Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06726434
NA

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

Sponsor: Poitiers University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-07-09

Completion Date

2029-06-09

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

PROCEDURE

Surgical neurotomy (SN)

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

PROCEDURE

Cryoneurotomy (CN)

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.

Locations (7)

Hôpital Raymond Pointcarré

Garches, France

CHRU Montpellier

Montpellier, France

C.H.U. Poitiers

Poitiers, France

CHU Rennes

Rennes, France

Pôle Saint-Hélier

Rennes, France

CHU Saint-Etienne

Saint-Etienne, France

Hôpital Purpan

Toulouse, France