Tapestry Rotator Cuff Repair PMCF

A Multi-Center, Prospective Post Market Clinical Follow-Up Evaluating Arthroscopic Rotator Cuff Repair Augmented With TAPESTRY® Biointegrative Implant

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.

Study Overview

• Status: Suspended
• Conditions: Rotator Cuff Injuries; Rotator Cuff Tears
• Intervention / Treatment: Device: Tapestry Biointegrative Implant

Detailed Description

The objectives of the study are to calculate the overall clinical success rate, the performance, and clinical benefits, and confirm the safety of the Tapestry RC Biointegrative Implant System.

• The clinical success will be evaluated by absence of rotator cuff re-tear.
• The performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Visual Analogue Scale (VAS), Constant-Murley Score (CMS), Single Assessment Numeric Evaluation (SANE), Return to Activity, Patient Satisfaction, EQ-5D-5L, and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration.
• The safety of the Tapestry RC Biointegrative Implant System will be assessed by monitoring the frequency and incidence of adverse events.

The primary endpoint of this study is defined by the rotator cuff re-tear rate post-operatively. This will be measured against the success criteria of the re-tear rate in 18.3% of cases at two years.

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91767
      • Premier Ortho & Trauma Specialists
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • UofL Health
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The American Shoulder and Elbow Surgeons (ASES) Score	The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.	Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
Constant-Murley Score (CMS)	The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.	Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
The Single Assessment Numeric Evaluation (SANE) Score	The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.	Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
EQ-5D-5L (EuroQol)	The 5-level EQ-5D (EQ-5D-5L) is a standardized self-assessed, health related quality of life questionnaire. It is composed of five questions with Likert scale response options (descriptive system) and a visual analog scale (EQ-VAS). The EQ-VAS asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively).	Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
Return to Work/Activity	The functional assessment of return to activity is evaluated by the time from discharge to return to work, driving, and sport.	6 weeks, 3-month, 6-month, 12-month 24-month post-operatively
Patient Satisfaction	It is a 5 choice questions asking for patient overall satisfaction to the operative shoulder, from very satisfied to very unsatisfied.	6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
Adverse Event	All adverse events reported throughout each subject's length of participation in the study are included.	Screening/Pre-Op, Op, Imme-Post-op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
MRI Sugaya Classification	The Sugaya classification will be used to determine rotator cuff integrity and characterization of retear (symptomatic/asymptomatic, size, shape). Sugaya classifies the integrity of the rotator cuff into five categories: Type I to Type V.	Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively
MRI Goutallier Classification	The Goutallier classification will be used to evaluate the rotator cuff quality by classifying the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade 0, indicating a completely normal muscles without any fatty streaks, to a grade 4 which indicates more fat is present than muscle	Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: EMBODY-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No