A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and E… (NCT00208442) | Clinical Trial Compass
CompletedPhase 4
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
New Zealand122 participantsStarted 2001-06-01
Plain-language 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 requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be evaluated at regular intervals using clinical and x-ray assessments.
Who can participate
Age range45 Years – 75 Years
SexALL
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Inclusion Criteria:
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 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) 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) S…
What they're measuring
1
Evaluate the linear and volumetric wear at the three-year time point.