Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of University of Science and Technology of China

About this trial

The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in the trial and sign the informed consent form;

Aged 18 to 80 years old (inclusive), regardless of gender;

Patients who need total knee replacement surgery;

Those who can communicate well with the researchers and comply with the trial requirements.

Disqualifiers

Patients who are allergic to the drugs used in this trial or the implant materials;

Patients with immature bone development;

Patients with active infection;

Patients with neuropathy of the knee joint;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robot-assisted surgery

    Procedure/Surgery

    Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system

  • Conventional total knee arthroplasty

    Procedure/Surgery

    Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Robot-assisted total knee arthroplastyExperimental treatment 1 intervention
Group B: Conventional total knee arthroplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative patient satisfaction

Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24
2

Forgotten Joint Scores

The Forgotten Joint Score (FJS) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty.The total score is 100 points. The higher the score, the better the degree of forgetfulness of the artificial joint.

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24
3

WOMAC score

Use WOMAC scoring scale to assess the condition of the knee joint. The WOMAC score consists of 24 items with a total score of 100. The higher the score, the more severe the limitation of joint function.

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24
4

Knee Society Score

The KSS score was assessed using the American Knee Society scoring criteria.The full score is 100 points. The higher the score, the better the patient's knee function.

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24

Secondary outcomes

1

SF-12

The health status of patients was assessed using the SF-12 health-related quality of life scale. The higher the score, the better the quality of life.

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24
2

visual analogue scale score

Visual analogue scale (VAS) for pain assessment。0 means no pain, 10 means the most painful, the higher the value, the higher the pain level of the patient

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24
3

Range of motion

Physical examination to assess the knee's range of motion

Time frame
Month 1, Month 3, Month 6, Month 12, Month 24
4

Hip-knee-ankle angle

Measuring Hip-knee-ankle angle in radiology

Time frame
postoperative Day 1-3

Other outcomes

1

mLDFA

the lateral angle between the mechanical axis of the femur and the tangent of the distal end of the femoral prosthesis. The target value is 90°. \>90° is varus, and \<90° is valgus. Varus or valgus exceeding 3° is defined as femoral prosthesis position deviation.

Time frame
preoperative Day 1-3, postoperative Day 1-3
2

mMPTA

medial angle between the mechanical axis of the tibia and the tangent of the tibial prosthesis, the target value is 90°, \<90° is varus, \>90° is valgus, and valgus exceeding 3° is defined as tibial prosthesis position deviation

Time frame
preoperative Day 1-3, postoperative Day 1-3
3

Femoral prosthesis flexion angle (α angle)

on the standard lateral knee X-ray, the angle between the anatomical axis of the distal femur and the vertical line of the distal femoral prosthesis

Time frame
preoperative Day 1-3, postoperative Day 1-3
4

Tibial posterior tilt angle (β angle):

on the standard lateral knee X-ray, the angle between the anatomical axis of the tibia and the lower surface of the tibial prosthesis.

Time frame
preoperative Day 1-3, postoperative Day 1-3

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