Clinical trial NCT06856356: Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
Official title: Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: total knee arthroplasty
robot-assisted
alignment
satisfication
complication
Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. The main questions it aims to answer are:

Does the Orthopedic Joint Surgery Navigation System improve the accuracy of prosthetic component placement in knee replacement surgery? Is the Orthopedic Joint Surgery Navigation System superior to traditional total knee replacement What medical problems do participants encounter when taking medication ABC? Researchers will compare the Orthopedic Joint Surgery Navigation System with traditional total knee replacement surgery (using a "four-in-one" osteotomy guide) to see if the Orthopedic Joint Surgery Navigation System is superior to traditional total knee replacement in terms of prosthesis three-dimensional position, force alignment, patient satisfaction, functional scores, complications, etc.

Participants will:

End-stage knee osteoarthritis patients receive total knee replacement with the Orthopedic Joint Surgery Navigation System or traditional total knee replacement surgery Visit the clinic for examination and testing every 3 months Record their imaging data, satisfaction, functional scores, complications, etc.

Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily participate in the trial and sign the informed consent form;
2. Aged 18 to 80 years old (inclusive), regardless of gender;
3. Patients who need total knee replacement surgery;
4. Those who can communicate well with the researchers and comply with the trial requirements.

Exclusion Criteria:

1. Patients who are allergic to the drugs used in this trial or the implant materials;
2. Patients with immature bone development;
3. Patients with active infection;
4. Patients with neuropathy of the knee joint;
5. Patients with poor bone quality that is not conducive to prosthesis fixation;
6. Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
7. Patients with insufficient quadriceps muscle strength;
8. Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
9. Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
10. Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
11. Pregnant or lactating women;
12. Patients with severe epilepsy or mental illness;
13. Patients with alcohol dependence or drug addiction;
14. Patients with severe coagulation disorders;
15. Patients who have participated in or are participating in other clinical trials within one month of enrollment;
16. Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.

Primary outcomes:
measure: Postoperative patient satisfaction
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
measure: Forgotten Joint Scores
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
measure: WOMAC score
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
measure: Knee Society Score
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
Secondary outcomes:
measure: SF-12
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
measure: visual analogue scale score
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
measure: Range of motion
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
measure: Hip-knee-ankle angle
timeFrame: postoperative Day 1-3
measure: Complication
timeFrame: Month 1, Month 3, Month 6, Month 12, Month 24
Other outcomes:
measure: mLDFA
timeFrame: preoperative Day 1-3, postoperative Day 1-3
measure: mMPTA
timeFrame: preoperative Day 1-3, postoperative Day 1-3
measure: Femoral prosthesis flexion angle (α angle)
timeFrame: preoperative Day 1-3, postoperative Day 1-3
measure: Tibial posterior tilt angle (β angle):
timeFrame: preoperative Day 1-3, postoperative Day 1-3
Locations:
city: Hefei
country: China
facility: the first affiliated hospital of USTC
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC
name: Chen Zhu, M.D
role: PRINCIPAL_INVESTIGATOR
References: