A multi-center, prospective post-market clinical follow-up study: subscapularis repair augmented with Tapestry Biointegrative Implant after shoulder arthroplasty. The primary objective of this study is to evaluate the long-term integrity of the subscapularis tendon repair after shoulder arthroplasty augmented with Tapestry Biointegrative Implant, assessed by ultrasound 6 months postoperatively. Secondary objectives are to assess shoulder function (internal rotation strength), safety, and patient reported outcomes. Patients will be evaluated preoperatively, at the time of surgery, 3, 6, 12 and 24 months after surgery.
The proposed investigation is a multi-center, prospective patient registry: subscapularis repair augmented with TAPESTRY® Biointegrative Implant after shoulder arthroplasty. The primary objective of this study is to evaluate the long-term integrity of the subscapularis tendon repair after shoulder arthroplasty augmented with TAPESTRY Biointegrative Implant, assessed by ultrasound 6 months postoperatively. Secondary objectives are to assess shoulder function (internal rotation strength), safety, and patient reported outcomes. Patients will be evaluated preoperatively, at the time of surgery, 3, 6, 12 and 24 months after surgery. A total of 100 patients will be enrolled. Enrolled subjects will include adults undergoing shoulder arthroplasty, who meet the study eligibility criteria. The Tapestry Biointegrative Implant was FDA 510(k) cleared (K201572) on October 22, 2020, for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The primary analysis of subscapularis tendon repair integrity assessed by ultrasound will occur when all study subjects reach 6 months post-surgery. The goal of the analysis is to show that the tendon failure rate for subscapularis repair with Tapestry is lower than the failure rate for subscapularis repair without Tapestry a receiving surgery with the Tapestry and the literature-defined failure rate for tendon healing. Secondary endpoints will be analyzed when the last subject reaches the 24 month timepoint.
Study Type
OBSERVATIONAL
Enrollment
100
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. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant.
Alta Orthopaedics
Santa Barbara, California, United States
HCA Florida - JFK Hospital
Atlantis, Florida, United States
Atlantis Orthopaedics
Palm Beach Gardens, Florida, United States
Central Indiana Orthopedics
Carmel, Indiana, United States
Subscapularis repair integrity
Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.
Time frame: 6 months postoperatively
Subscapularis tendon tissue quality
Assessed using ultrasound to evaluate and measure thickness compared to normal (9, 10) subscapularis tendon thickness at 6-months postoperatively. Tendon tissue thickness and quality evaluation will be measured by trained personnel per the EMBODY-003 ultrasound procedure manual.
Time frame: 6 months postoperatively
Internal rotation strength in the belly-press (11,12) position, measured by an electronic handheld dynamometer.
Subscapularis repair integrity
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Subscapularis repair integrity
Assessed by internal rotation strength in the Bear-Hug position.
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Adverse events
Procedure and/or treatment
Time frame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Serious adverse events
Procedure and/or treatment
Time frame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Serious adverse events necessitating a second surgical intervention (SSI)
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University of Louisville Physicians, Inc.
Louisville, Kentucky, United States
Procedure and/or treatment
Time frame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient Questionnaire
Patient Satisfaction
Time frame: 3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Forward evaluation
Active Range of Motion (ROM)
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Abduction
Active ROM
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
External rotation
Active ROM
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Internal rotation
Active ROM
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
American Shoulder and Elbow Surgeon Evaluation (ASES)
Patient reported clinical outcome scores
Time frame: Baseline/3 months/6 months/12 months/24 months postoperatively
Visual Analog Scale (VAS)
Patient reported clinical outcome scores
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Simple Shoulder Test (SST)
Patient reported clinical outcome scores
Time frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively