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临床试验/NCT00658268
NCT00658268已完成2 期

Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.

Region Skane1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年3月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
Region Skane
入组人数
32
试验地点
1
主要终点
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)

研究概览

简要总结

The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.

详细描述

Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety.

We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.

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
Double (Participant, Investigator)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique
  • Obtained informed consent
  • Pregnancy excluded in women of childbearing age

排除标准

  • Patients with known renal disease or S-creatinine >175 mcmol/L
  • Patients with S-calcium 2.75 mmol/L
  • Patients with diagnosed Rheumatoid arthritis
  • Patients with active primary hyperparathyroidism

研究组 & 干预措施

1

Experimental

干预措施: Clodronate (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)

时间窗: 12 months

次要结局

  • Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)(12-24 months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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