NCT03469193

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

Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result. Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved. The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance. The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith \& Nephew). The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.

Conditions

• Osteoarthritis Of Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-04-17
• Primary completion: 2020-07-10
• Completion: 2022-01-21
• First posted: 2018-03-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: France