Global® AP™ Total Shoulder Arthroplasty

A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty

This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.

The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.

Inclusion Criteria:

• Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.

Exclusion Criteria:

• Are under 18 years of age or over 70
• Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
• Have a hemi-arthroplasty
• Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
• Have arthritis with insufficient cuff tissue
• Have had a failed rotator cuff surgery
• Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
• Have evidence of active infection
• Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
• Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
• Are skeletally immature.
• Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
• Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
• Are currently participating in another clinical study
• Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
• Are currently involved in any personal injury litigation, medical legal or worker's compensation claims.