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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by DePuy International.
Recruitment status was:  Active, not recruiting
Information provided by:
DePuy International Identifier:
First received: September 13, 2005
Last updated: April 7, 2009
Last verified: April 2009
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Evaluate the linear and volumetric wear at the three-year time point. [ Time Frame: 3yrs post surgery ]

Secondary Outcome Measures:
  • Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively [ Time Frame: 3yrs post-surgery ]
  • Merle D'Aubigne [ Time Frame: 5yrs and 10 yrs post-surgery ]
  • Harris Hip score [ Time Frame: 5yrs and 10 yrs post-surgery ]
  • Radiographic analysis [ Time Frame: 5yrs and 10yrs post-surgery ]

Enrollment: 119
Study Start Date: June 2001
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 A classification.

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00208442

New Zealand
University Otago, Wellington Medical School of Medicine
Wellington, New Zealand
Sponsors and Collaborators
DePuy International
Study Director: Michael Borroff, B.Sc. M.Sc. DePuy International Ltd
  More Information

Responsible Party: Mick Borroff, DePuy International Ltd Identifier: NCT00208442     History of Changes
Other Study ID Numbers: CT99/31
Study First Received: September 13, 2005
Last Updated: April 7, 2009

Keywords provided by DePuy International:

Additional relevant MeSH terms:
Fractures, Bone
Hip Dislocation
Hip Dislocation, Congenital
Femoral Fractures
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Pathologic Processes
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Leg Injuries
Bone Diseases, Developmental
Bone Diseases
Epiphyses, Slipped
Connective Tissue Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators processed this record on June 22, 2017