Retrospective Encore Reverse Shoulder Prosthesis Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rotator Cuff Deficiency Glenohumeral Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Encore RSP

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.

Encore Reverse Shoulder Prosthesis

Intervention Type DEVICE

rotator cuff deficiency and glenohumeral arthritis

Interventions

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Encore Reverse Shoulder Prosthesis

rotator cuff deficiency and glenohumeral arthritis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No