Using a tourniquet during surgery for bunions
Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery
This study tests whether using a tourniquet during bunion surgery helps patients recover better compared to surgery without one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Saint Jean, France Academic / other |
| Locations | 1 site (Saint-Jean-de-Védas) |
| Trial ID | NCT06680518 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of using a tourniquet during hallux valgus surgery, specifically bunion surgery. It is a prospective, single-center, randomized interventional trial where patients will serve as their own controls, allowing for a direct comparison of outcomes between surgeries performed with and without a tourniquet. The study aims to evaluate the impact of tourniquet use on surgical outcomes and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for bilateral hallux valgus surgery with similar deformities on both feet.
Not a fit: Patients with arthritic hallux valgus or inflammatory conditions like rheumatoid arthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery times for patients undergoing bunion surgery.
How similar studies have performed: While the use of tourniquets in various surgical procedures has been studied, this specific approach in hallux valgus surgery is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Arthritic hallux valgus requiring arthrodesis * Inflammatory pathology (rheumatoid arthritis, etc.)
Where this trial is running
Saint-Jean-de-Védas
- Clinique St Jean Sud de France — Saint-Jean-de-Védas, France (Recruiting)
Study contacts
- Study coordinator: Cecile Spirito
- Email: cecile.spirito@capsante.fr
- Phone: 0033467413400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.