Tapestry Rotator Cuff Repair PMCF

NCT06287853 | Suspended FDA Device

• 1 other identifier: EMBODY-004
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (1)

• Re-tear rate after arthroscopic rotator cuff repair

  Assessed by MRI evaluation at 6 months post-operatively defined using Sugaya classification system.

  6-month Post-operatively

Secondary Outcomes (9)

• The American Shoulder and Elbow Surgeons (ASES) Score

  Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively

• Constant-Murley Score (CMS)

  Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively

• The Single Assessment Numeric Evaluation (SANE) Score

  Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively

• EQ-5D-5L (EuroQol)

  Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively

• Return to Work/Activity

  6 weeks, 3-month, 6-month, 12-month 24-month post-operatively

Study Arms (2)

Partial Thickness Tear

Patient with a diagnosis of a symptomatic primary partial-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair.

Device: Tapestry Biointegrative Implant

Full Thickness Tear

Patient with a diagnosis of a symptomatic primary full-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair.

Device: Tapestry Biointegrative Implant

Interventions

Tapestry Biointegrative Implant DEVICE

The Tapestry RC Biointegrative Implant System is an arthroscopic delivery and fixation system intended for tendon augmentation with Tapestry Biointegrative Implant during arthroscopic rotator cuff (RC) repair. The system combines the biointegrative collagen-based implant (Tapestry Biointegrative Implant) with bioabsorbable fixation ( Bioabsorbable Anchors). Tapestry Biointegrative Implant is a collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues.

Full Thickness Tear; Partial Thickness Tear

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Premier Ortho & Trauma Specialists

Pomona, California, 91767, United States

Location

UofL Health

Louisville, Kentucky, 40215, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start (Estimated): December 28, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (3)