60
Participants
Start Date
January 2, 2024
Primary Completion Date
March 2, 2027
Study Completion Date
March 2, 2027
Tibial nerve selective neurotomy
Patients in the STN group will undergo a pre-anaesthetic visit before surgery to validate the possibility of general anesthesia. The surgery will be performed at maximum 3 months after inclusion. The muscles that have been defined pre-randomization will be targeted by the surgery. The duration of the surgery is about 1 hour and 30 minutes.
Botulinum toxin injection
Patients in the BoNT group will be treated with BoNT A under electromyography, electrical stimulation and/or ultrasound guidance (V0). In the absence of scientific evidence between the efficacy of onabotulinumtoxin A and abobotulinumtoxin A, physician will be free to choose between these two BoNT formulation which are both authorized for the treatment of lower limb spasticity. The physician will determine the muscles targeted by the BoNT (gastrocnemius and soleus for equinus, posterior tibialis for varus, and long flexor digitorum and flexor hallucis for claw toes), the appropriate dose and dilution based on his experience, following a semi-guided table of equivalence for respective doses of onabotulinumtoxin A and abobotulinumtoxin A. A delay superior to 3 months will be respected after the last injection and the muscles that have been defined pre-randomization will be targeted by injections.
NOT_YET_RECRUITING
CHU de Nantes, Nantes
RECRUITING
Hôpital Henry Gabrielle, Saint-Genis-Laval
NOT_YET_RECRUITING
Hôpital Pierre Wertheimer, Bron
NOT_YET_RECRUITING
AP-HP, Clichy
Hospices Civils de Lyon
OTHER