Clinical trial NCT06287853: Tapestry Rotator Cuff Repair PMCF
Official title: A Multi-Center, Prospective Post Market Clinical Follow-Up Evaluating Arthroscopic Rotator Cuff Repair Augmented With TAPESTRY® Biointegrative Implant
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Re-tear rate after arthroscopic rotator cuff repair
timeFrame: 6-month Post-operatively
Secondary outcomes:
measure: The American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
measure: Constant-Murley Score (CMS)
timeFrame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
measure: The Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
measure: EQ-5D-5L (EuroQol)
timeFrame: Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
measure: Return to Work/Activity
timeFrame: 6 weeks, 3-month, 6-month, 12-month 24-month post-operatively
measure: Patient Satisfaction
timeFrame: 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
measure: Adverse Event
timeFrame: Screening/Pre-Op, Op, Imme-Post-op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively
measure: MRI Sugaya Classification
timeFrame: Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively
measure: MRI Goutallier Classification
timeFrame: Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Premier Ortho & Trauma Specialists
state: California
city: Louisville
country: United States
facility: UofL Health
state: Kentucky
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
Study officials:
References: