Global® AP™ Total Shoulder Arthroplasty

Sponsor

DePuy Orthopaedics (Industry)

Overall Status

Completed

CT.gov ID

NCT00719771

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

N/A

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 :

Jan 1, 2008

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Global® AP™ Shoulder

Global® AP™ Shoulder

Device: Global® AP™ Total shoulder arthroplasty

Total shoulder arthroplasty

Other Names:

Global® AP™ Shoulder

Outcome Measures

Primary Outcome Measures

Constant Shoulder Score [Pre-op, 6, 12, 24 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The CORE Institute	Phoenix	Arizona	United States	85027
2	Mission Hospitals Research Institute	Asheville	North Carolina	United States	28801
3	Wellington Orthopaedics and Sports Medicine	Cincinnati	Ohio	United States	45230
4	Rosenberg Cooley Metcalf Clinic	Park City	Utah	United States	84060