Avascular Necrosis, Collagen Disorders, Congenital Hip Dysplasia, Nonunion of Femoral Fractures, Osteoarthritis, Post-traumatic Arthritis, Slipped Capital Femoral Epiphysis, Traumatic Femoral Fractures
Conditions
Keywords
Hip, Cemented
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 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.
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 and 10 years post-operative. Merle D'Aubigne score evaluation was removed per Amendment 2. However, protocol-specified data collected included only the linear and volumetric wear and incidence and pattern of radiological signs at 10 years post surgery. Data collected outside of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10 years post surgery and revision for any reason.
Interventions
DEVICEMarathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
DEVICEEnduron
Standard polyethylene liner in a modular acetabular component
Sponsors
DePuy International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the linear and volumetric wear at the three-year time point. | 10yrs post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively | 10yrs post surgery |
| Radiographic analysis | 10yrs post surgery |
| Oxford Hip Score | 10yrs post surgery |
| SF-12 for Mental and Physical well-being | 10yrs post surgery |
Countries
New Zealand
Outcome results
None listed