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

Phase 4

Terminated

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

• Registration Number: NCT00872222
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

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 effect 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.

vii) Subjects undergoing a simultaneous bilateral hip operation.

viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.

ix) 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ceramic-on-Ceramic	Pinnacle™ Acetabular System	Pinnacle™ Acetabular System with ceramic liner

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship at the five-year period	5yrs

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship calculations	Annually
Radiographic analysis	6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Harris Hip Score	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

Trial Locations

Locations (1)

St Anne's University Hospital; 🇨🇿 Brno, Czech Republic