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临床试验/NCT03692351
NCT03692351已完成不适用

Osteolysis Development Over Time Around Uncemented Titanium Fiber Mesh Cups With or Without Screw Holes

Sahlgrenska University Hospital0 个研究点目标入组 95 人开始时间: 1994年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
主要终点
Periacetabular osteolysis size change between 7 and 18 years

研究概览

简要总结

In order to investigate the role of acetabular cup screw holes for the transport of osteolysis-inducing particles in a total hip arthroplasty articulation, the investigators compare the amount of bone loss around acetabular cups with and without holes. Bone loss is measured with computed tomography at 7 years and 15 - 18 years of follow-up.

详细描述

Particles generated by wear and corrosion within an artificial hip articulation can cause biologically mediated bone loss in the surrounding pelvis. Particles can be found within immunologically active cells inside bone lesions. Holes intended for screw fixation in uncemented acetabular cups are believed to be a main route for these particles from the articulation into the pelvic bone. Using pressfit, screws are not always necessary for a successful fixation of an uncemented cup. The investigator's hypothesis is that a pressfit fixated cup without screw holes will display a decreased amount of periacetabular osteolysis compared to a cup with screw holes. Therefore, 95 hips (90 patients) were randomized to receive either pressfit cups without screw holes or the same type of cup with screw holes. The occurence and size of periacetabular osteolysis will be compared between the two groups. In addition, since the patients will have a computed tomography examination at 7 years and between 15 and 18 years the investigator will also analyze development of periacetabular osteolysis over time. The different cups were paired with three different types of femoral stems. Also, articulation wear and cup and stem fixation will be analyzed using radiostereometry.

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
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary or secondary osteoarthritis

排除标准

  • Inflammatory osteoarthritis, hip joint infection

结局指标

主要结局

Periacetabular osteolysis size change between 7 and 18 years

时间窗: Change between 7 to 18 years after surgery

Size of periacetabular osteolysis (cm3) masured with computed tomography

Periacetabular osteolysis frequency change between 7 and 18 years

时间窗: Change between 7 to 18 years after surgery

Frequency of osteolysis (%) measured with computed tomography

次要结局

  • Cup fixation (translation)(18 years postoperatively)
  • Cup fixation (rotation)(18 years postoperatively)
  • Polyethylene wear(18 years postoperatively)

研究者

发起方
Sahlgrenska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per-Erik Johanson

Researcher

Sahlgrenska University Hospital

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