In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Orthopedics / Shoulder Replacement
Title
Evaluation of Encore Reverse Shoulder Prosthesis (Orthopedics / Shoulder Relacement)
Description
The purpose of this study is to evaluate the use and efficacy of the Reverse Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are having a total shoulder replacement.
IRB Number
Pro2099
Inclusion/Notes
INCLUSION:
Subjects must be a candidate for a total shoulder joint replacement.
Subject must be diagnosed with one or more of the following conditions:
Irreparable rotator cuff tear with gleno-humeral arthritis,
Failed rotator cuff surgery with gleno-humeral instbility or antero-superior escape,
Failed shoulder replacement surgery.
Subject must have a non-functional deltoid muscle.
Subject's joint must be antatomically and functionally suited to received the selected implant.
Subject is 60 years of age or older at the time of consent.
Subject is not pregnant.
EXCLUSION:
Subject has a functional deltoid muscle.
Subject has mental condition that may interfere with the subject's ability to give informed consent or willingness to fulfill the study requirements.
Subject is a prisoner.
Subject has high levels of physical activity.
Subject is pregnant.
Subject has an active infection or sepsis.
Subject has loss of ligamentous structures.
Subject has a history of alcoholism or other addictions (current or past).
Subject has muscular, neurological or vascular deficiences which compromise the affected extremity.
Subject has severe glenoid bone loss.
Subject has known materials sensitivity (to metals).
