跳至主要内容
临床试验/NCT02500160
NCT02500160Unknown不适用

Comparative Study of Total Knee Arthroplasty Using a Customized-patient Specific Instrument System.

Kyung Hee University Hospital at Gangdong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.

研究概览

简要总结

Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA) as a new technology for improving accuracy in restoration of the alignment and biomechanics of the lower limb. PSI in TKA refers to custom-made cutting jigs manufactured according to the patient's anatomic configuration of distal femur and proximal tibia based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans. MRI- and CT-based PSI systems are available from various manufacturers for preoperative planning. MRI offers precise visualization of articular cartilage without the risk of radiation exposure, but it is expensive and requires long scan times. In contrast, CT enables accurate identification of the contour of the femur and tibia at short scan times, but it does not provide information on the cartilage thickness and carries the risk of radiation exposure. As a result, there is a possibility of some discrepancy between the thickness of bone resection proposed by MRI- or CT-based PSI system and the actual thickness of bone cut. Although PSI has been the focus of study in many recent researches, there has been no clinical study comparing MRI-based and CT-based PSI systems in preoperative planning. Therefore the investigators questioned whether the MRI-based PSI that reflects the cartilage layer would provide more precision in TKA than the CT-based PSI. The purpose of this study was to investigate the accuracy of MRI-based PSI and CT-based PSI in predicting bone resection thickness in TKA.

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Of the patients who had been scheduled for TKA for the treatment of primary osteoarthritis only with varus deformity, those who had been waiting 6 weeks for TKA using an MRI-based or CT-based PSI system and had consented to the relatively new technique were enrolled in the study.

排除标准

  • •Patients with primary osteoarthritis with valgus deformity, rheumatoid arthritis, hemophilic arthritis, posttraumatic arthritis, other inflammatory arthritis, or a history of previous high tibial osteotomy were excluded from the study.

研究组 & 干预措施

patient specific instrumentation (MRI)

Experimental

MRI based patient-specific instrumentation

干预措施: Patient specific instrumentation (MRI) (Device)

patient specific instrumentation (CT)

Active Comparator

CT based patient-specific instrumentation

干预措施: Patient specific instrumentation (CT) (Device)

结局指标

主要结局

The absolute differences (mm) between the planned resection thickness and the actual resection thickness in the femur and the tibia.

时间窗: intraoperative time

After bone resection using a patient-specific cutting jig, the actual thickness of resected bone was measured in 0.1 mm increments by the Vernier caliper (B.Braun-Aesculap, Tuttlingen, Germany) and compared with the planned resection thickness preoperatively using the PSI program.In the MRI group, the intraoperative cutting thickness was compared directly with the preoperatively planned thickness, whereas the presumed thickness of cartilage (2 mm) was added to actual thickness of resected bone from the lateral condyles in the CT group. Finally, the thickness of saw blade (1.27-mm) was added to every resected bone in all cases.

次要结局

  • radiographic assessment(postoperative 6 weeks)

研究者

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

KANG-IL KIM

professor & chairman, department of orthopaedic surgery

Kyung Hee University Hospital at Gangdong

研究点 (1)

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