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Ultrasound-guided Release of the Median Nerve at the Elbow in Patients With Lacertus Syndrome

Study acronym: LACECHOCHIR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Dec 31, 2026 → Aug 31, 2028
See other at-risk trials from GCS Ramsay Santé pour l'Enseignement et la Recherche

Record History

  1. Notable Primary and study completion pushed from Dec 31, 2026 to Aug 31, 2028
    • Recruitment opened
    • Start date changed from estimate of Dec 1, 2025 to Jun 16, 2025
    • Site details revised
    v3
  2. Notable Start date: Dec 1, 2024 to Dec 1, 2025v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Lacertus syndrome is an orthopaedic condition that occurs when the median nerve is compressed where it passes under the lacertus fibrosus. Treatment for lacertus syndrome is generally aimed at relieving compression of the median nerve and reducing associated symptoms. Treatment options vary according to the severity of the condition and the patient's individual needs. Sectioning the Lacertus fibrosus frees the median nerve. It is performed as an outpatient procedure under local anaesthetic, and the patient can resume his or her activities immediately. Lacertus fibrosus section has been described as an open procedure, i.e. with a horizontal scar in the elbow crease. Ultrasound guided surgery is an innovative technique that has proved its effectiveness for nerve releases such as the median nerve in the carpal tunnel or the ulnar nerve in the elbow. This technique was tested on a series of 18 cadavers and then on a series of 15 patients with a lacertus syndrome. The patients underwent the operation without any immediate surgical or anaesthetic complications. Muscle strength returned immediately and persisted. Pain was reduced and all patients who were working were able to carry out their professional activities from the very first week. The millimetric skin incision healed without hypertrophic scar tissue. A small haematoma appeared at week 1 and resolved spontaneously. No other late complications were observed. In this context, this study would consolidate the preliminary results observed and confirm the hypothesis that minimally invasive percutaneous surgery under ultrasound is appropriate for sectioning Lacertus fibrosus safely, rapidly and effectively in Lacertus syndrome.
Trial Details
NCT Number NCT06678646
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions
(from sponsor)
Median Nerve Entrapment
Related terms Median Neuropathy
Enrollment 107 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov