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Recruiting

NCT Number: NCT06680518

Tourniquet Use in Hallux Valgus Surgery

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

tourniquet

Other

peroperation tourniquet

No Tourniquet

Other

no tourniquet during surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. Edema

    Time frame: 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.

  2. Complications

    Time frame: first week after surgery

    Occurrence of complications specific to tourniquet use as a percentage in each arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile Spirito

CONTACT

[email protected]

0033467413400

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Official study title

Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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