NCT00175487Unknown不适用
Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation
研究概览
简要总结
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for hip resurfacing because of osteoarthritis or avascular necrosis
- •Aged 19 to 65 years old
- •Ability to give informed consent
排除标准
- •Previous fracture requiring internal fixation of the hip
- •Previous hip osteotomy (pelvic or femoral)
- •Dysplasia requiring structural bone graft
- •Inability to respond to questionnaires in English (or French, Montreal centre only)
- •The presence of osteopenia or osteoporosis
- •Evidence of hepatic/renal insufficiency or failure from medical history or laboratory assessment
结局指标
主要结局
To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation
时间窗: at 2 years
次要结局
- To estimate the difference in concentrations of cobalt and chromium ions in serum
- To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)(at 12 and 52 weeks)
- To estimate the lower limb functional instability by a test of postural balance
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/ExeterOsteoarthrosisNCT00116948University of Aarhus50
已完成
不适用
Influence of Femoral Head Size During Total Hip Arthroplasty on GaitOsteoarthritis, HipHip ArthritisGait, FrontalNCT04521842Medical University of Warsaw30
Unknown
不适用
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderlyFemoral Neck FracturesNCT02246335Danderyd Hospital120
Unknown
不适用
Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral StemTotal Hip ArthroplastyNCT01614028Rothman Institute Orthopaedics
已完成
不适用
Imaging of Joint Replacement Complications by PET/CTAdverse Reactions to Metal DebrisInfection of Total Hip Joint ProsthesisMechanical Loosening of Prosthetic JointNCT01970228Turku University Hospital12