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Tourniquet Use in Hallux Valgus Surgery

C

Clinique Saint Jean, France

Status

Enrolling

Conditions

Hallux Valgus

Treatments

Other: No tourniquet
Other: tourniquet

Study type

Interventional

Funder types

Other

Identifiers

NCT06680518
2024-A01589-38

Details and patient eligibility

About

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

Enrollment

44 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Arm with tourniquet
Active Comparator group
Description:
The surgeon will use the tourniquet as usual.
Treatment:
Other: tourniquet
Arm without tourniquet
Experimental group
Description:
The surgeon will operate without the aid of a tourniquet
Treatment:
Other: No tourniquet

Trial contacts and locations

1

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Central trial contact

Cecile Spirito

Data sourced from clinicaltrials.gov

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