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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00208442
Other study ID # CT99/31
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated June 23, 2017
Start date June 1, 2001
Est. completion date September 1, 2013

Study information

Verified date June 2017
Source DePuy International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date September 1, 2013
Est. primary completion date September 1, 2006
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Device:
Marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
Enduron
Standard polyethylene liner in a modular acetabular component

Locations

Country Name City State
New Zealand University Otago, Wellington Medical School of Medicine Wellington

Sponsors (1)

Lead Sponsor Collaborator
DePuy International

Country where clinical trial is conducted

New Zealand, 

References & Publications (2)

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: 10.101 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the linear and volumetric wear at the three-year time point. 10yrs post surgery
Secondary Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively 10yrs post surgery
Secondary Radiographic analysis 10yrs post surgery
Secondary Oxford Hip Score 10yrs post surgery
Secondary SF-12 for Mental and Physical well-being 10yrs post surgery
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