NCT04552119

Safety of Treatment of Shoulder Repair

Prospective, Multi-Center, Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 either rotator cuff repair and/or biceps tenodesis. 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.

Conditions

• Rotator Cuff

Interventions

Type	Name	Description
DEVICE	HEALICOIL Knotless PEEK	HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping
DEVICE	HEALICOIL Knotless REGENESORB	HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping

Timeline

• Start date: 2021-01-26
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2020-09-17
• Last updated: 2026-04-16
• Results posted: 2026-04-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study