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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: Recruiting NA study of Rotator Cuff Injuries, sponsored by Smith & Nephew.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an
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
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2022-08-30 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
What NCT05444465 shows while recruiting
NCT05444465 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (204% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Rotator Cuff Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05444465's enrollment target sits among peer trials
234 1st of 10 higher than 10 of 10 other Rotator Cuff Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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