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Global® AP™ Total Shoulder Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719771
First Posted: July 22, 2008
Last Update Posted: May 22, 2014
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.
Information provided by (Responsible Party):
DePuy Orthopaedics
July 21, 2008
July 22, 2008
May 22, 2014
January 2008
October 2013   (Final data collection date for primary outcome measure)
Constant Shoulder Score [ Time Frame: Pre-op, 6, 12, 24 months ]
Constant Score [ Time Frame: Pre-op, 6, 12, 24 months ]
Complete list of historical versions of study NCT00719771 on ClinicalTrials.gov Archive Site
  • SF-12 [ Time Frame: Pre-op, 6,12, 24 months ]
  • Penn/ASES [ Time Frame: Pre-Op, 6, 12, and 24 months ]
  • Radiographic Data [ Time Frame: Pre-Op, 6 weeks, 6, 12, and 24 months ]
  • Quality of Life Survey [ Time Frame: 6 weeks ]
SF-12, Penn/ASES, Radiographic Evaluation [ Time Frame: Pre-op, 6-weeks (subjective QOL and radiographic only), 6,12, 24 months ]
Not Provided
Not Provided
 
Global® AP™ Total Shoulder Arthroplasty
A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoarthritis
Device: Global® AP™ Total shoulder arthroplasty
Total shoulder arthroplasty
Other Name: Global® AP™ Shoulder
Global® AP™ Shoulder
Global® AP™ Shoulder
Intervention: Device: Global® AP™ Total shoulder arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
October 2013
October 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00719771
05071
No
Not Provided
Not Provided
DePuy Orthopaedics
DePuy Orthopaedics
Not Provided
Study Director: Sam Himden, BA DePuy Orthopaedics
DePuy Orthopaedics
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP