Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron Vs. Marathon
This study is ongoing, but not recruiting participants.
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208442
  Purpose

The primary objective of this investigation is to evaluate the linear and volumetric wear of the two polyethylene materials.

The secondary objective of this investigation is to evaluate the 3D femoral head displacement and the clinical and radiological performance of the two polyethylene materials.


Condition Intervention Phase
Osteoarthritis, Hip
Device: Enduron polyethylene / Marathon polyethylene
Phase IV

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
  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

Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael Borroff, B.Sc. M.Sc. DePuy International Ltd
  More Information

Study ID Numbers: CT9931
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00208442  
Health Authority: New Zealand: Medicines and Medical Devices Safety Authority

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases
Osteoarthritis, Hip

ClinicalTrials.gov processed this record on January 16, 2009