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Reverse Shoulder Prosthesis Study

NCT00764504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2011-04-19

Study results available
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Summary

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.

Conditions

  • Rotator Cuff Arthropathy
  • Failed Total Shoulder
  • Failed Hemi-arthroplasty

Interventions

DEVICE

Reverse Shoulder Prosthesis

For subjects with rotator cuff arthropathy and no previous shoulder device implanted.

DEVICE

Reverse Shoulder Prosthesis

For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.

Sponsors & Collaborators

  • Encore Medical, L.P.

    lead INDUSTRY

Principal Investigators

  • Mark Frankle, M.D. · Florida Orthopedic Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2008-06-30
Completion
2008-08-31

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 NCT00764504 on ClinicalTrials.gov