CRYOSTROKE study is designed :
* to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and, * to ensure that potential clinical effect/safety remain stable within time, with a 12-month follow-up.
Age ≥18 years old.
Patient with spastic equinovarus foot as a result of stroke in chronic phase (>6 months).
Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus.
Patient eligible for surgical neurotomy for varus equinus foot.
Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site.
Patient with any neurological pathology different from the one responsible for the spasticity.
Patient with botulinum toxin in lower limb injection during the last 90 days before intervention.
Patient with anti-spastic treatment (baclofene) up 3 days before block test.
Parallel
Surgical neurotomy (SN)
Procedure/SurgerySurgical neurotomy will be performed under general anesthesia according to the previous description. Muscle relaxant drugs will not be used in order to prevent any interference with the intraoperative electrical stimulation. The patient will be placed in a prone position and a vertical cutaneous incision will be made at the popliteal fossa location. The tibial nerve will be dissected and the motor nerve branches of the soleus, gastrocnemius, tibialis posterior and flexor hallucis longus will be identified with intraoperative tripolar electrical stimulation. The selected motor nerve branches will be partially sectioned over a 5mm length under the microscope. The extent of nerve section will be determined according to the degree of spasticity and to the intraoperative residual muscular contraction under electrical stimulation
Cryoneurotomy (CN)
Procedure/SurgeryAfter the use of an aseptic technique with 2% chlorhexidine, betadine application and a local anesthesia with lidocaine 1% (3ml), percutaneous cryoneurotomy will be performed with METRUM CRYOFLEX device guided by ultrasound with 1.2mm cryoprobe at -89°C placed through a #16 angio guide. Electrical stimulation will be performed to confirm tibial nerve contact at 0.8 mV. The ice ball will be repositioned to two spots along the nerve. Each lesion will be treated for 2min cryoneurolysis at -89°C, followed by 2min without freezing (passive defreezing period) and 2min of cryoneurolysis at -89°C, based on cryotherapy for pain management.
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity).
Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity). This MAS will be quantified on a passive ankle dorsal flexion with knee extended (180°) movement.
Mean absolute change in functional disability assessed using the Barthel Index (BI).
Mean absolute change in passive ankle dorsal flexion with knee flexed (90°) and extended (180°) movement spasticity assessed by the Modified Ashworth Scale (MAS)
Mean absolute change in muscle's response to stretch applied at given velocities assessed by the Tardieu Scale and the Modified Tardieu Scale (MTS)
Mean absolute change in maximal ankle range of motion (in degrees) assessed with a goniometer in slow and rapid movement
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