A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

Sponsor

DePuy International (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00208429

Collaborator

(none)

Enrollment

Arm

180

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

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 :

0 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 System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

Actual Study Start Date :

Jul 1, 2004

Anticipated Primary Completion Date :

Jul 1, 2009

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Pinnacle Acetabular System	Device: Pinnacle Acetabular System

Arm

Intervention/Treatment

Other: Pinnacle Acetabular System

Device: Pinnacle Acetabular System

Outcome Measures

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the five-year time-point. [5 yrs post surgery]

Secondary Outcome Measures

Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score [6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery]
Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score [Annually up to 15 yrs post-surgery]
Kaplan-Meier survivorship [Annually up to 15 yrs 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 a cementless acetabular component and a metal on polyethylene bearing.

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.
Subjects undergoing simultaneous bilateral hip operation.
Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
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.