Global® AP™ Total Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719771
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
DePuy Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Global® AP™ Total shoulder arthroplasty Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
Study Start Date : January 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Global® AP™ Shoulder
Global® AP™ Shoulder
Device: Global® AP™ Total shoulder arthroplasty
Total shoulder arthroplasty
Other Name: Global® AP™ Shoulder

Primary Outcome Measures :
  1. Constant Shoulder Score [ Time Frame: Pre-op, 6, 12, 24 months ]

Secondary Outcome Measures :
  1. SF-12 [ Time Frame: Pre-op, 6,12, 24 months ]
  2. Penn/ASES [ Time Frame: Pre-Op, 6, 12, and 24 months ]
  3. Radiographic Data [ Time Frame: Pre-Op, 6 weeks, 6, 12, and 24 months ]
  4. Quality of Life Survey [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719771

United States, Arizona
The CORE Institute
Phoenix, Arizona, United States, 85027
United States, North Carolina
Mission Hospitals Research Institute
Asheville, North Carolina, United States, 28801
United States, Ohio
Wellington Orthopaedics and Sports Medicine
Cincinnati, Ohio, United States, 45230
United States, Utah
Rosenberg Cooley Metcalf Clinic
Park City, Utah, United States, 84060
Sponsors and Collaborators
DePuy Orthopaedics
Study Director: Sam Himden, BA DePuy Orthopaedics

Responsible Party: DePuy Orthopaedics Identifier: NCT00719771     History of Changes
Other Study ID Numbers: 05071
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: December 2013

Keywords provided by DePuy Orthopaedics:
Glenohumeral joint
Shoulder arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases