Arthrex Eclipse™ Shoulder Prosthesis

Exclusion Criteria

• •The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: Avascular Necrosis of the humeral head without glenoid involvement (Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone deficiency/deformity that precludes glenoid replacement (Walch Type B2 or C) or Fractures of the Proximal Humerus, without Glenoid involvement.
• •The subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone.
• •The subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation.
• •The subject has a target shoulder a rotator cuff that is not intact and not reconstructible.
• •The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder.
• •The subject has documented history of foreign-body sensitivity.
• •Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period
• •The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV.
• •The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses.
• •The subject is at high risk for poor healing or confounding outcomes \[(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)\]
• •The subject is on immune-stimulating or immunosuppressive agents
• •The subject has co-morbidity that reduces life expectancy \< 36 month.
• •The subject seeking or receiving workman's compensation for shoulder injury,
• •The subject is \> 350 lbs.
• •The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.)
• •The subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures)
• •The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports)
• •The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers)
• •The subject is a prisoners or wards of the state
• •The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine)
• •The subject has an active or chronic infection, either systemic or local.
• •The subject has pathologic fractures of the affected shoulder
• •The subject has acute trauma of the affected shoulder
• •The subject has osteoporosis defined as a bone density T score of \< or = -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) and MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients who require a DEXA (dual energy x-ray absorptiometry) bone mineral density measurement.