Status:
TERMINATED
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
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 d...
Eligibility Criteria
Inclusion
- 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
- 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:
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
- Subjects with an occupational exposure to cobalt or chromium.
- Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
- Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
- Subjects who are undergoing a simultaneous bilateral total hip replacement.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00208364
Start Date
April 1 2004
End Date
September 1 2016
Last Update
October 7 2016
Active Locations (2)
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1
Ospedale Riuniti Di Bergamo
Bergamo, Italy
2
Royal Orthopaedic Hospital
Birmingham, United Kingdom