Orthopedic Equine Varus Deformity Clinical Trial
— talobotOfficial title:
Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study
| NCT number | NCT02790346 |
| Other study ID # | 9547 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2015 |
| Est. completion date | June 27, 2023 |
| Verified date | March 2024 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | June 27, 2023 |
| Est. primary completion date | June 27, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 74 Years |
| Eligibility | Inclusion Criteria: - Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months - Orthopedic equine-varus deformity of the foot and ankle requiring surgery - Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability Exclusion Criteria: - History of foot surgery the side to be operated - Significant deformation set foot and ankle (requiring treatment with triple arthrodesis) - Bilateral surgery - Progressive neurological disease - Dystonic movements or movement disorders - Realization of a botulinum toxin injection in the 6 months preceding gesture - Important cognitive impairment |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Lapeyronie | Montpellier | Herault |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | walking speed at one year | 12 months after surgery intervention | ||
| Secondary | walking speed at 3 and 6 months | 3 months and 6 months after surgery intervention |