A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cemented
Eligibility Criteria
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) Subjects who have participated in a clinical study with an investigational product in the last month.
Sites / Locations
- University Otago, Wellington Medical School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Marathon™
Enduron™
Moderately cross-linked polyethylene liner in a modular acetabular component
Standard UHMWPE polyethylene liner in a modular acetabular component