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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00208442




Registration number
NCT00208442
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
26/06/2017

Titles & IDs
Public 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
Scientific title
A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon
Secondary ID [1] 0 0
CT99/31
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Post-traumatic Arthritis 0 0
Collagen Disorders 0 0
Avascular Necrosis 0 0
Traumatic Femoral Fractures 0 0
Nonunion of Femoral Fractures 0 0
Congenital Hip Dysplasia 0 0
Slipped Capital Femoral Epiphysis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Skin 0 0 0 0
Other skin conditions
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Marathon™
Treatment: Devices - Enduron

Active comparator: Marathon™ - Moderately cross-linked polyethylene liner in a modular acetabular component

Active comparator: Enduron™ - Standard UHMWPE polyethylene liner in a modular acetabular component


Treatment: Devices: Marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component

Treatment: Devices: Enduron
Standard polyethylene liner in a modular acetabular component
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the linear and volumetric wear at the three-year time point.
Timepoint [1] 0 0
10yrs post surgery
Secondary outcome [1] 0 0
Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively
Timepoint [1] 0 0
10yrs post surgery
Secondary outcome [2] 0 0
Radiographic analysis
Timepoint [2] 0 0
10yrs post surgery
Secondary outcome [3] 0 0
Oxford Hip Score
Timepoint [3] 0 0
10yrs post surgery
Secondary outcome [4] 0 0
SF-12 for Mental and Physical well-being
Timepoint [4] 0 0
10yrs post surgery

Eligibility
Key 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).
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00208442
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00208442