Global® AP™ Total Shoulder Arthroplasty

NCT ID: NCT00719771

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Global® AP™ Shoulder

Global® AP™ Shoulder

Group Type: OTHER

Global® AP™ Total shoulder arthroplasty

Intervention Type: DEVICE

Total shoulder arthroplasty

Interventions

Global® AP™ Total shoulder arthroplasty

Total shoulder arthroplasty

Intervention Type: DEVICE

Other Intervention Names

Global® AP™ Shoulder

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Himden, BA

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

The CORE Institute

Phoenix, Arizona, United States

Mission Hospitals Research Institute

Asheville, North Carolina, United States

Wellington Orthopaedics and Sports Medicine

Cincinnati, Ohio, United States

Rosenberg Cooley Metcalf Clinic

Park City, Utah, United States

Countries

United States

Other Identifiers

05071

Identifier Type: -

Identifier Source: org_study_id