NCT05391152

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	robotic assisted total knee replacement	the study group used robotic-arm assisted total knee replacement.
DEVICE	traditional total knee replacement	the control group used traditional total knee replacement

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-05-01
• Completion: 2025-10-01
• First posted: 2022-05-25
• Last updated: 2022-05-25