Tapestry Rotator Cuff Repair PMCF

Status Not yet recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06287853
Study type	Observational
Source	Zimmer Biomet
Contact	Linda Anumele
Phone	2815058309
Email	carolyn.anumele@zimmerbiomet.com
Status	Not yet recruiting
Phase
Start date	June 30, 2024
Completion date	June 30, 2029

View Details

See also
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