Clinical trial NCT03469193: Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Of Knee
Keywords: knee unicompartmental prosthesis
KneeKG system
robotic-assisted
alignment
implants positioning
International Knee Society
Forgotten joint score
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2018-03-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At 6 month postsurgery
Secondary outcomes:
measure: Radiological positioning of implants
timeFrame: At 6 month and 24 month postsurgery
measure: Comparison of the means of the International Knee Society (IKS) overall score between the groups.
timeFrame: At 6 month and 24 month postsurgery
measure: Comparison of the Forgotten Joint Score
timeFrame: At 6 month and 24 month postsurgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Sebastien Lustig
role: PRINCIPAL_INVESTIGATOR
References: