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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208442
First received: September 13, 2005
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
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: Triple (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: 10yrs post surgery ]

Secondary Outcome Measures:
  • Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively [ Time Frame: 10yrs post surgery ]
  • Radiographic analysis [ Time Frame: 10yrs post surgery ]
  • Oxford Hip Score [ Time Frame: 10yrs post surgery ]
  • SF-12 for Mental and Physical well-being [ Time Frame: 10yrs post surgery ]

Enrollment: 122
Actual Study Start Date: June 1, 2001
Study Completion Date: September 1, 2013
Primary Completion Date: September 1, 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

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.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208442

Locations
New Zealand
University Otago, Wellington Medical School of Medicine
Wellington, New Zealand
Sponsors and Collaborators
DePuy International
  More Information

Publications:
Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208442     History of Changes
Other Study ID Numbers: CT99/31
Study First Received: September 13, 2005
Last Updated: June 23, 2017

Keywords provided by DePuy International:
Hip
Cemented

Additional relevant MeSH terms:
Osteoarthritis
Fractures, Bone
Necrosis
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Pathologic Processes
Leg Injuries
Dislocations
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Epiphyses, Slipped
Connective Tissue Diseases
Methyclothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 21, 2017