Correlation Between Preoperative Knee Extension Lag and Functional Outcome After Total Knee Arthroplasty

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05833152
Collaborator
(none)
80
26.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: total knee arthroplasty

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.

  1. 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.

  1. Data analysis

  2. 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.

  3. 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

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlation Analysis of Knee Extension Lag Angle and Knee Function After Total Knee Arthroplasty
Anticipated Study Start Date :
Apr 17, 2023
Anticipated Primary Completion Date :
Apr 17, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
<5°

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

5-10°

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

10-15°

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

≥15°

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

Outcome Measures

Primary Outcome Measures

  1. WOMAC [three months after surgery]

    Knee functional scale

Secondary Outcome Measures

  1. Thickness of vastus medialis muscle [three months after surgery]

    muscle thickness

  2. range of motion [three months after surgery]

    Reflect knee function

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Study Chair: Yang yanyan, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05833152
Other Study ID Numbers:
  • M2022846
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 27, 2023