Retrospective Encore Reverse Shoulder Prosthesis Study

Encore Medical

Status: Completed

Conditions: Rotator Cuff Deficiency; Glenohumeral Arthritis

Treatments: Device: Encore Reverse Shoulder Prosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT00765037

PS - 902

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 1 patient group

Encore RSP

Description:

Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.

Treatment:

Device: Encore Reverse Shoulder Prosthesis