Global® AP™ Total Shoulder Arthroplasty

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

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

Key facts

Study ID

NCT00719771

Run by

DePuy Orthopaedics

People needed

64

Starts

2008-01-01

Expected to finish

2013-10-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• The CORE Institute — Phoenix, Arizona, United States
• Mission Hospitals Research Institute — Asheville, North Carolina, United States
• Wellington Orthopaedics and Sports Medicine — Cincinnati, Ohio, United States
• Rosenberg Cooley Metcalf Clinic — Park City, Utah, United States

Full record on ClinicalTrials.gov

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