Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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

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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crosslinked Marathon polyethylene

Group Type ACTIVE_COMPARATOR

Total Hip Replacement

Intervention Type DEVICE

Comparison of Marathon and Enduron polyethylene

Standard Enduron polyethylene

Group Type ACTIVE_COMPARATOR

Total Hip Replacement

Intervention Type DEVICE

Comparison of Marathon and Enduron polyethylene

Interventions

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Total Hip Replacement

Comparison of Marathon and Enduron polyethylene

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

(from original study)

-Elective total hip replacement patient

(from 10-year follow-up)

* Consented to the original study.
* Received a Duraloc 100 cup with either a crosslinked Marathon or standard Enduron liner.
* Received an AML/Solution or a Prodigy stem with 28mm cobalt chrome femoral head.

* Patient refused to consent to the 10-year follow-up.