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

Launched by POITIERS UNIVERSITY HOSPITAL · Dec 5, 2024

Keywords

ClinConnect Summary

The CRYOSTROKE study is a clinical trial that aims to compare two different treatments for patients who have developed a condition called spastic equinovarus foot after having a stroke. This condition causes the foot to point downwards, making it difficult to walk. The trial will look at the effectiveness and safety of a less invasive procedure called percutaneous cryoneurotomy (a technique that uses cold to treat the nerves) compared to a traditional surgical method. The researchers will follow the participants for 90 days after the treatment and then again after 12 months to see how well the treatments work over time.

To be eligible for this study, participants must be 18 years or older, have had a stroke more than six months ago, and have the specific foot condition being studied. They should also not have any major cognitive issues or ongoing severe mental health problems. If you or someone you know is considering participating, you can expect to receive thorough information about the study and will need to give written consent to join. It's important to note that the study is not yet recruiting participants, so there will be some time before it begins.

Gender

ALL

Eligibility 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\>24, Hospital Anxiety and Depression (HAD\<7)).
• • Absence of active psychosis or history of serious psychotic illness requiring hospitalization
• • Patient understanding and accepting the constraints of the study.
• • Free subject, not under temporary or permanent guardianship and not subject to subordination.
• • 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, 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, 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).