Global® AP™ Total Shoulder Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00719771
First received: July 21, 2008
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention
Osteoarthritis
Device: Global® AP™ Total shoulder arthroplasty

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Constant Shoulder Score [ Time Frame: Pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-12 [ Time Frame: Pre-op, 6,12, 24 months ] [ Designated as safety issue: No ]
  • Penn/ASES [ Time Frame: Pre-Op, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Radiographic Data [ Time Frame: Pre-Op, 6 weeks, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Quality of Life Survey [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Global® AP™ Shoulder
Global® AP™ Shoulder
Device: Global® AP™ Total shoulder arthroplasty
Total shoulder arthroplasty
Other Name: Global® AP™ Shoulder

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719771

Locations
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
Investigators
Study Director: Sam Himden, BA DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00719771     History of Changes
Other Study ID Numbers: 05071
Study First Received: July 21, 2008
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
Osteoarthritis
Glenohumeral joint
Glenoid
Shoulder arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014