Hallux ValgusNCT06680518
Tourniquet Use in Hallux Valgus Surgery
A study testing tourniquet and No tourniquet in people with Hallux Valgus, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- tourniquet and No tourniquet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients over 18 who has been informed and has signed the consent form
- Patient to be operated on for bilateral hallux valgus with no difference in the procedure performed between the 2 feet, the deformity must not differ by more than 10° (angle M1P1) between the 2 sides.
- Surgery planned on the same day for both feet
Who cannot join
- Arthritic hallux valgus requiring arthrodesis
- Inflammatory pathology (rheumatoid arthritis, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique St Jean Sud de France
Saint-Jean-de-Védas, 34430
Cecile Spirito, 003304 67 01 01 01, cecile.spirito@capsante.fr
About this study
Official title: Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery
Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.
- Conditions
- Hallux Valgus
- Being tested
- tourniquet, No tourniquet
- Keywords
- hallux valgus, tourniquet
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquetOther
peroperation tourniquet
No tourniquetOther
no tourniquet during surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm with tourniquet | Active comparator | The surgeon will use the tourniquet as usual. Receives: Other: tourniquet |
| Arm without tourniquet | Experimental | The surgeon will operate without the aid of a tourniquet Receives: Other: No tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain in the first week after surgery
Comparison between the 2 groups of the average VAS over the first week following surgery, from 0 to 100 points, 0 being the value where the patient has no pain and 100 the maximum pain value.
Measured: first week after surgery
Secondary outcomes (2)
Edema
Measurement of foot edema at D10 during the consultation, taking the difference in cm between the postoperative measurement and the preoperative measurement.
Measured: Day 10 after surgery
Complications
Occurrence of complications specific to tourniquet use as a percentage in each arm.
Measured: first week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start9 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patient will be his or her own control, with one foot operated with a tourniquet and the other without. Once the patient has been included, the surgeon will open the randomization envelope to determine which foot will receive the tourniquet. He will operate on the left foot first.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayan HEBRARD, Clinique Saint Jean, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680518
- Sponsor's protocol ID
- 2024-A01589-38
- Status last verified
- Jun 2026
- First submitted
- 5 Nov 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT06680518
- Acronym / sponsor ID
- 2024-A01589-38
- Conditions
- Hallux Valgus
- Keywords
- hallux valgus, tourniquet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Nov 2024 (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.
Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patient will be his or her own control, with one foot operated with a tourniquet and the other without. Once the patient has been included, the surgeon will open the randomization envelope to determine which foot will receive the tourniquet. He will operate on the left foot first.
| Arm | Type | Receives |
|---|---|---|
| Arm with tourniquet | Active comparator | Other: tourniquetThe surgeon will use the tourniquet as usual. |
| Arm without tourniquet | Experimental | Other: No tourniquetThe surgeon will operate without the aid of a tourniquet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 who has been informed and has signed the consent form
- Patient to be operated on for bilateral hallux valgus with no difference in the procedure performed between the 2 feet, the deformity must not differ by more than 10° (angle M1P1) between the 2 sides.
- Surgery planned on the same day for both feet
Key exclusion criteria (2 listed)
- Arthritic hallux valgus requiring arthrodesis
- Inflammatory pathology (rheumatoid arthritis, etc.)
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 |
|---|---|---|
| tourniquetperoperation tourniquet | Other | Arm with tourniquet |
| No tourniquetno tourniquet during surgery | Other | Arm without tourniquet |
Primary outcome
Average pain in the first week after surgery
Time frame: first week after surgery
Comparison between the 2 groups of the average VAS over the first week following surgery, from 0 to 100 points, 0 being the value where the patient has no pain and 100 the maximum pain value.
2 secondary outcomes
Edema
Time frame: Day 10 after surgery
Complications
Time frame: first week after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hallux Valgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tourniquet and No tourniquet in people with Hallux Valgus, run by Clinique Saint Jean, France 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 3 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecile Spirito (0033467413400, cecile.spirito@capsante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain in the first week after surgery (time frame: first week after surgery). 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 4 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.