Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement

Study Overview
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Brief Summary
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This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.

Official Title
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Comparison Between Robotic-Arm Assisted Modified Kinematic Alignment Total Knee Replacement And Traditional Manual Alignment Total Knee Replacement：A Prospective Multicenter, Double-Blind Study

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: robotic assisted total knee replacement
* Device: traditional total knee replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 years and 85 years primary total knee replacement Exclusion Criteria: obvious bone defect infection BMI>>35kg/m2 severe osteoporosis mental disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic-arm assisted modified kinematic alignment total knee replacement<br>The patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment. | Device: robotic assisted total knee replacement<br>* the study group used robotic-arm assisted total knee replacement.<br>|
| Active Comparator: traditional manual total knee replacement<br>The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment. | Device: traditional total knee replacement<br>* the control group used traditional total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS score | Keen Society Score | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HKA angle | hip-knee-ankle angle | 3 months | 
| mLDFA | mechanical lateral distal femoral angle | 3 months | 
| mMPTA | mechanical medial proximal tibial angle | 3 months | 
| SFCA | sagittal femoral component angle | 3 months | 
| knee ROM | knee range of motion | 3 months | 
| blood loss | the intraoperative blood loss | intraoperative | 
| surgical duration | the duration of the operation | intraoperative | 
| complication | complications after the surgery | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic-arm assisted, total knee replacement, kinematic alignment