Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). (PUC NAVIO)
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Study type
Funder types
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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