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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\>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.

Locations
Other Locations
France
Hôpital Raymond Pointcarré
RECRUITING
Garches
CHRU Montpellier
RECRUITING
Montpellier
C.H.U. Poitiers
RECRUITING
Poitiers
CHU Rennes
RECRUITING
Rennes
Pôle Saint-Hélier
RECRUITING
Rennes
CHU Saint-Etienne
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