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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient with previous elbow surgery

Patient with a history of elbow fracture

Patient taking part in another study

Trial design

Design model

Single group

Treatments tested in this trial

  • Elbow ultrasound-guided surgery

    Procedure/Surgery

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

Treatment groups

107 Participants
are divided into 1 treatment group
Group A: Ultrasound guided surgeryExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Day 30

Secondary outcomes

1

Clamping force

Clamping force will be assessed with "key pinch " test. The pinch meter is placed between the tip of the thumb and the tip of the index finger. Result will be expressed in kilograms. Higher is weight, better is force.

Time frame
Day 30 and Month 6
2

Clamping force

Clamping force will be assessed with Jamar test (grip test using a Jamar® hydraulic hand dynamometer). Result will be expressed in kilograms.Higher is weight, better is force.

Time frame
Day 30 and month 6
3

Upper limb pain

Upper limb pain will be assessed with VAS (Visual Analogic Scale) (0 - 10). 0 means no pain.

Time frame
Day1, Day 30 and month 6
4

Persistent numbness

Numbness will be assessed with VAS (Visual Analogic Scale) (0 - 10). 0 means no numbness whereas 10 means permanent numbness.

Time frame
Day1, Day 30 and month 6

Other outcomes

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