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Clinical Trial Summary

This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair

Clinical Trial Description

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with rotator cuff tendon repair. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04552119
Study type Observational
Source Smith & Nephew, Inc.
Status Active, not recruiting
Start date December 30, 2020
Completion date December 31, 2024

See also
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