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Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction

Study acronym: RELICA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv11
  2. Notable Primary completion pushed from Oct 2026 to Nov 2027
    • Study completion pushed from Mar 2027 to Apr 2028
    • Study sites: 2 to 3
    v10
  3. Minor 4 versions Re-verified since Nov 19, 2025, no change to tracked fieldsv6-v9
  4. Minor Site details revised at 1 of 2 sitesv5
  5. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Sep 2026 to Oct 2026
    • Study completion date: Feb 2027 to Mar 2027
    • Start date changed from estimate of Apr 2025 to May 12, 2025
    • Site details revised at 2 of 2 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Primary completion date: Aug 2026 to Sep 2026
    • Study completion date: Jan 2027 to Feb 2027
    • Start date: Mar 2025 to Apr 2025
    v3
  2. Minor Primary completion date: Jul 2026 to Aug 2026
    • Study completion date: Dec 2026 to Jan 2027
    • Start date: Feb 2025 to Mar 2025
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective randomized study comparing tourniquet use versus a dual-flow arthroscopy sheath in Anterior Cruciate Ligament (ACL) reconstruction surgery. The ACL is largely responsible for knee stability and contributes to central pivot with the posterior cruciate ligament. ACL rupture is associated with a violent twisting motion of the knee, which is usually irreparable without surgical intervention. ACL reconstruction via arthroscopy is the gold standard treatment for young, active patients with knee instability. Reconstruction is commonly performed using a thigh tourniquet to improve intraoperative visibility, reduce bleeding, and shorten procedure time. However, numerous studies associate tourniquet use with an increased risk of postoperative complications such as increased pain, muscle injury, postoperative bleeding, and deep vein thrombosis. Therefore, it seems relevant to conduct further investigations into the benefits of new methods to replace tourniquet. In this context, the dual-flow arthroscopy sheath could improve postoperative recovery after ACL reconstruction and could limit the risk of complications, thus improving ambulatory care for patients. This study propose to compare two groups of patients undergoing ACL reconstruction: those operated on with a tourniquet versus those operated on using the dual-flow arthroscopy sheath.
Trial Details
NCT Number NCT06819696
Lead Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Conditions
(from sponsor)
Anterior Cruciate Ligament Reconstruction
Related terms Pain
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov