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

NCT ID: NCT05174702

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-04-12

Brief Summary

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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

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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.

Conditions

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Hallux Valgus Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Percutaneous surgery

Patient will have a percutaneous hallus valgus surgery

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

Intervention Type 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

conventional surgery

Patient will have a conventional hallus valgus surgery

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

Intervention Type 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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Blomet

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2021-A02408-33

Identifier Type: -

Identifier Source: org_study_id

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