Trials / Completed
CompletedNCT00208442
A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement
A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- DePuy International · Industry
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Osteoarthritis
- Post-traumatic Arthritis
- Collagen Disorders
- Avascular Necrosis
- Traumatic Femoral Fractures
- Nonunion of Femoral Fractures
- Congenital Hip Dysplasia
- Slipped Capital Femoral Epiphysis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Marathon™ | Moderately cross-linked polyethylene liner in a modular acetabular component |
| DEVICE | Enduron | Standard polyethylene liner in a modular acetabular component |
Timeline
- Start date
- 2001-06-01
- Primary completion
- 2006-09-01
- Completion
- 2013-09-01
- First posted
- 2005-09-21
- Last updated
- 2017-06-26
Locations
1 site across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT00208442. Inclusion in this directory is not an endorsement.