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

Osteoarthritis Of Knee Clinical Trial

— PUC NAVIO  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469193
• Other study ID #: 69HCL17_0512
• Secondary ID: 2017-A03292-51
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: January 21, 2022

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 21, 2022
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female adult (age = 18 years)
• Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI))
• Indication of unicompartmental knee arthroplasty of first intention posed

Exclusion Criteria:

• History of femoral or tibial osteotomy of valgization or varisation
• Reconstruction of the associated cruciate ligament
• Refusal to participate in the study
• Pregnant women, parturient or nursing mothers
• Persons deprived of their liberty by a judicial decision or administrative staff, persons under psychiatric care, persons admitted to a health or social institution to other purposes.
• Major persons subject to a legal protection measure or unable to express their consent
• Patient not affiliated to a social security scheme
• Patient participating in another interventional research excluding routine care research (former regulation) and category 2 searches not interfering with criterion analysis main

Related Conditions & MeSH terms

• Osteoarthritis Of Knee
• Osteoarthritis, Knee

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Hopital de la Croix Rousse	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Smith & Nephew, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.	This criterion will be measured using a KneeKG system for dynamic analysis of knee movements.; This system is non-invasive, non-radiating, non-painful. It is a dynamic tibiofemoral tracing device by infrared camera validated. The KneeKG system will be used according to its instructions for use.	At 6 month postsurgery
Secondary	Radiological positioning of implants	Measurements of HKA, frontal alignment of tibial and femoral implants, sagittal alignment of the femoral implant, tibial implant slope and the presence of peri-prosthetic edgings will be performed on a Standard radiography of the knee operated from the front, in profile and on a standing pangonometry	At 6 month and 24 month postsurgery
Secondary	Comparison of the means of the International Knee Society (IKS) overall score between the groups.	This is the international benchmark for clinical and functional evaluation in knee surgery. The 2011 version provides a more accurate, complete and comprehensive vision than the previous version.	At 6 month and 24 month postsurgery
Secondary	Comparison of the Forgotten Joint Score	The Forgotten score helps to analyze the patient's attention to the fact that his articulation has been replaced.	At 6 month and 24 month postsurgery