Retrospective Encore Reverse Shoulder Prosthesis Study

Completed

Conditions studied: Rotator Cuff Deficiency, Glenohumeral Arthritis

In brief

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.

Key facts

Study ID

NCT00765037

Run by

Encore Medical, L.P.

People needed

19

Starts

2008-08-01

Expected to finish

2009-05-01

Last updated by the study team

2010-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Nashville Orthopedic Specialists — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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