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

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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.
We found this trial at
4
sites
Asheville, North Carolina 28801
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Asheville, NC
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Cincinnati, OH
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Park City, Utah 84060
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Park City, UT
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Sun City West, Arizona 85375
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Sun City West, AZ
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