Global® AP™ Total Shoulder Arthroplasty | NCT00719771

Studies
Global® AP™ Total Shoulder Arthroplasty

NCT00719771

Sponsor

DePuy Orthopaedics

Status

Completed

Last Update Posted

May 22, 2014Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Global® AP™ Total shoulder arthroplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jul 21, 2008

First Submission Date that Met QC Criteria

Jul 21, 2008

First Posted Date

Jul 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2014

Last Update Posted Date

May 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Global® AP™ Shoulder	Other	Global® AP™ Shoulder	Device: Global® AP™ Total shoulder arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Global® AP™ Total shoulder arthroplasty	Device	Total shoulder arthroplasty	Global® AP™ Shoulder

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

Measure	Description	Time Frame
SF-12		Pre-op, 6,12, 24 months
Penn/ASES		Pre-Op, 6, 12, and 24 months
Radiographic Data

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The CORE Institute		Phoenix	Arizona	85027	United States
Mission Hospitals Research Institute

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases