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临床试验/NCT02579174
NCT02579174已完成不适用

Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation

Northwestern University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Post-Operative Hip-Knee-Angle (HKA)

研究概览

简要总结

  1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT)
  2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants.
  3. To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT

详细描述

Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during Total Knee Replacement (TKR) is of great importance as it contributes to better function, less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. Malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening.

Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. Customized instrumentation created from a preoperative CT has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. However, taking into consideration CT's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be used routinely as a postoperative tool to evaluate TKR implant positioning.

The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for CT and ten times less than the plain radiography) by using a gaseous detector. George Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS system can provide 3D images by using the appropriate software algorithms, thus providing a low-radiation alternative to CT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Radiographically confirmed diagnosis of osteoarthritis (OA)
  • •Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
  • •Age greater than 18 years
  • •Desire to proceed with elective TKR
  • •Completion of informed consent and signature of written consent form

排除标准

  • •Ligamentous instability that may necessitate a constrained TKR implant
  • •Retained hardware in the distal femur or proximal tibia of the operative extremity
  • •Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT

研究组 & 干预措施

Custom (tibia) and manual (femur)

Other

Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component

干预措施: Medacta GMK Sphere (Device)

Manual (tibia) and manual (femur)

Other

Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component

干预措施: Medacta GMK Sphere (Device)

Manual (tibia) and custom (femur)

Other

Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component

干预措施: Medacta GMK Sphere (Device)

Custom (tibia) and custom (femur)

Other

Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component

干预措施: Medacta GMK Sphere (Device)

结局指标

主要结局

Post-Operative Hip-Knee-Angle (HKA)

时间窗: Pre-operative, 6 wks. post-op

Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation

次要结局

  • Tibial Posterior Slope (Mean Deviation)(Pre-Operative - 6 wk. Post-Operative)
  • Tibial Varus Deformity(Pre-operative, 6 wks. post-op)
  • Femoral Valgus Deformity(Pre-operative, 6 wks. post-op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David W. Manning

Associate Professor

Northwestern University

研究点 (1)

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