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

Not Applicable

Completed

• Conditions: Osteoarthritis Of Knee
• Interventions: Procedure: internal PUC implanted with mechanical ancillary; Procedure: Internal PUC implanted with robotic assistance

• Registration Number: NCT03469193
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2018-04-17
• Primary Completion: 2020-07-10
• Study Completion: 2022-01-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
internal PUC implanted with mechanical ancillary	internal PUC implanted with mechanical ancillary	-
Internal PUC implanted with robotic assistance	Internal PUC implanted with robotic assistance	-

Primary Outcome Measures

Name	Time	Method
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.	At 6 month postsurgery	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.

Secondary Outcome Measures

Name	Time	Method
Radiological positioning of implants	At 6 month and 24 month postsurgery	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
Comparison of the means of the International Knee Society (IKS) overall score between the groups.	At 6 month and 24 month postsurgery	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.
Comparison of the Forgotten Joint Score	At 6 month and 24 month postsurgery	The Forgotten score helps to analyze the patient's attention to the fact that his articulation has been replaced.

Trial Locations

Locations (1)

Hopital de la Croix Rousse; 🇫🇷 Lyon, France