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
Recruiting now · Not applicable
Conditions studied: Stroke, Equinovarus Foot, Refractory Lower Limb Spasticity
In brief
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.
Key facts
- Study ID
- NCT06726434
- Run by
- Poitiers University Hospital
- People needed
- 114
- Starts
- 2025-07-09
- Expected to finish
- 2029-06-09
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Hôpital Raymond Pointcarré — Garches, France (enrolling)
- CHRU Montpellier — Montpellier, France (enrolling)
- C.H.U. Poitiers — Poitiers, France (enrolling)
- CHU Rennes — Rennes, France (enrolling)
- Pôle Saint-Hélier — Rennes, France (enrolling)
- CHU Saint-Etienne — Saint-Etienne, France (enrolling)
- Hôpital Purpan — Toulouse, France
Full record on ClinicalTrials.gov
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