A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Anderson Orthopaedic Research Institute
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Incidence of Clinically Significant Osteolysis
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
C. Anderson Engh, Jr., MD
Investigator
Anderson Orthopaedic Research Institute
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 the 10-year follow-up.
Outcomes
Primary Outcomes
Incidence of Clinically Significant Osteolysis
Time Frame: Minimum 9-year radiographic follow-up
The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis. Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph. To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software. Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.
Secondary Outcomes
- Polyethylene Wear(Minimum 9-year radiographic follow-up)
- Rate of Reoperation(10-year follow-up)
- Patient Satisfaction(Minimum 9-year follow-up)
- Harris Hip Score(Minimum 9-year follow-up)