Percutaneous cryoneurotomy versus open surgical neurotomy for equinovarus foot after stroke
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
This compares a minimally invasive nerve-freezing procedure (percutaneous cryoneurotomy) with open surgical neurotomy to see if it reduces spastic equinovarus foot in adults with chronic post-stroke lower-limb spasticity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 7 sites (Garches and 6 other locations) |
| Trial ID | NCT06726434 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with chronic (>6 months) post-stroke spastic equinovarus foot who show a positive perineural motor block test, are eligible for surgical neurotomy, have no major cognitive or psychiatric contraindications, and have French national health insurance.
Not a fit: Patients with prior chemical or surgical nerve procedures at the same site, those who do not respond to the motor block test, or those with active neurological disease or significant cognitive/psychiatric impairment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could offer a less invasive option that reduces spastic equinovarus deformity with fewer surgical risks and faster recovery, improving mobility and daily function.
How similar studies have performed: Small case series and nonrandomized reports of cryoneurolysis for focal spasticity and neuropathic pain have shown promising results, but direct head-to-head trials versus surgical neurotomy are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Garches and 6 other locations
- 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)
- Hôpital Purpan — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Romain DAVID, MD
- Email: romain.david@chu-poitiers.fr
- Phone: +33 5 49 44 44 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.