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Treatment of Partial-Thickness Rotator Cuff Tears

NCT03734536 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-11-19

Study results available
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Summary

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

Conditions

  • Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness

Interventions

DEVICE

REGENETEN™ Bioinductive Implant

The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.

DEVICE

Arthroscopic repair of the high-grade (>50%) partial-thickness

Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Sponsors & Collaborators

  • Global Research Solutions

    collaborator INDUSTRY

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Harris · Texas Orthopedic Specialists

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2023-09-11
Completion
2023-09-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734536 on ClinicalTrials.gov