RADUS: Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Percutaneous surgery Patient will have a percutaneous hallus valgus surgery |
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
|
| conventional surgery Patient will have a conventional hallus valgus surgery |
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
|
Outcome Measures
Primary Outcome Measures
- Irradiation collected at the end of the operation on the surgeon's active dosimeter [during the time of the surgery]
Measure of irradiation in mSv by a dosimeter
- 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
- 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 mSv by a dosimeter
- 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 mSv 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
Eligibility Criteria
Criteria
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:
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Pregnant or breastfeeding woman;
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Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A02408-33