NCT05174702

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

Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff During Percutaneous or Conventional Surgery of Hallux Valgus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hallux Valgus
• Surgery

Interventions

Type	Name	Description
RADIATION	Irradiation collected at the end of the operation on the active dosimeter	Mesure of the irradiation collected at the end of the operation on the active dosimeter for the surgeon, the patient and the operating team

Timeline

• Start date: 2022-01-05
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2022-01-03
• Last updated: 2023-09-25

Locations

1 site across 1 country: France