Comparing two nerve-treatment procedures for foot deformity after stroke
Compares freezing nerves with surgical cutting for stiff, turned-in feet after stroke.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Garches, Montpellier, Poitiers, Rennes, Saint-Etienne, and Toulouse, FranceSee the 7 sites
Where in France
- Hôpital Raymond PointcarréGarches, FranceTaking people
- CHRU MontpellierMontpellier, FranceTaking people
- C.H.U. PoitiersPoitiers, FranceTaking people
- CHU RennesRennes, FranceTaking people
- Pôle Saint HélierRennes, FranceTaking people
- CHU Saint-EtienneSaint-Etienne, FranceTaking people
- Hopital PurpanToulouse, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Poitiers University Hospital
- Trial code
- NCT06726434
- Record updated
- 25 February 2026
- Original description
CRYOSTROKE study is designed :Read full original descriptionShow less
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: a Multicenter, Randomized Controlled, Non-inferiority Trial
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.
Inclusion: 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: Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site; 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; 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); 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…).); Patient with any neurological pathology different from the one responsible for the spasticity; Patient with total deficit of valgus muscles; Patient with equinus foot > 40° (retractions/ankylosis); 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.