Global® AP™ Total Shoulder Arthroplasty

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

Detailed Description
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Global® AP™ Total shoulder arthroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Global® AP™ Shoulder<br>Global® AP™ Shoulder | Device: Global® AP™ Total shoulder arthroplasty<br>* Total shoulder arthroplasty<br>* Other names: Global® AP™ Shoulder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Shoulder Score |  | Pre-op, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 |  | Pre-op, 6,12, 24 months | 
| Penn/ASES |  | Pre-Op, 6, 12, and 24 months | 
| Radiographic Data |  | Pre-Op, 6 weeks, 6, 12, and 24 months | 
| Quality of Life Survey |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Glenohumeral joint, Glenoid, Shoulder arthroplasty