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

Phase 4

Withdrawn

• Conditions: Osteoarthritis; Collagen Disorders; Nonunion of Femoral Fractures; Rheumatoid Arthritis; Traumatic Femoral Fractures; Slipped Capital Femoral Epiphysis; Post-traumatic Arthritis; Avascular Necrosis; Congenital Hip Dysplasia
• Interventions: Device: Pinnacle Acetabular System

• Registration Number: NCT00208429
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-07-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 a cementless acetabular component and a metal on polyethylene bearing.

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) Subjects undergoing simultaneous bilateral hip operation.

iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

viii) Subjects who are currently involved in any injury litigation claims.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pinnacle Acetabular System	Pinnacle Acetabular System	-

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship calculated at the five-year time-point.	5 yrs post surgery

Secondary Outcome Measures

Name	Time	Method
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
Kaplan-Meier survivorship	Annually up to 15 yrs post-surgery
Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score	Annually up to 15 yrs post-surgery