Tourniquet Use in Hallux Valgus Surgery

NCT06680518 | Recruiting

• 1 other identifier: 2024-A01589-38
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hallux Valgus

Keywords

hallux valgus; tourniquet

Outcome Measures

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.

  first week after surgery

Secondary Outcomes (2)

• Edema

  Day 10 after surgery

• Complications

  first week after surgery

Study Arms (2)

Arm with tourniquet

ACTIVE COMPARATOR

The surgeon will use the tourniquet as usual.

Other: tourniquet

Arm without tourniquet

EXPERIMENTAL

The surgeon will operate without the aid of a tourniquet

Other: No tourniquet

Interventions

tourniquet OTHER

peroperation tourniquet

Arm with tourniquet

No tourniquet OTHER

no tourniquet during surgery

Arm without tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Arthritic hallux valgus requiring arthrodesis
• Inflammatory pathology (rheumatoid arthritis, etc.)

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique St Jean Sud de France

Saint-Jean-de-Védas, 34430, France

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Cecile Spirito

CONTACT

0033467413400; cecile.spirito@capsante.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: October 9, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (1)