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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Surgical neurotomy (SN)
  • Cryoneurotomy (CN)

Treatment groups

114 Participants
are divided into 2 treatment groups

Sponsors and collaborators