Overview

This trial is active, not recruiting.

Conditions osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, nonunion of femoral fractures, congenital hip dysplasia, slipped capital femoral epiphysis
Treatments marathon™, enduron
Phase phase 4
Sponsor DePuy International
Start date June 2001
End date September 2006
Trial size 119 participants
Trial identifier NCT00208442, CT99/31

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Moderately cross-linked polyethylene liner in a modular acetabular component
marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
(Active Comparator)
Standard UHMWPE polyethylene liner in a modular acetabular component
enduron
Standard polyethylene liner in a modular acetabular component

Primary Outcomes

Measure
Evaluate the linear and volumetric wear at the three-year time point.
time frame: 3yrs post surgery

Secondary Outcomes

Measure
Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively
time frame: 3yrs post-surgery
Merle D'Aubigne
time frame: 5yrs and 10 yrs post-surgery
Harris Hip score
time frame: 5yrs and 10 yrs post-surgery
Radiographic analysis
time frame: 5yrs and 10yrs post-surgery

Eligibility Criteria

Male or female participants from 45 years up to 75 years old.

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 A classification. 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.

Additional Information

Official title A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by DePuy International.