N/A Completed N=19

Retrospective Encore Reverse Shoulder Prosthesis Study

Rotator Cuff Deficiency · Glenohumeral Arthritis

Source: ClinicalTrials.gov NCT00765037 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcomePrimary: Survivorship of the Encore Reverse Shoulder Prosthesis — 13 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Survivorship of the Encore Reverse Shoulder Prosthesis	13	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00765037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.