Hallux ValgusRADUSNCT05174702
Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus
An observational study of Hallux Valgus and Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Surgery
- What is being tested?
- Irradiation collected at the end of the operation on the active dosimeter
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2022to 12 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding woman;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff 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.
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.
- Conditions
- Hallux Valgus, Surgery
- Being tested
- Irradiation collected at the end of the operation on the active dosimeter
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irradiation collected at the end of the operation on the active dosimeterRadiation
Mesure of the irradiation collected at the end of the operation on the active dosimeter for the surgeon, the patient and the operating team
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous surgery | Patient will have a percutaneous hallus valgus surgery Receives: Radiation: Irradiation collected at the end of the operation on the active dosimeter | |
| conventional surgery | Patient will have a conventional hallus valgus surgery Receives: Radiation: Irradiation collected at the end of the operation on the active dosimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irradiation collected at the end of the operation on the surgeon's active dosimeter
Measure of irradiation in mSv by a dosimeter
Measured: 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
Measured: 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
Measure of irradiation in mSv by a dosimeter
Measured: during the time of the surgery
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
Measured: during the time of the surgery
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional
Measure of irradiation in mSv by a dosimeter
Measured: 3 months
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional
Measure of irradiation in mGy.cm² by a dosimeter
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start5 Jan 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174702
- Sponsor's protocol ID
- 2021-A02408-33
- Acronym
- RADUS
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff During Percutaneous or Conventional Surgery of Hallux Valgus
- ClinicalTrials.gov ID
- NCT05174702
- Acronym / sponsor ID
- RADUS / 2021-A02408-33
- Conditions
- Hallux Valgus, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous surgery | – | Radiation: Irradiation collected at the end of the operation on the active dosimeterPatient will have a percutaneous hallus valgus surgery |
| conventional surgery | – | Radiation: Irradiation collected at the end of the operation on the active dosimeterPatient will have a conventional hallus valgus surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irradiation collected at the end of the operation on the active dosimeterMesure of the irradiation collected at the end of the operation on the active dosimeter for the surgeon, the patient and the operating team | Radiation | Percutaneous surgery, conventional surgery |
Primary outcome
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
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
4 secondary outcomes
Irradiation collected at the end of the operation on the patient's and operating team's
Time frame: during the time of the surgery
Irradiation collected at the end of the operation on the patient's and operating team's
Time frame: during the time of the surgery
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional
Time frame: 3 months
Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus and Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irradiation collected at the end of the operation on the surgeon's active dosimeter (time frame: during the time of the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.