Hallux Valgus
Conditions
Keywords
hallux valgus, tourniquet
Brief summary
Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.
Interventions
OTHERtourniquet
peroperation tourniquet
OTHERNo tourniquet
no tourniquet during surgery
Sponsors
Clinique Saint Jean, France
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
The patient will be his or her own control, with one foot operated with a tourniquet and the other without. Once the patient has been included, the surgeon will open the randomization envelope to determine which foot will receive the tourniquet. He will operate on the left foot first.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 who has been informed and has signed the consent form * Patient to be operated on for bilateral hallux valgus with no difference in the procedure performed between the 2 feet, the deformity must not differ by more than 10° (angle M1P1) between the 2 sides. * Surgery planned on the same day for both feet
Exclusion criteria
* Arthritic hallux valgus requiring arthrodesis * Inflammatory pathology (rheumatoid arthritis, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average pain in the first week after surgery | first week after surgery | Comparison between the 2 groups of the average VAS over the first week following surgery, from 0 to 100 points, 0 being the value where the patient has no pain and 100 the maximum pain value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edema | Day 10 after surgery | Measurement of foot edema at D10 during the consultation, taking the difference in cm between the postoperative measurement and the preoperative measurement. |
| Complications | first week after surgery | Occurrence of complications specific to tourniquet use as a percentage in each arm. |
Countries
France
Contacts
CONTACTCecile Spirito
Outcome results
None listed