Tourniquet Use in Hallux Valgus Surgery
ConditionHallux Valgus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint Jean, France
About this trial
Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Arthritic hallux valgus requiring arthrodesis
Inflammatory pathology (rheumatoid arthritis, etc.)
Trial design
Design model
Crossover
Treatments tested in this trial
tourniquet
Other interventionperoperation tourniquet
No tourniquet
Other interventionno tourniquet during surgery
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Arm with tourniquetActive comparator 1 intervention
Group B: Arm without tourniquetExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Average pain in the 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.
Time frame
first week after surgerySecondary outcomes
1
Edema
Measurement of foot edema at D10 during the consultation, taking the difference in cm between the postoperative measurement and the preoperative measurement.
Time frame
Day 10 after surgery2
Complications
Occurrence of complications specific to tourniquet use as a percentage in each arm.
Time frame
first week after surgerySponsors and contacts
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Source ClinicalTrials.gov