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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Hallux Valgus
• Intervention / Treatment: Radiation: Irradiation collected at the end of the operation on the active dosimeter

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Clinique Blomet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be managed in accordance with current practice, the choice of surgical strategy for hallus valgus (percutaneous or conventional) being left to the discretion of the investigators.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional	Measure of irradiation in mSv by a dosimeter	3 months
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional	Measure of irradiation in mGy.cm² by a dosimeter	3 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: 2021-A02408-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No