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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Raymond Pointcarré
RECRUITING
Garches
CHRU Montpellier
NOT_YET_RECRUITING
Montpellier
C.H.U. Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Rennes
NOT_YET_RECRUITING
Rennes
Pôle Saint-Hélier
NOT_YET_RECRUITING
Rennes
CHU Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
Hôpital Purpan
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Romain DAVID, MD
romain.david@chu-poitiers.fr
+33 5 49 44 44 54
Backup
Corinne LORRAIN
corinne.lorrain@chu-poitiers.fr
+33 5 49 44 39 30
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2029-06-09
Participants
Target number of participants: 114
Treatments
Experimental: CryoNeurotomy (CN)
Cryoneurotomy procedure
Active_comparator: Surgical neurotomy (SN)
Surgical neurotomy procedure
Related Therapeutic Areas
Sponsors
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov