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CompletedNCT05174702RADUSUpdated Sep 25, 2023

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

An observational study in Hallux Valgus and Surgery, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Hallux Valgus with a site in France — 3 open to participants now, 5 under way, none of them phase 3. Hallux Valgus · France.

Started
2022
with 2 others
Observational
4 of 17
none open now
Registered
12th of 17
by date
Lead sponsor
3 of 17
GCS Ramsay Santé pour l'Enseignement et la Recherche

Among the 17 studies in Hallux Valgus with a site in France, this one is one of 3 that started in 2022, is one of 4 observational ones, and was the 12th registered.

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

Browse Hallux Valgus studies →

Open to participants now

3 of the 17 studies in Hallux Valgus with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Hallux Valgus with a site in France, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Hallux Valgus
  • Surgery

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant or breastfeeding woman;
  • Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

06

What researchers measure

Primary outcomes

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

    Measure of irradiation in mSv by a dosimeter

    Time frame: during the time of the surgery

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

    Measure of irradiation in mGy.cm² by a dosimeter

    Time frame: during the time of the surgery

Secondary outcomes

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

    Measure of irradiation in mSv by a dosimeter

    Time frame: during the time of the surgery

  2. 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

    Time frame: during the time of the surgery

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

    Measure of irradiation in mSv by a dosimeter

    Time frame: 3 months

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

    Measure of irradiation in mGy.cm² by a dosimeter

    Time frame: 3 months

07

Study locations

1 site
  • Clinique Blomet
    Paris, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Apr 2023, 15 months.

Of 15 observational studies under Hallux Valgus, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 62. This study's 15 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2021
First posted
Jan 3, 2022
StartActual
Jan 5, 2022
Primary completionActual
Apr 12, 2023
CompletionActual
Apr 12, 2023
Last update
Sep 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05174702
Responsible party
Sponsor
First posted
Jan 3, 2022
Start date
Jan 5, 2022
Primary completion
Apr 12, 2023
Completion
Apr 12, 2023
Last update
Sep 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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