Robotic-assisted Versus Conventional Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial

Conditions
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Total Knee Arthoplasty

Intervention / Treatment
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* Procedure: ROSA assisted TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is age between 18 and 85 years old, inclusive; Patient qualifies for a primary TKA based on the investigator's clinical judgement; Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System; Patient is willing and able to provide written Informed Consent. Exclusion Criteria: Patient planning to receive bilateral TKA surgery within 3 months; Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee； Bone tumor patient who has undergone bilateral TKA; Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position; Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA; Patient has active, local infection or previous intra-articular infection in the affected joint; Insufficient bone stock on femoral or tibial surfaces; Skeletal immaturity; Osteomalacia or any metabolic disorder which may impair bone formation; Patient has neurologic disorders (e.g. Stroke); Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis) Patient has a hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum); Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation); Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury; Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin; Patient has severe angular knee deformity of >20° varus or >20° valgus; Patient has a known or suspected sensitivity or allergy to one or more of the implant materials; Patient has other contraindications specified by the implant manufacturer; Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent); In the past 1 month participated in or is participating in clinical trials related to other drugs and medical devices; Any other conditions that the investigator considers inappropriate for participation in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKA assisted with ROSA® Knee System<br>TKA assisted with ROSA® Knee System | Procedure: ROSA assisted TKA<br>* Robotic assisted total knee arthroplasty<br>|
| Active Comparator: TKA with conventional surgical instrumentation<br>TKA with conventional surgical instrumentation | Procedure: ROSA assisted TKA<br>* Robotic assisted total knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical axis alignment | Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively. | 6 weeks (±2 week) postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronal Lower Limb Alignment | Coronal Lower Limb Alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively. | 6 weeks (±2 week) postoperatively |