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

Primary Purpose

Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders

Status
Completed
Phase
Phase 4
Locations
New Zealand
Study Type
Interventional
Intervention
Marathon™
Enduron
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cemented

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Active Comparator

Arm Label

Marathon™

Enduron™

Arm Description

Moderately cross-linked polyethylene liner in a modular acetabular component

Standard UHMWPE polyethylene liner in a modular acetabular component

Outcomes

Primary Outcome Measures

Evaluate the linear and volumetric wear at the three-year time point.

Secondary Outcome Measures

Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively
Radiographic analysis
Oxford Hip Score
SF-12 for Mental and Physical well-being

Full Information

First Posted
September 13, 2005
Last Updated
June 23, 2017
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00208442
Brief Title
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
Official Title
A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2001 (Actual)
Primary Completion Date
September 1, 2006 (Actual)
Study Completion Date
September 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
Keywords
Hip, Cemented

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marathon™
Arm Type
Active Comparator
Arm Description
Moderately cross-linked polyethylene liner in a modular acetabular component
Arm Title
Enduron™
Arm Type
Active Comparator
Arm Description
Standard UHMWPE polyethylene liner in a modular acetabular component
Intervention Type
Device
Intervention Name(s)
Marathon™
Intervention Description
Moderately cross-linked polyethylene liner in a modular acetabular component
Intervention Type
Device
Intervention Name(s)
Enduron
Intervention Description
Standard polyethylene liner in a modular acetabular component
Primary Outcome Measure Information:
Title
Evaluate the linear and volumetric wear at the three-year time point.
Time Frame
10yrs post surgery
Secondary Outcome Measure Information:
Title
Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively
Time Frame
10yrs post surgery
Title
Radiographic analysis
Time Frame
10yrs post surgery
Title
Oxford Hip Score
Time Frame
10yrs post surgery
Title
SF-12 for Mental and Physical well-being
Time Frame
10yrs post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Otago, Wellington Medical School of Medicine
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18547784
Citation
Calvert GT, Devane PA, Fielden J, Adams K, Horne JG. A double-blind, prospective, randomized controlled trial comparing highly cross-linked and conventional polyethylene in primary total hip arthroplasty. J Arthroplasty. 2009 Jun;24(4):505-10. doi: 10.1016/j.arth.2008.02.011. Epub 2008 Jun 10.
Results Reference
result
PubMed Identifier
20458640
Citation
Mutimer J, Devane PA, Adams K, Horne JG. Highly crosslinked polyethylene reduces wear in total hip arthroplasty at 5 years. Clin Orthop Relat Res. 2010 Dec;468(12):3228-33. doi: 10.1007/s11999-010-1379-4.
Results Reference
result

Learn more about this trial

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

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