Global® AP™ Total Shoulder Arthroplasty

DePuy Synthes

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Global® AP™ Total shoulder arthroplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT00719771

05071

Details and patient eligibility

About

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

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.