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Completed

NCT Number: NCT05174702

Assessment of the Ionizing Radiation Received 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Blomet

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irradiation collected at the end of the operation on the active dosimeter

Radiation

Mesure of the irradiation collected at the end of the operation on the active dosimeter for the surgeon, the patient and the operating team

Primary outcomes

  1. Irradiation collected at the end of the operation on the surgeon's active dosimeter

    Time frame: during the time of the surgery

    Measure of irradiation in mSv by a dosimeter

  2. Irradiation collected at the end of the operation on the surgeon's active dosimeter

    Time frame: during the time of the surgery

    Measure of irradiation in mGy.cm² by a dosimeter

Secondary outcomes

  1. Irradiation collected at the end of the operation on the patient's and operating team's

    Time frame: during the time of the surgery

    Measure of irradiation in mSv by a dosimeter

  2. Irradiation collected at the end of the operation on the patient's and operating team's

    Time frame: during the time of the surgery

    Measure of irradiation in mGy.cm² by a dosimeter

  3. Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional

    Time frame: 3 months

    Measure of irradiation in mSv by a dosimeter

  4. Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional

    Time frame: 3 months

    Measure of irradiation in mGy.cm² by a dosimeter

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: RADUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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