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

NCT06678646 | Not Yet Recruiting

• 1 other identifier: 2024-A01191-46
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Median Nerve Entrapment

Outcome Measures

Primary Outcomes (1)

• Disability and symptoms related to damage of the upper limb

  Disability and symptoms will be assessed with Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire (0 - 100 points). 0 means normal limb whereas 100 means full disability.

  Day 30

Secondary Outcomes (7)

• Clamping force

  Day 30 and Month 6

• Clamping force

  Day 30 and month 6

• Upper limb pain

  Day1, Day 30 and month 6

• Persistent numbness

  Day1, Day 30 and month 6

• Patient satisfaction

  Day 30 and month 6

Study Arms (1)

Ultrasound guided surgery

EXPERIMENTAL

Percutaneous Ultrasound-Guided Release of the Lacertus Fibrosus for Median Nerve Entrapment at the Elbow

Procedure: Elbow ultrasound-guided surgery

Interventions

Elbow ultrasound-guided surgery PROCEDURE

Percutaneous Ultrasound-Guided Release of the Lacertus Fibrosus for Median Nerve Entrapment at the Elbow

Ultrasound guided surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, aged ≥ 18 years and \< 70 years
• Patient with isolated or bilateral Lacertus syndrome (no associated procedure on the day of surgery).
• Patient with a normal EMG

You may not qualify if:

• Patient with previous elbow surgery
• Patient with a history of elbow fracture
• Patient taking part in another study

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique Les Franciscaines

Versailles, Yvelines, 78000, France

Location

MeSH Terms

Conditions

Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Thomas APARD, MD

  Clinique Les Franciscaines

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas APARD, MD

CONTACT

+ 33 6 81 61 05 80; thomasapard@echo-chirurgie-versailles.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)