Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Knee Arthoplasty
- Sponsor
- Zimmer Biomet
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Mechanical axis alignment
- Status
- Completed
- Last Updated
- 2 years ago
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).
Investigators
Eligibility Criteria
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);
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)