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

NCT06726434 | Recruiting

• 1 other identifier: CRYOSTROKE
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Stroke; Equinovarus Foot; Refractory Lower Limb Spasticity

Keywords

surgical neurotomy; CryoNeurotomy; spasticity; cryoneurolysis; percutaneous cryoneurolysis

Outcome Measures

Primary Outcomes (1)

• Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity).

  Mean absolute change in spasticity assessed by the Modified Ashworth Scale (MAS) ranging from 0 (no spasticity) to 4 (maximum spasticity). This MAS will be quantified on a passive ankle dorsal flexion with knee extended (180°) movement.

  Between baseline and 90-day follow-up

Secondary Outcomes (19)

• Mean absolute change in functional disability assessed using the Barthel Index (BI).

  Between baseline and 90, 180 and 365-day follow-ups

• Mean absolute change in passive ankle dorsal flexion with knee flexed (90°) and extended (180°) movement spasticity assessed by the Modified Ashworth Scale (MAS)

  Between baseline and 90, 180 and 365-day follow-ups

• Mean absolute change in muscle's response to stretch applied at given velocities assessed by the Tardieu Scale and the Modified Tardieu Scale (MTS)

  Between baseline and 90, 180 and 365-day follow-ups

• Mean absolute change in maximal ankle range of motion (in degrees) assessed with a goniometer in slow and rapid movement

  Between baseline and 90, 180 and 365-day follow-ups

• Mean absolute change in the Medical Research Council (MRC) scale of muscle strength of the impaired foot.

  Between baseline and 90, 180 and 365-day follow-ups

Study Arms (2)

CryoNeurotomy (CN)

EXPERIMENTAL

Cryoneurotomy procedure

Procedure: Cryoneurotomy (CN)

Surgical neurotomy (SN)

ACTIVE COMPARATOR

Surgical neurotomy procedure

Procedure: Surgical neurotomy (SN)

Interventions

Surgical neurotomy (SN) PROCEDURE

Surgical neurotomy will be performed under general anesthesia according to the previous description. Muscle relaxant drugs will not be used in order to prevent any interference with the intraoperative electrical stimulation. The patient will be placed in a prone position and a vertical cutaneous incision will be made at the popliteal fossa location. The tibial nerve will be dissected and the motor nerve branches of the soleus, gastrocnemius, tibialis posterior and flexor hallucis longus will be identified with intraoperative tripolar electrical stimulation. The selected motor nerve branches will be partially sectioned over a 5mm length under the microscope. The extent of nerve section will be determined according to the degree of spasticity and to the intraoperative residual muscular contraction under electrical stimulation

Surgical neurotomy (SN)

Cryoneurotomy (CN) PROCEDURE

After the use of an aseptic technique with 2% chlorhexidine, betadine application and a local anesthesia with lidocaine 1% (3ml), percutaneous cryoneurotomy will be performed with METRUM CRYOFLEX device guided by ultrasound with 1.2mm cryoprobe at -89°C placed through a #16 angio guide. Electrical stimulation will be performed to confirm tibial nerve contact at 0.8 mV. The ice ball will be repositioned to two spots along the nerve. Each lesion will be treated for 2min cryoneurolysis at -89°C, followed by 2min without freezing (passive defreezing period) and 2min of cryoneurolysis at -89°C, based on cryotherapy for pain management.

CryoNeurotomy (CN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (7)

Hôpital Raymond Pointcarré

Garches, 92380, France

RECRUITING

CHRU Montpellier

Montpellier, 34295, France

RECRUITING

C.H.U. Poitiers

Poitiers, 86000, France

RECRUITING

CHU Rennes

Rennes, 35000, France

RECRUITING

Pôle Saint-Hélier

Rennes, 35000, France

RECRUITING

CHU Saint-Etienne

Saint-Etienne, 44055, France

RECRUITING

Hôpital Purpan

Toulouse, 31059, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Romain DAVID, MD

CONTACT

+33 5 49 44 44 54; romain.david@chu-poitiers.fr

Corinne LORRAIN

CONTACT

+33 5 49 44 39 30; corinne.lorrain@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 10, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): April 9, 2029
• Study Completion (Estimated): June 9, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)