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

NCT05174702 | Completed

• 1 other identifier: 2021-A02408-33
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus; Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  during the time of the surgery

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

  during the time of the surgery

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

  3 months

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

  3 months

Study Arms (2)

Percutaneous surgery

Patient will have a percutaneous hallus valgus surgery

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

conventional surgery

Patient will have a conventional hallus valgus surgery

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

Interventions

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

Percutaneous surgery; conventional surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding woman;
• Patient under guardianship or curatorship, or under a regime of deprivation of liberty.

Sponsors & Collaborators

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

Study Sites (1)

Clinique Blomet

Paris, France

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 3, 2022
• Study Start: January 5, 2022
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)