NCT06726434 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

Eligibility & Interventions

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This trial targets 114 participants in total. It began in 2025-07-09 with a primary completion date of 2029-04-09.

Brief Summary

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.

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 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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