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Sponsored by: |
DePuy International |
---|---|
Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208442 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment |
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
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.
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 |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |