Retrospective Encore Reverse Shoulder Prosthesis Study

Completed

• Conditions: Rotator Cuff Deficiency; Glenohumeral Arthritis
• Interventions: Device: Encore Reverse Shoulder Prosthesis

• 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

Arm && Interventions

Group	Intervention	Description
Encore RSP	Encore Reverse Shoulder Prosthesis	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.

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