Retrospective Encore Reverse Shoulder Prosthesis Study

Completed

• Conditions: Rotator Cuff Deficiency; Glenohumeral Arthritis

• Registration Number: NCT00765037
• Lead Sponsor: Encore Medical, L.P.

Brief Summary

The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2009-06-08
• Status Verified: 2010-08
• Results First Submitted QC: 2010-08-03
• Last Update Submitted: 2010-08-03
• Results First Posted: 2010-08-25
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
• The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Exclusion Criteria

• Infection or sepsis
• Insufficient bone quality which may affect the stability of the implant, as determined by the physician
• Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
• Alcoholism or other addictions
• Materials (metals, etc) sensitivity
• Loss of ligamentous structures
• High levels of physical activity
• Non-functional deltoid muscle

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survivorship of the Encore Reverse Shoulder Prosthesis	1 year	Number of subjects who completed all study visits through the 1 year visit.

Trial Locations

Locations (1)

Nashville Orthopedic Specialists; 🇺🇸 Nashville, Tennessee, United States