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.
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
170
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.
Premier Ortho & Trauma Specialists
Pomona, California, United States
UofL Health
Louisville, Kentucky, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Re-tear rate after arthroscopic rotator cuff repair
Assessed by MRI evaluation at 6 months post-operatively defined using Sugaya classification system.
Time frame: 6-month Post-operatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively