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REGENETEN™ Bioinductive Implant System in Full-thickness Tears (REGENETEN Trial)

N/A
Waitlist Available
Led By Chris Peach, MBBS MD FRCS (Tr&Orth)
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months

Summary

This trial is testing a shoulder tendon repair surgery with an extra treatment called REGENETEN. It targets patients with large or massive shoulder tears. REGENETEN helps by providing a structure for new tissue to grow, aiding the healing process. REGENETEN is a bioinductive type-1 collagen implant used to repair partial-thickness rotator cuff tears without formal tendon-bone reattachment.

Eligible Conditions
  • Rotator Cuff Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6 months retear rate
Secondary study objectives
Constant-Murley Score
Cumulative duration of opioid use in ARCR augmented with REGENETEN versus ARCR alone
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
+14 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ARCR revision groupExperimental Treatment1 Intervention
ARCR revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Group II: ARCR augmented with REGENETEN™ Bioinductive ImplantExperimental Treatment1 Intervention
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Group III: ARCR alonePlacebo Group1 Intervention
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing

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Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor
169 Previous Clinical Trials
22,388 Total Patients Enrolled
Chris Peach, MBBS MD FRCS (Tr&Orth)Principal InvestigatorManchester University NHS Foundation Trust
~24 spots leftby Dec 2025
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