Actively Recruiting
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
Led by Poitiers University Hospital · Updated on 2026-02-25
114
Participants Needed
7
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic spastic equinovarus foot due to stroke (more than 6 months since stroke)
- Positive perineural motor block test with or without complete correction of spastic equinus and no persistence of 40° equinus
- Eligible for surgical neurotomy for varus equinus foot
- No cognitive impairment or major depression (Mini Mental State Examination >20, Hospital Anxiety and Depression score <11)
- No active psychosis or history of serious psychotic illness requiring hospitalization
- Understanding and acceptance of study requirements
- Covered by French national health insurance
- Provided written informed consent after receiving clear information
You will not qualify if you...
- Previous nerve procedures at the same site (chemical neurolysis with alcohol, cryoneurotomy, or surgery)
- Any neurological disorders other than the one causing spasticity
- Botulinum toxin injection in lower limb within 90 days before intervention
- Taking anti-spastic treatment (baclofen) within 3 days before block test
- Complete loss of valgus muscle function
- Equinus foot deformity greater than 40° (due to retractions or ankylosis)
- Contraindications to surgery or anesthesia (severe uncontrolled bleeding disorder, active infection)
- Contraindications to cryoneurotomy (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomenon, recent venous thromboembolism, hypothyroidism, cold urticaria, local blood supply disorders, severe anemia, cachexia, hypothermia, cancer, infection, coagulopathy)
- Subjects requiring special protection (minors, pregnant or nursing women, those deprived of liberty or under legal guardianship, emergency patients)
- Women of childbearing potential not using effective contraception (hormonal, barrier methods, or surgical sterilization)
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hôpital Raymond Pointcarré
Garches, France, 92380
Actively Recruiting
2
CHRU Montpellier
Montpellier, France, 34295
Actively Recruiting
3
C.H.U. Poitiers
Poitiers, France, 86000
Actively Recruiting
4
CHU Rennes
Rennes, France, 35000
Actively Recruiting
5
Pôle Saint-Hélier
Rennes, France, 35000
Actively Recruiting
6
CHU Saint-Etienne
Saint-Etienne, France, 44055
Actively Recruiting
7
Hôpital Purpan
Toulouse, France, 31059
Not Yet Recruiting
Research Team
R
Romain DAVID, MD
CONTACT
C
Corinne LORRAIN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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