Tapestry Rotator Cuff Repair PMCF

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Conditions studied: Rotator Cuff Tears, Rotator Cuff Injuries

In brief

The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor.

Key facts

Study ID

NCT06287853

Run by

Zimmer Biomet

People needed

170

Starts

2026-12-28

Expected to finish

2030-12-30

Last updated by the study team

2025-11-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult, 21 years and older;
• 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);
• Patient is able and willing to complete the protocol required follow-up;
• Patient is able and willing to sign the IRB approved informed consent;
• 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

You may not qualify if…

• Hypersensitivity to bovine-derived materials or poly(D,L-lactide) materials;
• Patient with an irreparable or partially reparable rotator cuff tear;
• Revision rotator cuff repair;
• Off-label use of the study device;
• Patient is known to be pregnant or nursing;
• Patient is a prisoner;
• Patient is a known alcohol or drug abuser;
• Patient has a psychiatric illness, neurologic disorder, or cognitive deficit that will not allow for proper informed consent or compliance with study requirements;
• Patient is unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
• Patient is unwilling or unable to give consent or to comply with the follow-up program;
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.

Where it is running

• Premier Ortho & Trauma Specialists — Pomona, California, United States
• UofL Health — Louisville, Kentucky, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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