Reverse Shoulder Prosthesis Prospective Multi-Center Study

NCT01005446 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 245

Last updated 2021-03-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).

Conditions

  • Rotator Cuff Deficiency
  • Shoulder Arthropathy
  • Failed Shoulder Replacement

Interventions

DEVICE

Encore Reverse Shoulder Prosthesis (RSP®)

The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

Sponsors & Collaborators

  • DJO Incorporated

    collaborator INDUSTRY
  • Encore Medical, L.P.

    lead INDUSTRY

Principal Investigators

  • Samer S. Hasan, M.D. · Cincinnati Sports Medicine and Orthopaedic Center

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2017-08-31
Completion
2018-06-30

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 NCT01005446 on ClinicalTrials.gov