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临床试验/NCT07122323
NCT07122323Enrolling By Invitation不适用

Comparison of Robotic Arm-assisted THA and Conventional Manual THA in Patients With Legg-Calvé-Perthes Disease: a Prospective Cohort Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
inclination angle

研究概览

简要总结

Flat hip, also called Legg-Calvé-Perthes disease, is clinically characterized by flattened femoral head, shortened femoral neck, and a center of rotation of the femoral head lower than the apex of the greater trochanter. Joint replacement is difficult, with high intraoperative and postoperative complications. Especially, issues such as unequal limb length, postoperative dislocation, postoperative neurological damage, and prosthesis impact have always plagued clinical practice.

The robotic arm-assisted joint replacement technology has been developed and clinically applied for over 10 years, but it was not until the past 3 years that it began to be widely implemented worldwide. Existing research data indicates that robotic arm-assisted joint replacement technology can significantly improve the placement of prostheses and lower limb force lines in patients, and improve their short-term clinical prognosis. However, its application in complex hips, such as flat hip, is limited. More relevant literature is needed to further enrich people's understanding of this technology. In theory, robot assisted technology can solve many challenges faced in flat hip replacement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • patients with Legg-Calvé-Perthes disease and accept total hip replacement in our center

排除标准

  • infection, cannot complete follow-up

结局指标

主要结局

inclination angle

时间窗: 2 days after surgery

The inclination angle in total hip replacement (THR), also called the abduction angle , refers to the angle at which the acetabular cup component is tilted relative to the horizontal plane when viewed on an anteroposterior (AP) pelvic X-ray.

anteversion angle

时间窗: 2 days after surgery

The anteversion angle in total hip replacement (THR) refers to the forward tilt (rotation) of the acetabular cup component around its vertical axis. It determines whether the cup's opening faces more forward or backward relative to the pelvis.

Hospital for Special Surgery Score score (HSS score)

时间窗: before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery

The maximum values is 100, and the minimum value is 0. Higher scores means a better outcome.

次要结局

  • operation duration(during the operation)
  • blood loss(during the operation)
  • Visual Analogue Scale score (VAS score)(before the surgery, 1 week after surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiang Zhao, MD

Principal Investigator

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (1)

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