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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05174702
Acronym
RADUS
Enrollment
71
Registered
2022-01-03
Start date
2022-01-05
Completion date
2023-04-12
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus, Surgery

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.

Interventions

RADIATIONIrradiation 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

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Irradiation collected at the end of the operation on the surgeon's active dosimeterduring the time of the surgeryMeasure of irradiation in mSv by a dosimeter

Secondary

MeasureTime frameDescription
Irradiation collected at the end of the operation on the patient's and operating team'sduring the time of the surgeryMeasure of irradiation in mSv by a dosimeter
Irradiation collected on the passive ring and cornea dosimeters of each health professional3 monthsMeasure of irradiation in mSv by a dosimeter

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026