Randomized Clinical Trial of a Cemented Versus Cementless Femoral Component for Metal on Metal Hip Resurfacing Assessing Bone Mineral Density
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Percent change in BMD (g/cm2)
研究概览
简要总结
The purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.
详细描述
Recent research is inconclusive regarding the degree to which the density or strength of the bone around the hip implant is preserved following a hip resurfacing system. Certainly, there are many factors which contribute to the preservation of bone mineral density - we are studying the role of cement. More specifically, we are trying to compare outcomes between patients who receive the cementless Cormet Hip Resurfacing System to those who receive the cemented CONSERVE® Plus Total Resurfacing Hip System. Therefore, the primary purpose of the current study is to compare the bone mineral density between the cementless and cemented hip resurfacing systems. We are also comparing patients who receive these two different hip systems in terms of their x-rays and how they are managing with their hip.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be undergoing primary hip surgery for Noninflammatory Degenerative Joint Disease
- •must be skeletally mature, as determined by Risser sign or reaching 18 years of age
- •Is reasonable expectation that patient will remain available for all FU's scheduled over course of 5 years
排除标准
- •Previous fusions, acute femoral neck fractures, and above knee amputations
- •evidence of active local infection
- •neurologic or musculoskeletal disease that may adversely affect gait or weight bearing
- •having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device
- •neuropathic joints
- •severe documented psychiatric disease
- •patients requiring structural bone grafts
- •documented allergy to cobalt chromium molybdenum
- •ipsilateral girdlestone
- •sickle cell disease
- •significant femoral head or neck deformity, or significant acetabular wall deficiency
- •patients with renal failure, defined as serum creatinine greater that 180 µmol/L
结局指标
主要结局
Percent change in BMD (g/cm2)
时间窗: 12 months
The primary outcome is percent change in BMD (g/cm2) from baseline to the 1-year post-operative interval, as measured radiographically in zone L1. Analysis of periprosthetic BMD will be achieved using 6 zones of the femoral neck, which have been used in previous studies
次要结局
- Implant Migration(24 months)
- WOMAC Questionnaire to assess functionality(24 months)
- RAND-36 Item Health Survey(24 months)
- Harris Hip Score (HHS) Questionnaire(24 months)
- UCLA Activity Score(24 months)