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

Sponsor

DePuy International (Industry)

Overall Status

Terminated

CT.gov ID

NCT00872222

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a ceramic-on-ceramic 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.

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 System	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

98 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 Ceramic-on-ceramic Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Ceramic-on-Ceramic Pinnacle™ Acetabular System with ceramic liner	Device: Pinnacle™ Acetabular System A cementless acetabular cup with ceramic liner for use in total hip replacement

Arm

Intervention/Treatment

Other: Ceramic-on-Ceramic

Pinnacle™ Acetabular System with ceramic liner

Device: Pinnacle™ Acetabular System

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

Outcome Measures

Primary Outcome Measures

Kaplan-Meier survivorship at the five-year period [5yrs]

Secondary Outcome Measures

Kaplan-Meier survivorship calculations [Annually]
Harris Hip Score [6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery]
Radiographic analysis [6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery]
Oxford Hip score [3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs 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 effect 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.
Subjects undergoing a simultaneous bilateral hip operation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily