A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
NCT ID: NCT00208442
Last Updated: 2017-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2001-06-01
2013-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
Marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
Enduron™
Standard UHMWPE polyethylene liner in a modular acetabular component
Enduron
Standard polyethylene liner in a modular acetabular component
Interventions
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Marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
Enduron
Standard polyethylene liner in a modular acetabular component
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
75 Years
ALL
No
Sponsors
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DePuy International
INDUSTRY
Responsible Party
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Locations
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University Otago, Wellington Medical School of Medicine
Wellington, , New Zealand
Countries
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References
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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.
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.
Other Identifiers
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CT99/31
Identifier Type: -
Identifier Source: org_study_id
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