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

Phase 4

Terminated

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

• Registration Number: NCT00208364
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2014-10
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 163

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 affect 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.

Additional Exclusion Criteria for Subjects Having Blood Analysis:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pinnacle Acetabular Cup System	Pinnacle Acetabular Cup System	A cementless acetabular cup with metal liner for use in total hip replacement

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship calculated at the 5 year time point.	5 years

Secondary Outcome Measures

Name	Time	Method
Harris 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
Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood	Annually
Oxford Hip score	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

Trial Locations

Locations (2)

Royal Orthopaedic Hospital; 🇬🇧 Birmingham, United Kingdom

Ospedale Riuniti Di Bergamo; 🇮🇹 Bergamo, Italy