Rotator Cuff TearsNCT06287853
Tapestry Rotator Cuff Repair PMCF
An observational study of Rotator Cuff Tears and Rotator Cuff Injuries, run by Zimmer Biomet at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- Tapestry Biointegrative Implant
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Dec 2026to 30 Dec 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
UofL Health
Louisville, Kentucky, 40215
Premier Ortho & Trauma Specialists
Pomona, California, 91767
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Being tested
- Tapestry Biointegrative Implant
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapestry Biointegrative ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Partial Thickness Tear | Patient with a diagnosis of a symptomatic primary partial-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair. Receives: 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. Receives: Device: Tapestry Biointegrative Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-tear rate after arthroscopic rotator cuff repair
Assessed by MRI evaluation at 6 months post-operatively defined using Sugaya classification system.
Measured: 6-month Post-operatively
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start28 Dec 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Why it stopped: Sponsor has elected to place the Tapestry RC PMCF study on hold. The Tapestry RC product line is being enhanced, and we have chosen to delay data collection on this product until the new devices are available. Study is anticipated to resume in 2026.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287853
- Sponsor's protocol ID
- EMBODY-004
- Status last verified
- Nov 2025
- First submitted
- 23 Feb 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Post Market Clinical Follow-Up Evaluating Arthroscopic Rotator Cuff Repair Augmented With TAPESTRY® Biointegrative Implant
- ClinicalTrials.gov ID
- NCT06287853
- Acronym / sponsor ID
- EMBODY-004
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Sponsor has elected to place the Tapestry RC PMCF study on hold. The Tapestry RC product line is being enhanced, and we have chosen to delay data collection on this product until the new devices are available. Study is anticipated to resume in 2026.
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Thickness Tear | – | Device: Tapestry Biointegrative ImplantPatient with a diagnosis of a symptomatic primary partial-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair. |
| Full Thickness Tear | – | Device: Tapestry Biointegrative ImplantPatient with a diagnosis of a symptomatic primary full-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapestry Biointegrative ImplantThe 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. | Device | Full Thickness Tear, Partial Thickness Tear |
Primary outcome
Re-tear rate after arthroscopic rotator cuff repair
Time frame: 6-month Post-operatively
Assessed by MRI evaluation at 6 months post-operatively defined using Sugaya classification system.
9 secondary outcomes
The American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
Constant-Murley Score (CMS)
Time frame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
The Single Assessment Numeric Evaluation (SANE) Score
Time frame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
EQ-5D-5L (EuroQol)
Time frame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
Return to Work/Activity
Time frame: 6 weeks, 3-month, 6-month, 12-month 24-month post-operatively
Patient Satisfaction
Time frame: 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
Adverse Event
Time frame: Screening/Pre-Op, Op, Imme-Post-op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
MRI Sugaya Classification
Time frame: Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively
MRI Goutallier Classification
Time frame: Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears and Rotator Cuff Injuries, run by Zimmer Biomet at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-tear rate after arthroscopic rotator cuff repair (time frame: 6-month Post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.