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Outcomes in Rotator Cuff Repair Using Graft Reinforcement

NCT01025037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-01-26

Study results available
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Summary

The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.

Conditions

  • Rotator Cuff Tear

Interventions

DEVICE

Conexa Reconstructive Tissue Matrix

Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures

Sponsors & Collaborators

  • LifeCell

    collaborator INDUSTRY

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Joseph Iannotti, MD · Cleveland, OH

  • John Sperling, MD · Rochester, MN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-02-28
Completion
2014-04-30

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 NCT01025037 on ClinicalTrials.gov