NCT00719771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 22, 2014

Status Verified

December 1, 2013

Enrollment Period

5.8 years

First QC Date

July 21, 2008

Last Update Submit

May 20, 2014

Conditions

Osteoarthritis

Keywords

OsteoarthritisGlenohumeral jointGlenoidShoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Constant Shoulder Score

    Pre-op, 6, 12, 24 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

Global® AP™ Shoulder

OTHER

Global® AP™ Shoulder

Device: Global® AP™ Total shoulder arthroplasty

Interventions

Global® AP™ Total shoulder arthroplastyDEVICE

Total shoulder arthroplasty

Also known as: Global® AP™ Shoulder
Global® AP™ Shoulder

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The CORE Institute

Phoenix, Arizona, 85027, United States

Location

Mission Hospitals Research Institute

Asheville, North Carolina, 28801, United States

Location

Wellington Orthopaedics and Sports Medicine

Cincinnati, Ohio, 45230, United States

Location

Rosenberg Cooley Metcalf Clinic

Park City, Utah, 84060, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sam Himden, BA

    DePuy Orthopaedics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 22, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 22, 2014

Record last verified: 2013-12

Locations

US(4)