Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:
研究概览
简要总结
This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis
详细描述
Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.
Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.
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
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary osteoarthritis of the hip scheduled for THA.
- •Suitable anatomy for both stems
- •Willingness and ability to follow study-protocol
排除标准
- •Malignancy or metastatic bone disease.
- •Any other disease severely affecting bone and mineral metabolism
- •Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
- •Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
- •Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
- •Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
- •Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.
结局指标
主要结局
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:
时间窗: bone mineral density (BMD) measured postoperatively at 2 years
次要结局
- Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis(2 years)
研究者
Ingemar Ivarsson
Associate Professor
University Hospital, Linkoeping