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临床试验/NCT04960345
NCT04960345Unknown不适用

Comparison of Accuracy and Clinical Outcomes Between Brainlab Knee 3 Computer-assisted Navigation Systems and Conventional Instruments in TKA: a Prospective Cohort Study

Peking University Third Hospital0 个研究点目标入组 188 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
188
主要终点
lower limb alignment

研究概览

简要总结

This is a a prospective cohort study. According to the inclusion criteria, volunteers were recruited from patients undergoing total knee arthroplasty. The patients are devided into two groups: the conventional TKA,the computer-assisted surgery(CAS) using Brainlab Knee 3 system.The differences of postoperative alignment,operative time,blood loss will be studied between the two groups.Clinical and functional evaluation using the scoring system of HSS(Hospital for Special Surgery) score, Western Ontario and McMaster University osteoarthritis index (WOMAC), Forgotten joint score(FJS-12) will be compared between the 2 groups,after surgery, and at the follow-up of 3 months、6 months and 12 months.

详细描述

According to the inclusion criteria, patients receiving primary total knee arthroplasty were recruited and divided into two groups after doctor-patient joint decision: the traditional group underwent prosthesis placement using traditional intramedullary positioning method;The navigation group performed surgery using the Brainlab Knee 3 navigation system.Informed consent was signed after grouping. All patients were operated by the same knee prosthesis system. Both groups underwent the same procedures such as the installation of the soft tissue adjustment, prosthesis placement, wound closure and so on.All patients were given the same perioperative treatment, such as hemostasis, anti-infection and analgesia, and routine postoperative rehabilitation exercises. The full length anteroposterior and lateral radiographs of both lower extremities in weight-bearing position were taken preoperatively and one week postoperatively.The differences of postoperative alignment,operative time,blood loss will be studied between the two groups.Clinical and functional evaluation using the scoring system of HSS(Hospital for Special Surgery) score, Western Ontario and McMaster University osteoarthritis index (WOMAC), Forgotten joint score(FJS-12) will be compared between the 2 groups,after surgery, and at the follow-up of 3 months、6 months and 12 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

lower limb alignment

时间窗: Within 1 week after surgery

knee-ankle angle (HKA) and components placement using coronal femoral-component angle (CFA) and coronal tibia- component angle (CTA)、sagittal femoral-component angle (SFA) and sagittal tibia-component angle(STA).

次要结局

  • Operation time(Immediately after surgery)
  • HSS(Hospital for Special Surgery) score(6 months and 12 months after surgery)
  • the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(3 months、6 months and 12 months after surgery)
  • Blood loss(3 days after surgery)
  • Forgotten Joint Score-12 (FJS-12)(6 months and 12 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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