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

Anderson Orthopaedic Research Institute

Status: Completed

Conditions: Osteoarthritis; Joint Diseases; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Treatments: Device: Total Hip Replacement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01121146

AORI2010-0100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

(from original study)

-None

(from 10-year follow-up)

• Patient did not receive device as specified in inclusion criteria.
• Patient refused to consent to the 10-year follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Crosslinked Marathon polyethylene

Active Comparator group

Treatment:

Device: Total Hip Replacement

Standard Enduron polyethylene

Active Comparator group

Treatment:

Device: Total Hip Replacement