Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
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.
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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 presenting no cognitive impairment or major depression (Mini Mental State Examination\>20, Hospital Anxiety and Depression (HAD\<11)).
* Absence of active psychosis or history of serious psychotic illness requiring hospitalization
* Patient understanding and accepting the constraints of the study.
* Patient covered by French national health insurance.
* Patient who has given their written consent to the study after having received clear information.
Exclusion Criteria:
* 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.
* Patient with total deficit of valgus muscles.
* Patient with equinus foot \> 40° (retractions/ankylosis).
* Surgical and anesthetic contra-indications (severe uncontrolled coagulation disorder, active infection).
* Cryoneurotomy contra-indications (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomena, venous thromboemolism (\< 3 months if superficial, \< 6 months if deep), hypothyreosis, cold urticari, local disorders of blood supply, considerable anemia, cachexia, hypothermia, cancer disease, infection, coagulopathy…).).
* Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection (temporary or permanent guardianship and, subject to subordination), and finally patients in an emergency setting.
* Pregnant woman, nursing mother, woman of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).
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