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

Surgery Clinical Trial

— RADUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174702
• Other study ID #: 2021-A02408-33
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: September 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus
• Surgery

Intervention

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

Locations

Country	Name	City	State
France	Clinique Blomet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irradiation collected at the end of the operation on the surgeon's active dosimeter	Measure of irradiation in mSv by a dosimeter	during the time of the surgery
Primary	Irradiation collected at the end of the operation on the surgeon's active dosimeter	Measure of irradiation in mGy.cm² by a dosimeter	during the time of the surgery
Secondary	Irradiation collected at the end of the operation on the patient's and operating team's	Measure of irradiation in mSv by a dosimeter	during the time of the surgery
Secondary	Irradiation collected at the end of the operation on the patient's and operating team's	Measure of irradiation in mGy.cm² by a dosimeter	during the time of the surgery
Secondary	Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional	Measure of irradiation in mSv by a dosimeter	3 months
Secondary	Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional	Measure of irradiation in mGy.cm² by a dosimeter	3 months