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NCT05444465 · ClinicalTrials.gov registry record · NA

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

A NA study of Rotator Cuff Injuries, sponsored by Smith & Nephew.

Recruiting
Registry status
NA
Development phase
234
Enrollment target
20
Study locations

NCT05444465 is a NA study of Rotator Cuff Injuries that is actively recruiting participants, run by Smith & Nephew. The registered enrollment target is 234 participants, above the 77-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT05444465, a NA study of Rotator Cuff Injuries, is actively recruiting participants, sponsored by Smith & Nephew.

RECRUITING
Registry status
NA
Development phase
234 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Interventions

  • DEVICE Isolated Bioinductive Repair
  • PROCEDURE Completion and Repair

Study Locations (20)

Other

  • IRCCS Istituto Ortopedico Galeazzi, - Milan
  • Fondazione Policlinico Universitario Campus Bio-Medico - Roma
  • Hospital Ramón y Cajal - Madrid
  • Hospital Fundación Jiménez Díaz - Madrid
  • Sulis Hospital - Bath
  • North Bristol NHS Trust - Bristol
  • Northern Care Alliance NHS Foundation Trust - Salford

Texas

  • Texas Orthopedic Specialists - Bedford
  • Houston Methodist The Woodlands - The Woodlands

Georgia

  • Harbin Clinic - Rome

Illinois

  • OrthoIllinois LTD - Rockford

Maryland

  • Sinai Hospital Baltimore - Baltimore

Ohio

  • Cleveland Clinic - Sports Health - Garfield Heights

Pennsylvania

  • University of Pittsburgh - Pittsburgh

Wisconsin

  • Memorial Medical Center - Ashland

Trial Details

FieldValue
Enrollment Target 234 participants
Start Date 2022-08-30
Est. Completion 2028-06-30
Phase NA

Sponsor

Smith & Nephew

72 total trials

What the Registry Record Tells You About NCT05444465

The ClinicalTrials.gov registry entry for NCT05444465 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 234 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 77-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (204% higher). The listed sponsor is Smith & Nephew, which has 72 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rotator Cuff Injuries appearing as the primary indexed condition, and to 2 interventions - of which Isolated Bioinductive Repair is the first listed.

NCT05444465 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Texas, Georgia.

Frequently Asked Questions

What is clinical trial NCT05444465 about?

NCT05444465 is a clinical study titled "Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears". 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.

What is the current status of trial NCT05444465?

This trial is currently recruiting. It is a NA study. The enrollment target is 234 participants. The study started on 2022-08-30. Estimated completion is 2028-06-30.

What conditions does trial NCT05444465 study?

This clinical trial studies the following conditions: Rotator Cuff Injuries.

What interventions are being tested in trial NCT05444465?

The interventions under investigation include: Isolated Bioinductive Repair (DEVICE), Completion and Repair (PROCEDURE).

Who is sponsoring clinical trial NCT05444465?

This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05444465 being conducted?

This trial has 20 study locations across Georgia, Illinois, Maryland, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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