Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

NCT06856356 | Recruiting DMC

• 1 other identifier: XJS2023-1-18(WK)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

total knee arthroplasty; robot-assisted; alignment; satisfication; complication

Outcome Measures

Primary Outcomes (4)

• Postoperative patient satisfaction

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

  Month 1, Month 3, Month 6, Month 12, Month 24

• 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.

  Month 1, Month 3, Month 6, Month 12, Month 24

• 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.

  Month 1, Month 3, Month 6, Month 12, Month 24

• 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.

  Month 1, Month 3, Month 6, Month 12, Month 24

Secondary Outcomes (5)

• SF-12

  Month 1, Month 3, Month 6, Month 12, Month 24

• visual analogue scale score

  Month 1, Month 3, Month 6, Month 12, Month 24

• Range of motion

  Month 1, Month 3, Month 6, Month 12, Month 24

• Hip-knee-ankle angle

  postoperative Day 1-3

• Complication

  Month 1, Month 3, Month 6, Month 12, Month 24

Other Outcomes (4)

• mLDFA

  preoperative Day 1-3, postoperative Day 1-3

• mMPTA

  preoperative Day 1-3, postoperative Day 1-3

• Femoral prosthesis flexion angle (α angle)

  preoperative Day 1-3, postoperative Day 1-3

Study Arms (2)

Robot-assisted total knee arthroplasty

EXPERIMENTAL

Using an orthopedic joint surgery navigation system to assist total knee replacement

Procedure: Robot-assisted surgery

Conventional total knee arthroplasty

ACTIVE COMPARATOR

Using a conventional 4-in-1 osteotomy guide for total knee replacement

Procedure: Conventional total knee arthroplasty

Interventions

Robot-assisted surgery PROCEDURE

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

Robot-assisted total knee arthroplasty

Conventional total knee arthroplasty PROCEDURE

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

Conventional total knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with poor bone quality that is not conducive to prosthesis fixation;
• Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
• Patients with insufficient quadriceps muscle strength;
• Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
• Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
• Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
• Pregnant or lactating women;
• Patients with severe epilepsy or mental illness;
• Patients with alcohol dependence or drug addiction;
• Patients with severe coagulation disorders;
• Patients who have participated in or are participating in other clinical trials within one month of enrollment;

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

the first affiliated hospital of USTC

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Chen Zhu, M.D

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianzuo Zhang, Ph.D

CONTACT

+8618556533086; zhangxianzuo@foxmail.com

Xianyue Shen, M.D

CONTACT

17843122928; shenxianyue0616@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are independent of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: March 4, 2025
• Study Start: April 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

CN (1)