This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.
The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Robotic assisted total knee arthroplasty
PLA Hospital
Beijing, Beijing Municipality, China
Mechanical axis alignment
Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
Time frame: 6 weeks (±2 week) postoperatively
Coronal Lower Limb Alignment
Coronal Lower Limb Alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
Time frame: 6 weeks (±2 week) postoperatively
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