Median Nerve EntrapmentLACECHOCHIRNCT06678646
Ultrasound-guided Release of the Median Nerve at the Elbow in Patients With Lacertus Syndrome
A study testing Elbow ultrasound-guided surgery in people with Median Nerve Entrapment, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Median Nerve Entrapment
- What is being tested?
- Elbow ultrasound-guided surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with previous elbow surgery
- Patient with a history of elbow fracture
- Patient taking part in another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Les Franciscaines
Versailles, Yvelines, 78000
Thomas APARD, MD, + 33 6 81 61 05 80, thomasapard@echo-chirurgie-versailles.fr
About this study
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.
Read more
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.
Read the detailed description
The lacertus fibrosus is a thick, tough, fibrous band of connective tissue. The lacertus fibrosus is a continuation of the tendon of the biceps brachii muscle. It plays a role in protecting the median nerve, which passes under this ligament as it travels towards the hand.
Lacertus syndrome is an orthopaedic condition that occurs when the median nerve is compressed where it passes under the lacertus fibrosus. This syndrome can affect both men and women, generally after the age of 35. It can occur on one side or bilaterally. Common symptoms vary from person to person and include pain in the forearm, elbow and sometimes the shoulder, a feeling of tiredness or heaviness in the forearm, muscle weakness in the thumb and grip, clumsiness, loss of stamina and variable tingling in the first three fingers of the hand (thumb, index and middle fingers), similar to carpal tunnel syndrome.
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. They may include physiotherapy, non-steroidal anti-inflammatory drugs (NSAIDs), orthoses, corticosteroid injections and surgery.
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 new ultrasound-guided surgical technique reduces the side-effects associated with surgery (infection, algodystrophy, scarring), limits the need for time off work and reduces overall costs.
This new ultrasound-guided surgical technique was tested on a series of 18 cadavers and then on a series of 15 patients for whom a lacertus syndrome had been diagnosed. 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
- Being tested
- Elbow ultrasound-guided surgery
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow ultrasound-guided surgeryProcedure or surgery
Percutaneous Ultrasound-Guided Release of the Lacertus Fibrosus for Median Nerve Entrapment at the Elbow
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided surgery | Experimental | Percutaneous Ultrasound-Guided Release of the Lacertus Fibrosus for Median Nerve Entrapment at the Elbow Receives: Procedure: Elbow ultrasound-guided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (7)
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.
Measured: Day 30 and Month 6
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.
Measured: Day 30 and month 6
Upper limb pain
Upper limb pain will be assessed with VAS (Visual Analogic Scale) (0 - 10). 0 means no pain.
Measured: Day1, Day 30 and month 6
Persistent numbness
Numbness will be assessed with VAS (Visual Analogic Scale) (0 - 10). 0 means no numbness whereas 10 means permanent numbness.
Measured: Day1, Day 30 and month 6
Patient satisfaction
Satisfaction will be assessed with VAS (Visual Analogic Scale) (0 - 10). 0 means totally unsatisfied whereas 10 means totally satisfied.
Measured: Day 30 and month 6
Return to work
Return to work will be assessed with "Return to work" date
Measured: Day 30 and month 6
Return to sport/artistic activities
Return to sport/artistic activities with "Return to sport/artistic activities" date
Measured: Day 30 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start16 Jun 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median Nerve EntrapmentStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas APARD, MD, Principal investigator, Clinique Les Franciscaines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678646
- Sponsor's protocol ID
- 2024-A01191-46
- Acronym
- LACECHOCHIR
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Release of the Median Nerve at the Elbow in Patients With Lacertus Syndrome
- ClinicalTrials.gov ID
- NCT06678646
- Acronym / sponsor ID
- LACECHOCHIR / 2024-A01191-46
- Conditions
- Median Nerve Entrapment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The lacertus fibrosus is a thick, tough, fibrous band of connective tissue. The lacertus fibrosus is a continuation of the tendon of the biceps brachii muscle. It plays a role in protecting the median nerve, which passes under this ligament as it travels towards the hand.
Lacertus syndrome is an orthopaedic condition that occurs when the median nerve is compressed where it passes under the lacertus fibrosus. This syndrome can affect both men and women, generally after the age of 35. It can occur on one side or bilaterally. Common symptoms vary from person to person and include pain in the forearm, elbow and sometimes the shoulder, a feeling of tiredness or heaviness in the forearm, muscle weakness in the thumb and grip, clumsiness, loss of stamina and variable tingling in the first three fingers of the hand (thumb, index and middle fingers), similar to carpal tunnel syndrome.
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. They may include physiotherapy, non-steroidal anti-inflammatory drugs (NSAIDs), orthoses, corticosteroid injections and surgery.
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 new ultrasound-guided surgical technique reduces the side-effects associated with surgery (infection, algodystrophy, scarring), limits the need for time off work and reduces overall costs.
This new ultrasound-guided surgical technique was tested on a series of 18 cadavers and then on a series of 15 patients for whom a lacertus syndrome had been diagnosed. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided surgery | Experimental | Procedure: Elbow ultrasound-guided surgeryPercutaneous Ultrasound-Guided Release of the Lacertus Fibrosus for Median Nerve Entrapment at the Elbow |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient with previous elbow surgery
- Patient with a history of elbow fracture
- Patient taking part in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbow ultrasound-guided surgeryPercutaneous Ultrasound-Guided Release of the Lacertus Fibrosus for Median Nerve Entrapment at the Elbow | Procedure or surgery | Ultrasound guided surgery |
Primary outcome
Disability and symptoms related to damage of the upper limb
Time frame: Day 30
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.
7 secondary outcomes
Clamping force
Time frame: Day 30 and Month 6
Clamping force
Time frame: Day 30 and month 6
Upper limb pain
Time frame: Day1, Day 30 and month 6
Persistent numbness
Time frame: Day1, Day 30 and month 6
Patient satisfaction
Time frame: Day 30 and month 6
Return to work
Time frame: Day 30 and month 6
Return to sport/artistic activities
Time frame: Day 30 and month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas APARD, MD principal investigator
Clinique Les Franciscaines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow ultrasound-guided surgery in people with Median Nerve Entrapment, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas APARD, MD (+ 33 6 81 61 05 80, thomasapard@echo-chirurgie-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability and symptoms related to damage of the upper limb (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.