Osteoarthritis
Conditions
Keywords
Osteoarthritis, Glenohumeral joint, Glenoid, Shoulder arthroplasty
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 satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.
Interventions
DEVICEGlobal® AP™ Total shoulder arthroplasty
Total shoulder arthroplasty
Sponsors
DePuy Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant Shoulder Score | Pre-op, 6, 12, 24 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed