Tourniquet versus dual-flow arthroscopy sheath for ACL reconstruction
Official title: A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.
Run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · NCT06819696 · Data updated 2026-11-12
This trial will test whether using a dual-flow arthroscopy sheath instead of a thigh tourniquet during ACL reconstruction reduces postoperative pain and complications in adults having primary ACL surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other |
| Locations | 3 sites (Reims, Marne and 2 other locations) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | November 2027 |
| Study ends | April 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT06819696 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older undergoing primary ACL reconstruction who can give informed consent and are covered by a social security regimen are ideal candidates.
✕Probably not a fit
Patients undergoing revision or multi-ligament ACL surgery, those with meniscal or chondral injuries preventing immediate weight-bearing, people with bleeding disorders, pregnant or breastfeeding women, or those under legal guardianship are unlikely to be eligible or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized comparison of standard thigh tourniquet use versus a dual-flow arthroscopy sheath in adults undergoing primary arthroscopic ACL reconstruction. Patients are randomized to receive ACL reconstruction with either a tourniquet or the dual-flow sheath, with baseline assessments before surgery and follow-up visits at 7 days, 21 days, 45 days, and 5 months postoperatively. Outcomes will include intraoperative visibility and procedure time as well as postoperative pain, bleeding, muscle injury, and thromboembolic events. The trial is conducted at two regional hospitals in Var, France.
Why it matters
Potential benefit: If successful, replacing the tourniquet with a dual-flow sheath could reduce postoperative pain and lower the risk of tourniquet-related complications while preserving surgical visibility.
How similar studies have gone: Prior studies have linked tourniquet use to increased pain and complications, but randomized evidence specifically supporting dual-flow arthroscopy sheaths as a tourniquet alternative is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary ACL reconstruction * Age 18 years or older * Provided informed consent prior to study participation * Affiliated to or beneficiary of a social security regimen Exclusion Criteria: * Multi-ligamentous surgery * Revision ACL surgery * Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively * Bleeding disorder * Pregnant, parturient or breastfeeding women * Patient under legal guardianship * Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the objectives of the study objectives
Where it's running
-
Centre Hospitalier de Hyères
Hyères, Var, France Recruiting -
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, Var, France Recruiting -
CHU de Reims
Reims, Marne, France Not yet recruiting
Study contacts
- Study coordinator: Magali CESANA
- Email: magali.cesana@ch-toulon.fr
- Phone: 04 83 77 20 60
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.