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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Global® AP™ Total shoulder arthroplasty

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
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • The Core Institute
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospitals Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45230
      • Wellington Orthopaedics and Sports Medicine
  • Utah
    • Park City, Utah, United States, 84060
      • Rosenberg Cooley Metcalf Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Global® AP™ Shoulder	Device: Global® AP™ Total shoulder arthroplasty; Total shoulder arthroplasty; Other Names: Global® AP™ Shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Constant Shoulder Score	Pre-op, 6, 12, 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
SF-12	Pre-op, 6,12, 24 months
Penn/ASES	Pre-Op, 6, 12, and 24 months
Radiographic Data	Pre-Op, 6 weeks, 6, 12, and 24 months
Quality of Life Survey	6 weeks

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Sam Himden, BA, DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Osteoarthritis; Glenohumeral joint; Glenoid; Shoulder arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 05071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No