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

Not Applicable

Not yet recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Device: robotic assisted total knee replacement; Device: traditional total knee replacement

• 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

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Study Start: 2022-09-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic-arm assisted modified kinematic alignment total knee replacement	robotic assisted total knee replacement	The patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment.
traditional manual total knee replacement	traditional total knee replacement	The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.

Primary Outcome Measures

Name	Time	Method
KSS score	3 months	Keen Society Score

Secondary Outcome Measures

Name	Time	Method
HKA angle	3 months	hip-knee-ankle angle
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