ClinicalTrials.gg
Sign In
RecruitingNCT06680518Updated Jun 4, 2026

Tourniquet Use in Hallux Valgus Surgery

An interventional study of tourniquet and No tourniquet in Hallux Valgus, sponsored by Clinique Saint Jean, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Clinique Saint Jean, France · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.

02

Conditions studied

  • Hallux Valgus

Browse trials for

Keywords

  • hallux valgus
  • tourniquet
03

In context

Hallux Valgus

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

This study's planned enrollment of 44 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Clinique Saint Jean, France is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • Arthritic hallux valgus requiring arthrodesis
  • Inflammatory pathology (rheumatoid arthritis, etc.)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Active comparator
    Arm with tourniquet

    The surgeon will use the tourniquet as usual.

    Other: tourniquet

  • Experimental
    Arm without tourniquet

    The surgeon will operate without the aid of a tourniquet

    Other: No tourniquet

Interventions

  • Othertourniquet

    peroperation tourniquet

  • OtherNo tourniquet

    no tourniquet during surgery

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: first week after surgery

Secondary outcomes

  1. Edema

    Measurement of foot edema at D10 during the consultation, taking the difference in cm between the postoperative measurement and the preoperative measurement.

    Time frame: Day 10 after surgery

  2. Complications

    Occurrence of complications specific to tourniquet use as a percentage in each arm.

    Time frame: first week after surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

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

Started Oct 2024 (actual). Primary completion is estimated for Nov 2026, 25 months after the start.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 25 months is close to that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

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

Registered
Nov 5, 2024
First posted
Nov 8, 2024
StartActual
Oct 9, 2024
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Jun 4, 2026
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 Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06680518
Lead sponsor
Clinique Saint Jean, France
Responsible party
Wayan HEBRARD (Doctor, Clinique Saint Jean, France) — Principal investigator
First posted
Nov 8, 2024
Start date
Oct 9, 2024
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 4, 2026

Study contacts

Cecile Spirito
Contact
cecile.spirito@capsante.fr
0033467413400

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hallux Valgus →

Other studies from this sponsor

Clinique Saint Jean, France

Start the discussion