Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery

Clinique Saint Jean, France1 site in 1 country44 target enrollmentOctober 9, 2024

ConditionsHallux Valgus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hallux Valgus
Sponsor: Clinique Saint Jean, France
Enrollment: 44
Locations: 1
Primary Endpoint: Average pain in the first week after surgery
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.

Registry

clinicaltrials.gov

Start Date

October 9, 2024

End Date

April 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Clinique Saint Jean, France

Responsible Party

Principal Investigator

Wayan HEBRARD

Doctor

Clinique Saint Jean, France

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Average pain in the first week after surgery

Time Frame: 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.