Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT05391152
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- age between 18 years and 85 years
- primary total knee replacement
- obvious bone defect
- infection
- BMI>>35kg/m2
- severe osteoporosis
- mental disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method KSS score 3 months Keen Society Score
- Secondary Outcome Measures
Name Time Method mLDFA 3 months mechanical lateral distal femoral angle
mMPTA 3 months mechanical medial proximal tibial angle
SFCA 3 months sagittal femoral component angle
knee ROM 3 months knee range of motion
blood loss intraoperative the intraoperative blood loss
surgical duration intraoperative the duration of the operation
complication 3 months complications after the surgery
HKA angle 3 months hip-knee-ankle angle