Rotator Cuff Injuries, Rotator Cuff Tears
Conditions
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.
Interventions
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.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-tear rate after arthroscopic rotator cuff repair | 6-month Post-operatively | Assessed by MRI evaluation at 6 months post-operatively defined using Sugaya classification system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The American Shoulder and Elbow Surgeons (ASES) Score | Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively | 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. |
| Constant-Murley Score (CMS) | Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively | 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. |
| The Single Assessment Numeric Evaluation (SANE) Score | Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively | 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. |
| EQ-5D-5L (EuroQol) | Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively | 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). |
| Adverse Event | Screening/Pre-Op, Op, Imme-Post-op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively | All adverse events reported throughout each subject's length of participation in the study are included. |
| Patient Satisfaction | 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively | It is a 5 choice questions asking for patient overall satisfaction to the operative shoulder, from very satisfied to very unsatisfied. |
| MRI Sugaya Classification | Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively | 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. |
| MRI Goutallier Classification | Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively | 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 |
| Return to Work/Activity | 6 weeks, 3-month, 6-month, 12-month 24-month post-operatively | The functional assessment of return to activity is evaluated by the time from discharge to return to work, driving, and sport. |
Countries
United States
Outcome results
None listed