Trials / Completed
CompletedNCT01121146
Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- Anderson Orthopaedic Research Institute · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in bone loss around the hip implant.
Detailed description
Several institutions report very low wear rates with highly crosslinked polyethylene based on early clinical data. However, since bone loss typically appears after 5-year follow-up, the reduction in the incidence and extent of bone loss among total hip replacement patients with crosslinked Marathon liners, compared to those with standard Enduron liners, has not been as dramatic as the wear reduction. Despite the substantial reduction in wear that we observed at 5-year follow-up, the patients' perceptions of their outcomes remained similar among the Marathon and Enduron groups. This study will evaluate outcome at a minimum of 10-years after surgery among the same group of patients whose outcome was previously reported at 5-year follow-up. At 10-year follow-up, we anticipate that the reduction in wear associated with Marathon polyethylene will be associated with significant reductions in bone loss when compared to the Enduron polyethylene.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Hip Replacement | Comparison of Marathon and Enduron polyethylene |
Timeline
- Start date
- 1998-12-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2010-05-12
- Last updated
- 2014-11-05
- Results posted
- 2014-11-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01121146. Inclusion in this directory is not an endorsement.