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New shoulder implant aims to cut Re-Tear rates after rotator cuff surgery

NCT ID NCT06287853

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a special implant called TAPESTRY that is placed during shoulder surgery to support healing of torn rotator cuff tendons. About 170 adults with partial or full-thickness tears will receive the implant and be followed for 6 months. The main goal is to see if the implant lowers the chance of the tendon tearing again, as seen on MRI scans.

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 170 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

The study population will include both males and females undergoing arthroscopic rotator cuff repair due to partial or full-thickness tears of the supraspinatus and/or infraspinatus tendon.

Ages

21 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: 1. Adult, 21 years and older; 2. Patient with a diagnosis of a symptomatic primary partial-thickness or full-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair that meets one of the following criteria: * Partial-thickness tear planned for standalone treatment (no surgical repair with sutures/suture anchors) with the Tapestry Biointegrative Implant, or * Full-thickness tear planned for treatment with the Tapestry Biointegrative Implant as an adjunct to surgical repair (single or double row repair with sutures/suture anchors); 3. Patient is able and willing to complete the protocol required follow-up; 4. Patient is able and willing to sign the IRB approved informed consent; 5. Independent of study participation, patient qualifies for arthroscopic rotator cuff repair and meets the approved indications for use of the commercially available Tapestry RC Biointegrative Implant System Exclusion Criteria: 1. Hypersensitivity to bovine-derived materials or poly(D,L-lactide) materials; 2. Patient with an irreparable or partially reparable rotator cuff tear; 3. Revision rotator cuff repair; 4. Off-label use of the study device; 5. Patient is known to be pregnant or nursing; 6. Patient is a prisoner; 7. Patient is a known alcohol or drug abuser; 8. Patient has a psychiatric illness, neurologic disorder, or cognitive deficit that will not allow for proper informed consent or compliance with study requirements; 9. Patient is unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications; 10. Patient is unwilling or unable to give consent or to comply with the follow-up program; 11. Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.

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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.

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Premier Ortho & Trauma Specialists

    Pomona, California, 91767, United States

  • UofL Health

    Louisville, Kentucky, 40215, United States

More trials for these conditions

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