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

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

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

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Extension Lag
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to the Department of Orthopaedics of Peking University Third Hospital for total knee arthroplasty

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC	Knee functional scale	three months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of vastus medialis muscle	muscle thickness	three months after surgery
range of motion	Reflect knee function	three months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Yang yanyan, Peking University Third Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: M2022846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No