Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

Not Applicable

Completed

• Conditions: Arthritis; Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Acute Fracture

• Registration Number: NCT00306930
• Lead Sponsor: DePuy Orthopaedics

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.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1593

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survivorship	5 years

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

DePuy Orthopaedics; 🇺🇸 Warsaw, Indiana, United States