Osteoarthritis, KneeNCT06856356
Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
A study testing Robot-assisted surgery and Conventional total knee arthroplasty in people with Osteoarthritis, Knee, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Robot-assisted surgery and Conventional total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of USTC
Hefei, Anhui, 230001
Chen Zhu, M.D
About this study
Official title: Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Robot-assisted surgery, Conventional total knee arthroplasty
- Keywords
- total knee arthroplasty, robot-assisted, alignment, satisfication, complication
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted surgeryProcedure or surgery
Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
Conventional total knee arthroplastyProcedure or surgery
Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted total knee arthroplasty | Experimental | Using an orthopedic joint surgery navigation system to assist total knee replacement Receives: Procedure: Robot-assisted surgery |
| Conventional total knee arthroplasty | Active comparator | Using a conventional 4-in-1 osteotomy guide for total knee replacement Receives: Procedure: Conventional total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative patient satisfaction
Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1, Month 3, Month 6, Month 12, Month 24
Secondary outcomes (5)
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.
Measured: Month 1, Month 3, Month 6, Month 12, Month 24
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
Measured: Month 1, Month 3, Month 6, Month 12, Month 24
Range of motion
Physical examination to assess the knee's range of motion
Measured: Month 1, Month 3, Month 6, Month 12, Month 24
Hip-knee-ankle angle
Measuring Hip-knee-ankle angle in radiology
Measured: postoperative Day 1-3
Complication
Record the patient's postoperative complications. For example, Persistent pain, fracture, superficial local infection, infection, thromboembolism.
Measured: Month 1, Month 3, Month 6, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Apr 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Zhu, M.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856356
- Sponsor's protocol ID
- XJS2023-1-18(WK)
- Status last verified
- Feb 2025
- First submitted
- 14 Aug 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06856356
- Acronym / sponsor ID
- XJS2023-1-18(WK)
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee arthroplasty, robot-assisted, alignment, satisfication, complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted total knee arthroplasty | Experimental | Procedure: Robot-assisted surgeryUsing an orthopedic joint surgery navigation system to assist total knee replacement |
| Conventional total knee arthroplasty | Active comparator | Procedure: Conventional total knee arthroplastyUsing a conventional 4-in-1 osteotomy guide for total knee replacement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted surgeryOrthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system | Procedure or surgery | Robot-assisted total knee arthroplasty |
| Conventional total knee arthroplastyOrthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide | Procedure or surgery | Conventional total knee arthroplasty |
Primary outcome
Postoperative patient satisfaction
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Use a questionnaire to investigate patients' satisfaction with their knee joint after surgery
Forgotten Joint Scores
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
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.
WOMAC score
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
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.
Knee Society Score
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
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.
5 secondary outcomes
SF-12
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
visual analogue scale score
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Range of motion
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Hip-knee-ankle angle
Time frame: postoperative Day 1-3
Complication
Time frame: Month 1, Month 3, Month 6, Month 12, Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen Zhu, M.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted surgery and Conventional total knee arthroplasty in people with Osteoarthritis, Knee, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianzuo Zhang, Ph.D (+8618556533086, zhangxianzuo@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative patient satisfaction (time frame: Month 1, Month 3, Month 6, Month 12, Month 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.