A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Incidence of Clinically Significant Osteolysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Incidence of Clinically Significant Osteolysis
时间窗: 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.
次要结局
- 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)
研究者
C. Anderson Engh, Jr., MD
Investigator
Anderson Orthopaedic Research Institute