A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
NCT00208442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2017-06-26
Summary
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.
Conditions
- Osteoarthritis
- Post-traumatic Arthritis
- Collagen Disorders
- Avascular Necrosis
- Traumatic Femoral Fractures
- Nonunion of Femoral Fractures
- Congenital Hip Dysplasia
- Slipped Capital Femoral Epiphysis
Interventions
- DEVICE
-
Marathon™
Moderately cross-linked polyethylene liner in a modular acetabular component
- DEVICE
-
Enduron
Standard polyethylene liner in a modular acetabular component
Sponsors & Collaborators
-
DePuy International
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-06-01
- Primary Completion
- 2006-09-01
- Completion
- 2013-09-01
Countries
- New Zealand
Study Locations
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