A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement

Sponsor

DePuy International (Industry)

Overall Status

Completed

CT.gov ID

NCT00208442

Collaborator

(none)

122

Enrollment

Location

Arms

147

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis	Device: Marathon™ Device: Enduron	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon

Actual Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Marathon™ Moderately cross-linked polyethylene liner in a modular acetabular component	Device: Marathon™ Moderately cross-linked polyethylene liner in a modular acetabular component
Active Comparator: Enduron™ Standard UHMWPE polyethylene liner in a modular acetabular component	Device: Enduron Standard polyethylene liner in a modular acetabular component

Arm

Intervention/Treatment

Active Comparator: Marathon™

Moderately cross-linked polyethylene liner in a modular acetabular component

Device: Marathon™

Moderately cross-linked polyethylene liner in a modular acetabular component

Active Comparator: Enduron™

Standard UHMWPE polyethylene liner in a modular acetabular component

Device: Enduron

Standard polyethylene liner in a modular acetabular component

Outcome Measures

Primary Outcome Measures

Evaluate the linear and volumetric wear at the three-year time point. [10yrs post surgery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects, aged between 45 and 75 years inclusive.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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.
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.
Subjects who have a Charnley C classification
Subjects who have undergone a contralateral hip replacement within past 6 months
Subjects with a poorly functioning contralateral hip replacement or one which has been identified as requiring revision
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:

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last month.