RecruitingNot ApplicableNCT05444465

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

Sponsor

Smith & Nephew, Inc.

Enrollment

234 participants

Start Date

Aug 30, 2022

Study Type

INTERVENTIONAL

Conditions

rotator cuff injuries

Summary

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Completion and Repair and a medical device called Isolated Bioinductive Repair for people with rotator cuff injuries. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIsolated Bioinductive Repair

Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

PROCEDURECompletion and Repair

Standard surgical repair using the 'Completion and Repair' technique.

Locations(20)

Harbin Clinic

Rome, Georgia, United States

OrthoIllinois LTD

Rockford, Illinois, United States

Sinai Hospital Baltimore

Baltimore, Maryland, United States

Cleveland Clinic - Sports Health

Garfield Heights, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Texas Orthopedic Specialists

Bedford, Texas, United States

Houston Methodist The Woodlands

The Woodlands, Texas, United States

Memorial Medical Center

Ashland, Wisconsin, United States

OrthoSport Victoria

Richmond, Victoria, Australia

Access Orthopaedics

Calgary, Alberta, Canada

Pan Am Clinic

Winnipeg, Manitoba, Canada

Research St. Joseph's

Hamilton, Ontario, Canada

IRCCS Istituto Ortopedico Galeazzi,

Milan, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy

Hospital Ramón y Cajal

Madrid, Spain

Hospital Fundación Jiménez Díaz

Madrid, Spain

Ashford & St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, United Kingdom

Sulis Hospital

Bath, United Kingdom

North Bristol NHS Trust

Bristol, United Kingdom

Northern Care Alliance NHS Foundation Trust

Salford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05444465

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