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

Zhejiang University

Status: Not yet enrolling

Conditions: Osteoarthritis, Knee

Treatments: Device: traditional total knee replacement; Device: robotic assisted total knee replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT05391152

202203

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

robotic-arm assisted modified kinematic alignment total knee replacement

Experimental group

Description:

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

Treatment:

Device: robotic assisted total knee replacement

traditional manual total knee replacement

Active Comparator group

Description:

The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.

Treatment:

Device: traditional total knee replacement