Status:
COMPLETED
Global® AP™ Total Shoulder Arthroplasty
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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
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 sa...
Eligibility Criteria
Inclusion
- Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00719771
Start Date
January 1 2008
End Date
October 1 2013
Last Update
May 22 2014
Active Locations (4)
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1
The CORE Institute
Phoenix, Arizona, United States, 85027
2
Mission Hospitals Research Institute
Asheville, North Carolina, United States, 28801
3
Wellington Orthopaedics and Sports Medicine
Cincinnati, Ohio, United States, 45230
4
Rosenberg Cooley Metcalf Clinic
Park City, Utah, United States, 84060