Robotic-assisted Versus Conventional Total Knee Arthroplasty

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    156
  • sponsor
    Zimmer Biomet
Updated on 16 August 2021

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.

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).

Details
Condition Total Knee Arthoplasty
Treatment ROSA assisted TKA
Clinical Study IdentifierNCT04982198
SponsorZimmer Biomet
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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