CompletedNot Applicable

Robotic-assisted Versus Conventional Total Knee Arthroplasty

China99 participantsStarted 2021-07-07

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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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;

What they're measuring

Mechanical axis alignment

Timeframe: 6 weeks (±2 week) postoperatively

Trial details

NCT IDNCT04982198

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Total Knee Arthoplasty trials