NCT03734536

Treatment of Partial-Thickness Rotator Cuff Tears

Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

Detailed description

The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (\>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

Conditions

• Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness

Interventions

Type	Name	Description
DEVICE	REGENETEN™ Bioinductive Implant	The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
DEVICE	Arthroscopic repair of the high-grade (>50%) partial-thickness	Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Timeline

• Start date: 2018-12-05
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2018-11-08
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study