

    Calgary, Alberta, T2R 2G5, Canada

  • Ashford & St Peter's Hospitals NHS Foundation Trust

    RECRUITING

    Chertsey, Surrey, KT16 0PZ, United Kingdom

  • Cleveland Clinic - Sports Health

    WITHDRAWN

    Garfield Heights, Ohio, 44125, United States

  • Fondazione Policlinico Universitario Campus Bio-Medico

    RECRUITING

    Roma, Italy

  • Harbin Clinic

    RECRUITING

    Rome, Georgia, 30165, United States

  • Hospital Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Houston Methodist The Woodlands

    WITHDRAWN

    The Woodlands, Texas, 77385, United States

  • IRCCS Istituto Ortopedico Galeazzi,

    RECRUITING

    Milan, Italy

  • Memorial Medical Center

    WITHDRAWN

    Ashland, Wisconsin, 54806, United States

  • North Bristol NHS Trust

    RECRUITING

    Bristol, United Kingdom

  • Northern Care Alliance NHS Foundation Trust

    WITHDRAWN

    Salford, M6 8HD, United Kingdom

  • OrthoIllinois LTD

    RECRUITING

    Rockford, Illinois, 61107, United States

  • OrthoSport Victoria

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Pan Am Clinic

    ACTIVE_NOT_RECRUITING

    Winnipeg, Manitoba, Canada

  • Research St. Joseph's

    RECRUITING

    Hamilton, Ontario, Canada

  • Sinai Hospital Baltimore

    WITHDRAWN

    Baltimore, Maryland, 21215, United States

  • Sulis Hospital

    RECRUITING

    Bath, United Kingdom

  • Texas Orthopedic Specialists

    ACTIVE_NOT_RECRUITING

    Bedford, Texas, 76021, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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