Tourniquet versus dual-flow arthroscopy sheath for ACL reconstruction
A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other |
| Locations | 2 sites (Hyères, Var and 1 other locations) |
| Trial ID | NCT06819696 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hyères, Var and 1 other locations
- Centre Hospitalier de Hyères — Hyères, Var, France (Recruiting)
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer — Toulon, Var, France (Recruiting)
Study contacts
- Study coordinator: Magali CESANA
- Email: magali.cesana@ch-toulon.fr
- Phone: 04 83 77 20 60
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.