Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).

NACompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

April 17, 2018

Primary Completion Date

July 10, 2020

Study Completion Date

January 21, 2022

Conditions
Osteoarthritis Of Knee
Interventions
PROCEDURE

internal PUC implanted with mechanical ancillary

The control group consists of patients operated with a mechanical ancillary (reference surgery in our department). In this technique, bone sections are made with a standardized ancillary (manually adjusted bone cutting guides), according to preoperative radiological planning. The positioning of the implants is done manually and controlled by the placement of test implants.

PROCEDURE

Internal PUC implanted with robotic assistance

Patients are operated by robotics (surgery that we want to develop systematically in our service). 3D modeling of the knee allows the operator to perform a dynamic planning taking into account the reducibility of the deformation and the model of the implant. The operator can position the implants in three dimensions of the space without difficulty. This makes it possible to visualize, before the bone resections, the angular correction obtained between 0 and 130° flexion and alignment of the prosthesis by visualizing the contact points between the two implants. Bone resections will be performed using a guided retro bone drill. The system retracts more or less the cutter according to the bone thickness to be removed. This technique requires the insertion of two threaded plugs in the tibia and two in the femur to position the sensors that will allow the acquisition of anatomical landmarks of the lower limb and then 3D modeling

Trial Locations (1)

69004

Hopital de la Croix Rousse, Lyon

All Listed Sponsors
collaborator

Smith & Nephew, Inc.

INDUSTRY

lead

Hospices Civils de Lyon

OTHER

NCT03469193 - Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). | Biotech Hunter | Biotech Hunter