Tourniquet Use in Hallux Valgus Surgery

NCT ID: NCT06680518

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm with tourniquet

The surgeon will use the tourniquet as usual.

Group Type ACTIVE_COMPARATOR

tourniquet

Intervention Type OTHER

peroperation tourniquet

Arm without tourniquet

The surgeon will operate without the aid of a tourniquet

Group Type EXPERIMENTAL

No tourniquet

Intervention Type OTHER

no tourniquet during surgery

Interventions

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tourniquet

peroperation tourniquet

Intervention Type OTHER

No tourniquet

no tourniquet during surgery

Intervention Type OTHER

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean, France

OTHER

Sponsor Role lead

Responsible Party

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Wayan HEBRARD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique St Jean Sud de France

Saint-Jean-de-Védas, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cecile Spirito

Role: CONTACT

0033467413400

Facility Contacts

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Cecile Spirito

Role: primary

003304 67 01 01 01

Other Identifiers

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2024-A01589-38

Identifier Type: -

Identifier Source: org_study_id

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