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临床试验/NCT05833152
NCT05833152已完成不适用

Correlation Analysis of Knee Extension Lag Angle and Knee Function After Total Knee Arthroplasty

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
WOMAC

研究概览

简要总结

To explore the relationship between different knee extension hysteresis angles and functional outcome of knee joint after total knee replacement

详细描述

  1. Collect perioperative baseline data

Subjects were recruited and perioperative baseline data were collected: ① Demographic information, including age, sex, height, weight, affected knee, etc. ②Body structure and function: joint motion, knee extension hysteresis angle, pain NRS, WOMAC assessment, and ultrasonic knee extension mechanism were measured before and 3 days after surgery. 2. Postoperative follow-up

The patients were followed up for 3 months, and 6 weeks /3 months after surgery was selected as the follow-up node. The follow-up included postoperative range of motion, knee extension hysteresis Angle, pain NRS, WOMAC assessment, ultrasonic measuring knee extension mechanism, TUG Test (Timed Up-to-go Test), isometric muscle force test, balance postural graph, gait analysis, etc. 3. Data analysis

  1. Multi-factor regression analysis was performed to determine the main outcome indicators of WOMAC evaluation at 3-month follow-up, including range of motion, Angle of knee extension hysteria, pain NRS, ultrasonic knee extension device, TUG Test (Timed Up-to-go Test), isoktatic muscle force test, balance postural graph and secondary outcome indicators of gait analysis. The perioperative knee extension hysteresis Angle was used as the independent variable to construct the postoperative regression model of knee function.
  2. According to the Angle of knee extension hysteresis in perioperative period, patients were divided into 4 groups: ≤5°, 5-10°11-15°, ≥15°, The results of range of motion, knee extension hysteresis Angle, pain NRS, WOMAC score, ultrasonic knee extension device, TUG Test (Timed Up to go Test), iso-tachykinesis test, balance postural mapping and gait analysis were compared among all groups 3 months after surgery.
  3. Study outcome

Follow-up was completed; The patient underwent revision surgery for knee osteoarthritis. The patient dropped out of the trial for personal reasons; Other unforeseen circumstances prevented the patient from continuing the trial.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Patients who meet the diagnostic criteria of knee osteoarthritis (age >45 years old); (2) Patients admitted to the Department of Orthopedics of the Third Hospital of Beijing Medical University and preparing to receive TKA surgery; (3) The patient has good cognitive function and good compliance, and can cooperate with various examinations; (4) Voluntarily participate in the study and sign the informed consent;

排除标准

  • (1) Patients with lower extremity fracture and severe lumbar spinal stenosis that affect postoperative functional recovery; (2) Patients with severe cerebrovascular disease who cannot cooperate with postoperative rehabilitation exercise; (3) The time interval of double knee replacement was less than 3 months.

结局指标

主要结局

WOMAC

时间窗: three months after surgery

Knee functional scale

次要结局

  • range of motion(three months after surgery)
  • Thickness of vastus medialis muscle(three months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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