Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, nonunion of femoral fractures, congenital hip dysplasia, slipped capital femoral epiphysis
Treatment pinnacle acetabular cup system
Phase phase 4
Sponsor DePuy International
Start date April 2004
End date October 2014
Trial size 163 participants
Trial identifier NCT00208364, CT01/11

Summary

The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
A cementless acetabular cup with metal liner for use in total hip replacement
pinnacle acetabular cup system
A cementless acetabular cup with metal liner for use in total hip replacement

Primary Outcomes

Measure
Kaplan-Meier survivorship calculated at the 5 year time point.
time frame: 5 years

Secondary Outcomes

Measure
Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
time frame: Annually
Harris Hip score
time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Oxford Hip score
time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Radiological analysis
time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Metal ion analysis in whole blood
time frame: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: i) Male or female subjects, aged between 18 and 70 years inclusive. ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) Subjects undergoing revision hip replacement. iii) Women who are pregnant. iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. v) Subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) Subjects who are currently involved in any injury litigation claims. Additional Exclusion Criteria for Subjects Having Blood Analysis: 1. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy. 2. Subjects with an occupational exposure to cobalt or chromium. 3. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months. 4. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations. 5. Subjects who are undergoing a simultaneous bilateral total hip replacement.

Additional Information

Official title Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by DePuy International.