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Clinical Trials/NCT05833152
NCT05833152
Completed
N/A

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

Peking University Third Hospital1 site in 1 country48 target enrollmentMay 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Extension Lag
Sponsor
Peking University Third Hospital
Enrollment
48
Locations
1
Primary Endpoint
WOMAC
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
May 31, 2024
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • (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;

Exclusion Criteria

  • (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.

Outcomes

Primary Outcomes

WOMAC

Time Frame: three months after surgery

Knee functional scale

Secondary Outcomes

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

Study Sites (1)

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