NCT04982198CompletedNot Applicable
Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Mechanical axis alignment
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TKA with conventional surgical instrumentation
Active Comparator
TKA with conventional surgical instrumentation
Intervention: ROSA assisted TKA (Procedure)
TKA assisted with ROSA® Knee System
Experimental
TKA assisted with ROSA® Knee System
Intervention: ROSA assisted TKA (Procedure)
Outcomes
Primary Outcomes
Mechanical axis alignment
Time Frame: 6 weeks (±2 week) postoperatively
Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
Secondary Outcomes
- Coronal Lower Limb Alignment(6 weeks (±2 week) postoperatively)
Investigators
Study Sites (1)
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