Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05391152
Enrollment
100
Registered
2022-05-25
Start date
2022-09-01
Completion date
2025-10-01
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

robotic-arm assisted, total knee replacement, kinematic alignment

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.

Interventions

DEVICErobotic assisted total knee replacement

the study group used robotic-arm assisted total knee replacement.

the control group used traditional total knee replacement

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
KSS score3 monthsKeen Society Score

Secondary

MeasureTime frameDescription
mLDFA3 monthsmechanical lateral distal femoral angle
mMPTA3 monthsmechanical medial proximal tibial angle
SFCA3 monthssagittal femoral component angle
HKA angle3 monthship-knee-ankle angle
blood lossintraoperativethe intraoperative blood loss
surgical durationintraoperativethe duration of the operation
complication3 monthscomplications after the surgery
knee ROM3 monthsknee range of motion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026