Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

DePuy Orthopaedics1 site in 1 country1,593 target enrollmentJuly 2000

ConditionsOsteoarthritis Rheumatoid Arthritis Arthritis Avascular Necrosis Acute Fracture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: DePuy Orthopaedics
Enrollment: 1593
Locations: 1
Primary Endpoint: Survivorship
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

Detailed Description

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Registry

clinicaltrials.gov

Start Date

July 2000

End Date

December 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

DePuy Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Primary hip replacement
•Sufficient bone stock to support implant
•Signed Informed Patient Consent form

Exclusion Criteria

•Prior renal transplant
•History of active joint sepsis
•Recent high dose of corticosteroids
•Primary or secondary carcinoma in the last 5 years
•Neurological disease
•Psychosocial disease that would limit rehabilitation
•Use of structural bone graft
•Simultaneous participation in another hip study

Outcomes

Primary Outcomes

Survivorship

Time Frame: 5 years

Secondary Outcomes

Harris Hip Score(Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.)
Short Form-36 (SF-36)(Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.)