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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05833152
Other study ID # M2022846
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 17, 2023
Est. completion date June 30, 2025

Study information

Verified date April 2023
Source Peking University Third Hospital
Contact Yang yanyan
Phone 13501348579
Email yyykaixin@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date June 30, 2025
Est. primary completion date April 17, 2025
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
total knee arthroplasty
To observe the postoperative functional outcome of patients with knee extension lag at different angles

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

References & Publications (1)

McGinn TL, Etcheson JI, Gwam CU, George NE, Mohamed NS, Mistry JB, Ananaba U, Bhave A. Short-term outcomes for total knee arthroplasty patients with active extension lag. Ann Transl Med. 2018 Jun;6(11):204. doi: 10.21037/atm.2018.05.38. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary WOMAC Knee functional scale three months after surgery
Secondary Thickness of vastus medialis muscle muscle thickness three months after surgery
Secondary range of motion Reflect knee function three months after surgery
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