Percutaneous cryoneurotomy versus open surgical neurotomy for equinovarus foot after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic spastic equinovarus foot after stroke who respond to a perineural motor block are treated with either percutaneous cryoneurotomy or standard open surgical neurotomy and followed for outcomes. The primary comparison focuses on spasticity and safety measured 90 days after the intervention, with additional follow-up visits extending to 12 months to monitor durability. The protocol excludes patients with prior nerve procedures at the same site or major cognitive/psychiatric impairment and requires French national health insurance coverage. The trial is conducted at multiple French university hospitals including centers in Garches, Montpellier, and Poitiers.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hôpital Raymond Pointcarré
  Garches, France Recruiting
• CHRU Montpellier
  Montpellier, France Recruiting
• C.H.U. Poitiers
  Poitiers, France Recruiting
• CHU Rennes
  Rennes, France Recruiting
• Pôle Saint-Hélier
  Rennes, France Recruiting
• CHU Saint-Etienne
  Saint-Etienne, France Recruiting

Study contacts

• Study coordinator: Romain DAVID, MD
• Email: romain.david@chu-poitiers.fr
• Phone: +33 5 49 44 44 54

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.