Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus (RADUS)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Completed

Conditions: Hallux Valgus; Surgery

Treatments: Radiation: Irradiation collected at the end of the operation on the active dosimeter

Study type: Observational

Funder types: Other

Identifiers

NCT05174702

2021-A02408-33

Details and patient eligibility

About

To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.

Full description

Prospective, open, comparative, non-randomized, non-interventional, single-center study, focusing on two surgical strategies. Patients will be managed in accordance with current practice, the choice of surgical strategy being left to the discretion of the investigators.

Patients will be informed of the study during a preoperative visit. The data concerning them will be collected on the day of the surgery. No follow-up over time is necessary.

Passive "ring" and "cornea" dosimeters will be worn by healthcare professionals during procedures for patients included in the study. Their data will be collected each month and at the end of the study, and reported secondarily to the number of operations. Several surgeons, dressers and operating assistants will participate in the operations, their data will be aggregated taking into account their function and not individuals.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing percutaneous or conventional hallux valgus surgery;
• Patient capable of understanding the information related to the study, of reading the information leaflet and having expressed his non-opposition to participating in the study.

Exclusion criteria

• Pregnant or breastfeeding woman;
• Patient under guardianship or curatorship, or under a regime of deprivation of liberty.

Trial design

71 participants in 2 patient groups

Percutaneous surgery

Description:

Patient will have a percutaneous hallus valgus surgery

Treatment:

Radiation: Irradiation collected at the end of the operation on the active dosimeter

conventional surgery

Description:

Patient will have a conventional hallus valgus surgery

Treatment:

Radiation: Irradiation collected at the end of the operation on the active dosimeter