A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement

Sponsor

DePuy International (Industry)

Overall Status

Terminated

CT.gov ID

NCT00208364

Collaborator

(none)

163

Enrollment

Locations

Arm

149

Duration (Months)

81.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis	Device: Pinnacle Acetabular Cup System	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

163 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Pinnacle Acetabular Cup System A cementless acetabular cup with metal liner for use in total hip replacement	Device: Pinnacle Acetabular Cup System A cementless acetabular cup with metal liner for use in total hip replacement

Arm

Intervention/Treatment

Other: Pinnacle Acetabular Cup System

A cementless acetabular cup with metal liner for use in total hip replacement

Device: Pinnacle Acetabular Cup System

A cementless acetabular cup with metal liner for use in total hip replacement

Outcome Measures

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the 5 year time point. [5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects, aged between 18 and 70 years inclusive.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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.
Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.

Exclusion Criteria:

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Subjects undergoing revision hip replacement.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 12 months.
Subjects who are currently involved in any injury litigation claims.

Additional Exclusion Criteria for Subjects Having Blood Analysis:

Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
Subjects with an occupational exposure to cobalt or chromium.
Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
Subjects who are undergoing a simultaneous bilateral total hip replacement.