A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Harris hip score
研究概览
简要总结
The investigators determined whether
- new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
- radiographically secure implant fixation is achieved with this new stem
- the bone content is preserved at the baseline level or above at the final follow-up
- these procedures are associated with early failure and complications.
详细描述
To attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a new short, metaphyseal-fitting cementless anatomical femoral stem was developed. The question arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal fixation in the young as well as in the elderly patients. The purpose of this study was to determine the clinical and radiographic results of the new short, metaphyseal-fitting cementless anatomical femoral stem in the young as well as in the elderly patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of hip joint requiring total hip arthroplasty
排除标准
- •Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient
- •Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
- •Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
研究组 & 干预措施
Younger Group
干预措施: Total Hip Arthroplasty (Device)
Elderly Group
干预措施: Total Hip Arthroplasty (Device)
结局指标
主要结局
Harris hip score
时间窗: At least 5 years after surgery
This is a verified scoring tool for measuring hip function.
次要结局
- Improvement in the Range of Motion(At least 5 years after surgery)
研究者
Young Hoo Kim
Professor
Ewha Womans University