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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05391152
• Other study ID #: 202203
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: March 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• robotic assisted total knee replacement
the study group used robotic-arm assisted total knee replacement.
• traditional total knee replacement
the control group used traditional total knee replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KSS score	Keen Society Score	3 months
Secondary	HKA angle	hip-knee-ankle angle	3 months
Secondary	mLDFA	mechanical lateral distal femoral angle	3 months
Secondary	mMPTA	mechanical medial proximal tibial angle	3 months
Secondary	SFCA	sagittal femoral component angle	3 months
Secondary	knee ROM	knee range of motion	3 months
Secondary	blood loss	the intraoperative blood loss	intraoperative
Secondary	surgical duration	the duration of the operation	intraoperative
Secondary	complication	complications after the surgery	3 months