A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty at Long-Term Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Anderson Orthopaedic Research Institute
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Percentage of Hips Surviving at 15 Years
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in survivorship due to wear-related revisions at minimum 14-year follow-up and every 5 years after.
Detailed Description
Several institutions have reported very low wear rates with crosslinked polyethylene based on early and midterm clinical data. However, since revisions associated with osteolysis typically occur after 10-year follow-up, the greatest benefits of the reduced wear associated with crosslinked polyethylene are expected to be reflected in lower revision rates for wear-related complications at long-term follow-up. While crosslinking has proven to substantially reduce polyethylene wear during the first decade in vivo, characterizing the long-term clinical performance of Marathon polyethylene remains important because crosslinking is accompanied by a reduction in the ultimate tensile strength, fatigue strength, and elongation to failure of ultra high molecular weight polyethylene. As a consequence, concerns have been expressed about the potential for the liner fracture, in vivo polyethylene oxidation or accelerated wear at long-term follow-up, the effects of femoral head roughening over time and the bioreactivity of crosslinked polyethylene debris particles. Ultimately, the best way to address these concerns is in the context of well-controlled, long-term clinical outcome studies. This study will evaluate outcome at a minimum of 14-years after surgery among the same group of patients whose outcome was previously reported at 10-year follow-up. As part of our efforts to follow patients throughout their lives to obtain long-term outcome data, we will continue to obtain routine follow-up every 5 years from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years). Because we anticipate that the reduced incidence of wear and osteolysis will result in a lower incidence of revision surgery among the patients randomized to Marathon liners, implant revision for reasons related to wear will be our primary outcome measure at long-term follow-up.
Investigators
Eligibility Criteria
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)
- •(from 10-year follow-up)
- •Patient did not receive device as specified in inclusion criteria.
- •Patient refused to consent to continued follow-up.
Outcomes
Primary Outcomes
Percentage of Hips Surviving at 15 Years
Time Frame: At 15-year follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years)
Kaplan-Meier survivorship was calculated using revision for wear/osteolysis as an endpoint.
Secondary Outcomes
- Polyethylene Wear(At minimum 14-year radiographic follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years))
- Incidence of Clinically Important Osteolysis Among Unrevised THAs(At minimum 14-year radiographic follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years))
- Harris Hip Score(At minimum 14-year follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years))
- Patients Who Answered "Yes" to the Question, "Are You Satisfied With the Results of Your Hip Operation?"(At minimum 14-year follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years))