NCT06726434Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 9 Jul 2025
- Primary completion date
- 9 Apr 2029
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Stroke
- NCT number
- NCT06726434
What you commit to
- Study type: Interventional
- Planned participants: 114
- From 9 Jul 2025 to the primary completion date, 9 Apr 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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…).).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Raymond Pointcarré Coordinator of this site? Confirm its status | Garches | France | Recruiting |
| CHRU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| C.H.U. Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Pôle Saint Hélier Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
| Hopital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.