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Post-Market Evaluation of the Rotation Medical Rotator Cuff System

NCT02200939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-03-02

Study results available
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Summary

The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.

Conditions

  • Partial Thickness Supraspinatus Tendon Tear
  • Full Thickness Supraspinatus Tendon Tear

Interventions

DEVICE

Bioinductive implant

DEVICE

Surgical repair

Surgical repair with commercially-available sutures/suture anchors.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Laura England · Smith & Nephew, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-20
Primary Completion
2020-11-24
Completion
2020-11-24
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 NCT02200939 on ClinicalTrials.gov