Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty
NCT ID: NCT06856356
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-04-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Robot-assisted total knee arthroplasty
Using an orthopedic joint surgery navigation system to assist total knee replacement
Robot-assisted surgery
Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
Conventional total knee arthroplasty
Using a conventional 4-in-1 osteotomy guide for total knee replacement
Conventional total knee arthroplasty
Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide
Interventions
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Robot-assisted surgery
Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
Conventional total knee arthroplasty
Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
80 Years
ALL
No
Sponsors
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The First Affiliated Hospital of University of Science and Technology of China
OTHER
Responsible Party
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Principal Investigators
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Chen Zhu, M.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of USTC
Locations
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the first affiliated hospital of USTC
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Chen Zhu, M.D
Role: primary
Other Identifiers
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XJS2023-1-18(WK)
Identifier Type: -
Identifier Source: org_study_id
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