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Clinical Trial Summary

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


Clinical Trial Description

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. 4. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05833152
Study type Observational
Source Peking University Third Hospital
Contact Yang yanyan
Phone 13501348579
Email yyykaixin@163.com
Status Not yet recruiting
Phase
Start date April 17, 2023
Completion date June 30, 2025

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