Global® AP™ Total Shoulder Arthroplasty
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | January 2008 |
End Date: | December 2012 |
Contact: | Mary Panozzo, BS |
Email: | MPanozzo@its.jnj.com |
Phone: | 574-372-5939 |
A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
The purpose of this study is to observe the performance of the Global® AP™ shoulder implant.
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 brachioplexis 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.
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