Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects

Encore Medical, L.P.1 site in 1 country19 target enrollmentAugust 2008

ConditionsRotator Cuff Deficiency Glenohumeral Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff Deficiency
Sponsor: Encore Medical, L.P.
Enrollment: 19
Locations: 1
Primary Endpoint: Survivorship of the Encore Reverse Shoulder Prosthesis
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

May 2009

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Encore Medical, L.P.

Eligibility Criteria

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