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

Completed

• Conditions: Hallux Valgus; Surgery
• Interventions: Radiation: Irradiation collected at the end of the operation on the active dosimeter

• Registration Number: NCT05174702
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2022-01-03
• Study Start: 2022-01-05
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous surgery	Irradiation collected at the end of the operation on the active dosimeter	Patient will have a percutaneous hallus valgus surgery
conventional surgery	Irradiation collected at the end of the operation on the active dosimeter	Patient will have a conventional hallus valgus surgery

Primary Outcome Measures

Name	Time	Method
Irradiation collected at the end of the operation on the surgeon's active dosimeter	during the time of the surgery	Measure of irradiation in mGy.cm² by a dosimeter

Secondary Outcome Measures

Name	Time	Method
Irradiation collected at the end of the operation on the patient's and operating team's	during the time of the surgery	Measure of irradiation in mGy.cm² by a dosimeter
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional	3 months	Measure of irradiation in mGy.cm² by a dosimeter

Trial Locations

Locations (1)

Clinique Blomet; 🇫🇷 Paris, France