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ARCR augmented with REGENETEN™ Bioinductive Implant for Rotator Cuff Injury (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

Awards & highlights

REGENETEN Trial Summary

This trial is testing whether a new medical device called REGENETEN can help people who need surgery to repair a torn rotator cuff.

Eligible Conditions

Rotator Cuff Injury
Rotator Cuff Tears

REGENETEN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6 months retear rate

Secondary outcome measures

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

REGENETEN 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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor

165 Previous Clinical Trials

22,362 Total Patients Enrolled

Chris Peach, MBBS MD FRCS (Tr&Orth)Principal InvestigatorManchester University NHS Foundation Trust

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the scope of this clinical research?

"Currently, this trial requires participants from at least seven locations. These include Syracuse Orthopedic Specialists in DeWitt, McMaster University in Hamilton and Harbin Clinic in Rome among others."

Answered by AI

Are there still slots available for those interested in participating in this research?

"Clinicaltrials.gov reveals that this medical investigation is actively looking for participants, having first been posted on December 7th 2020 and most recently edited on September 30th 2022."

Answered by AI

How many participants have signed up to partake in this research study?

"The scope of this trial necessitates 300 eligible patients to partake. Potential participants from Syracuse Orthopedic Specialists in DeWitt, New york and McMaster University in Hamilton, Ontario are welcome to join."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

REGENETEN™ Bioinductive Implant System in Full-thickness Tears

2020. "REGENETEN™ Bioinductive Implant System in Full-thickness Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04450342.