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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 because the information has not been verified recently.
Verified April 2009 by DePuy International.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00208442
First received: September 13, 2005
Last updated: April 7, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Merle D'Aubigne [ Time Frame: 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: Yes ]
  • Harris Hip score [ Time Frame: 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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 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
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
Investigators
Study Director: Michael Borroff, B.Sc. M.Sc. DePuy International Ltd
  More Information

Publications:

Responsible Party: Mick Borroff, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00208442     History of Changes
Other Study ID Numbers: CT99/31
Study First Received: September 13, 2005
Last Updated: April 7, 2009
Health Authority: New Zealand: Medicines and Medical Devices Safety Authority

Keywords provided by DePuy International:
Hip
Cemented

Additional relevant MeSH terms:
Arthritis
Collagen Diseases
Femoral Fractures
Fractures, Bone
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Wounds and Injuries
Leg Injuries
Musculoskeletal Abnormalities
 Congenital Abnormalities
Pathologic Processes
Bone Diseases
Rheumatic Diseases
Methyclothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013