Status:
COMPLETED
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Post-traumatic Arthritis
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the performance and compare the wear characteristics of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip joint disease...
Detailed Description
The original protocol intended to perform clinical assessment using the Harris Hip Score, Merle D'Aubigne score and UCLA Activity Level Rating at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years a...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged between 45 and 75 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 with non-inflammatory arthritis of the hip who require a primary hip arthroplasty and are considered by the Clinical Investigator to be suitable for a cemented femoral component and an uncemented acetabular component.
- v) Subjects who have a Charnley C classification
- vi) Subjects who have undergone a contralateral hip replacement within past 6 months
- vii) Subjects with a poorly functioning contralateral hip replacement or one which has been identified as requiring revision
- viii) The first hip replacement scheduled for subjects identified as requiring primary bi-lateral hip replacements which will not be conducted simultaneously (i.e. on the same day).
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) Women who are pregnant.
- iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- iv) Subjects who have participated in a clinical study with an investigational product in the last month.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00208442
Start Date
June 1 2001
End Date
September 1 2013
Last Update
June 26 2017
Active Locations (1)
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1
University Otago, Wellington Medical School of Medicine
Wellington, New Zealand