Carpal Tunnel Syndrome (CTS)MeDeNCT07594821
MeDe Study: Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome
A study testing Carpal tunnel release and Combined carpal tunnel and lacertus release in people with Carpal Tunnel Syndrome (CTS) and Lacertus Syndrome, run by Maasstad Hospital at 2 sites in Netherlands.
Trial summary
Carpal tunnel syndrome (CTS) is a condition that can cause pain, numbness, or tingling in the hand and wrist. The most common surgery for CTS is called carpal tunnel release, which aims to relieve pressure on the main nerve in the wrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Lacertus Syndrome
- What is being tested?
- Carpal tunnel release and Combined carpal tunnel and lacertus release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesNetherlands
- Study dates
- 6 May 2026to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being at least 18 years or older
- CTS confirmed by EMG or nerve ultrasound
- Patient opts for surgical treatment
Who cannot join
- Previous surgical decompression of the median nerve at the ipsilateral wrist or forearm
- Severe thenar atrophy: Examination of the thenar is based on clinical observation. The presence of thenar muscle atrophy is scored as none, mild, or severe.
- Simultaneous nerve decompression in the ipsilateral arm (e.g. cubital tunnel, Guyon and radial nerve release.
- Neurological disorders affecting peripheral nerves (e.g. spinal cord compression or injury, muscular dystrophy, dystonia, ALS)
- Malunion of the distal radius
- Impaired hand function
- Pregnancy
- Inability to complete study forms due to insufficient comprehension of the Dutch language
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian Poggio Voormolen, BSc, PhD candidate contact
Netherlands2 sites, 2 recruiting
- Recruiting
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ
Niels W.L Schep, MD, PhD, +31 6 24232542, SchepN@maasstadziekenhuis.nl
Sebastian Poggio Voormolen, BSc, PhD candidate
- Recruiting
Spijkenise Medisch Centrum
Rotterdam, South Holland, 3201 GZ
Niels W.L Schep, MD, PhD, +31 6 24232542, SchepN@maasstadziekenhuis.nl
Sebastian Poggio Voormolen, BSc, PhD candidate
About this study
Official title: MeDe Study: A Randomized Controlled Trial Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is a condition that can cause pain, numbness, or tingling in the hand and wrist. The most common surgery for CTS is called carpal tunnel release, which aims to relieve pressure on the main nerve in the wrist.
However, after this surgery, some patients (up to 4 out of 10) still have symptoms, and about 1 in 8 may need another surgery. One reason symptoms can continue is that the nerve may also be compressed higher up in the arm, near a ligament called the Lacertus fibrosus. Releasing this area might help, but it is often not checked or treated during the first surgery because current tests (like physical exams, nerve studies, and ultrasounds) cannot reliably detect it.
Read more
This study is comparing two approaches for people with CTS:
- Standard surgery - only releasing the carpal tunnel.
- Extended surgery - releasing both the carpal tunnel and the Lacertus fibrosus.
The goal is to see which surgery helps patients feel better and have fewer symptoms in the hand and wrist after treatment.
Read the detailed description
Carpal tunnel release is the most commonly performed surgical procedure in patients diagnosed with carpal tunnel syndrome (CTS). Nevertheless, up to 43% of patients experience residual symptoms, necessitating secondary surgical interventions in approximately one out of eight carpal tunnel releases.
These residual symptoms may be attributable to proximal median nerve compression (PMNC), which can potentially be alleviated by performing a Lacertus release. However, diagnosing PMNC poses a challenge, as standard diagnostic tools like physical examination, electromyography (EMG) and ultrasound lack the specificity to distinguish between CTS and PMNC. Consequently, PMNC often goes undetected and untreated during initial evaluations.
This randomised trial compares patient reported outcomes following median nerve decompression at the carpal tunnel alone versus median nerve decompression at both the carpal tunnel and the Lacertus fibrosus in individuals with CTS.
- Conditions
- Carpal Tunnel Syndrome (CTS), Lacertus Syndrome
- Being tested
- Carpal tunnel release, Combined carpal tunnel and lacertus release
- Keywords
- carpal tunnel syndrome, proximal median nerve compression, lacertus syndrome, double crush, nerve decompression, carpal tunnel release, lacertus release.
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal tunnel releaseProcedure or surgery
Carpal tunnel release is a surgical procedure to treat carpal tunnel syndrome by cutting the ligament (transverse carpal ligament) covering the wrist's carpal tunnel. This action relieves pressure on the median nerve, alleviating pain, numbness, and weakness in the hand. It is usually an outpatient procedure done under local anesthesia.
Combined carpal tunnel and lacertus releaseProcedure or surgery
A transverse incision is made on the forearm's volar (anterior) aspect, approximately 3cm distal of the elbow crease. This incision is placed over the palpable brachioradialis and biceps tendon. The subcutaneous tissue is dissected to expose the fascia overlying the flexor pronator muscles. The brachial fascia is identified and incised to reveal the underlying Lacertus fibrosus (also known as the bicipital aponeurosis). The Lacertus fibrosus is a tendinous band extending from the biceps tendon medially across the forearm. Care is taken to avoid injury to the underlying structures, particularly the median nerve, which lies deep and slightly medial to the Lacertus fibrosus. The Lacertus fibrosus is incised transversely. The surgeon ensures that the median nerve is fully decompressed and that there are no remaining constrictive bands. It is usually an outpatient procedure done under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| carpal tunnel release | Other | Control group Receives: Procedure: Carpal tunnel release |
| carpal tunnel release combined with Lacertus release | Other | Intervention group Receives: Procedure: Combined carpal tunnel and lacertus release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
Measured: At twelve months follow-up
Secondary outcomes (13)
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)
Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
Measured: From enrollment until 12 months of follow-up
Anchor questions
Regarding patient satisfaction to analyse minimal clinically important difference (MCID)
Measured: At 12 months follow-up
Number of participants with residual, persistent en recurrent CTS symptoms
Measured: From 6 weeks after surgery until 12 months of follow-up
Pillar pain
The presence of tenderness or pain in the thenar or hypothenar area around the hook of the hamate and the unciform process of the trapezium
Measured: From 6 weeks after surgery until 12 months of follow-up
Number of participants undergoing secondary surgery
This includes, but is not limited to, nerve decompression, internal or external neurolysis, and flap reconstruction in the ipsilateral arm.
Measured: From 6 weeks until 12 months of follow-up.
Number of participants that experienced complications or adverse events
Such as infection, seroma, and tendon and neurovascular damage.
Measured: From enrollment until 12 months of follow-up.
(Return to) work using the QuickDASH work module.
Measured: From enrollment until 6 months of follow-up.
Sensibility
Monofilament test on the tuft of the 3rd digit and the proximal thenar. The tuft of the 5th digit and the distal thenar will be measured and used as a reference.
Measured: From enrollment until 12 months of follow-up.
Tip-pinch strength
Tip-to-tip pinch strength of the first and second digit will be measured with a baseline pinch gauge.
Measured: From enrollment until 12 months of follow-up
Cost-effectiveness of intervention
Measured with health care resource utilisation and costs (iMCQ, iPCQ).
Measured: From enrollment until 12 months of follow-up
5-level EuroQol (EQ-5D-5L): Quality of life
Will be assessed using the 5-level EuroQol (EQ-5D-5L) questionnaire.
Measured: Will be assessed at baseline and at 12 months of follow-up.
Physical examination
OK-sign, FLP and FDP2 strength separately (compared to contralateral hand). Scratch collapse test over the carpal tunnel and Lacertus fibrosis (positive or negative).
Phalen and Tinel test (positive or negative).
Measured: From enrollment until 12 months of follow-up.
Exploratory ultrasound
Changes in median nerve cross-sectional diameter (mm) to evaluate postoperative changes in nerve size over time, measured by nerve ultrasound.
Measured: Will be assessed at baseline and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start6 May 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594821
- Sponsor's protocol ID
- NL-OMON57619
- Other IDs
- NL-005174, NL87289.100.2, R24.082
- Acronym
- MeDe
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeDe Study: A Randomized Controlled Trial Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07594821
- Acronym / sponsor ID
- MeDe / NL-OMON57619
- Conditions
- Carpal Tunnel Syndrome (CTS), Lacertus Syndrome
- Keywords
- carpal tunnel syndrome, proximal median nerve compression, lacertus syndrome, double crush, nerve decompression, carpal tunnel release, lacertus release.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 May 2026 (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.
Carpal tunnel syndrome (CTS) is a condition that can cause pain, numbness, or tingling in the hand and wrist. The most common surgery for CTS is called carpal tunnel release, which aims to relieve pressure on the main nerve in the wrist.
However, after this surgery, some patients (up to 4 out of 10) still have symptoms, and about 1 in 8 may need another surgery. One reason symptoms can continue is that the nerve may also be compressed higher up in the arm, near a ligament called the Lacertus fibrosus. Releasing this area might help, but it is often not checked or treated during the first surgery because current tests (like physical exams, nerve studies, and ultrasounds) cannot reliably detect it.
This study is comparing two approaches for people with CTS:
- Standard surgery - only releasing the carpal tunnel.
- Extended surgery - releasing both the carpal tunnel and the Lacertus fibrosus.
The goal is to see which surgery helps patients feel better and have fewer symptoms in the hand and wrist after treatment.
Detailed description
Carpal tunnel release is the most commonly performed surgical procedure in patients diagnosed with carpal tunnel syndrome (CTS). Nevertheless, up to 43% of patients experience residual symptoms, necessitating secondary surgical interventions in approximately one out of eight carpal tunnel releases.
These residual symptoms may be attributable to proximal median nerve compression (PMNC), which can potentially be alleviated by performing a Lacertus release. However, diagnosing PMNC poses a challenge, as standard diagnostic tools like physical examination, electromyography (EMG) and ultrasound lack the specificity to distinguish between CTS and PMNC. Consequently, PMNC often goes undetected and untreated during initial evaluations.
This randomised trial compares patient reported outcomes following median nerve decompression at the carpal tunnel alone versus median nerve decompression at both the carpal tunnel and the Lacertus fibrosus in individuals with CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carpal tunnel release | Other | Procedure: Carpal tunnel releaseControl group |
| carpal tunnel release combined with Lacertus release | Other | Procedure: Combined carpal tunnel and lacertus releaseIntervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients being at least 18 years or older
- CTS confirmed by EMG or nerve ultrasound
- Patient opts for surgical treatment
Key exclusion criteria (8 listed)
- Previous surgical decompression of the median nerve at the ipsilateral wrist or forearm
- Severe thenar atrophy: Examination of the thenar is based on clinical observation. The presence of thenar muscle atrophy is scored as none, mild, or severe.
- Simultaneous nerve decompression in the ipsilateral arm (e.g. cubital tunnel, Guyon and radial nerve release.
- Neurological disorders affecting peripheral nerves (e.g. spinal cord compression or injury, muscular dystrophy, dystonia, ALS)
- Malunion of the distal radius
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 |
|---|---|---|
| Carpal tunnel releaseCarpal tunnel release is a surgical procedure to treat carpal tunnel syndrome by cutting the ligament (transverse carpal ligament) covering the wrist's carpal tunnel. This action relieves pressure on the median nerve, alleviating pain, numbness, and weakness in the hand. It is usually an outpatient procedure done under local anesthesia. | Procedure or surgery | carpal tunnel release |
| Combined carpal tunnel and lacertus releaseA transverse incision is made on the forearm's volar (anterior) aspect, approximately 3cm distal of the elbow crease. This incision is placed over the palpable brachioradialis and biceps tendon. The subcutaneous tissue is dissected to expose the fascia overlying the flexor pronator muscles. The brachial fascia is identified and incised to reveal the underlying Lacertus fibrosus (also known as the bicipital aponeurosis). The Lacertus fibrosus is a tendinous band extending from the biceps tendon medially across the forearm. Care is taken to avoid injury to the underlying structures, particularly the median nerve, which lies deep and slightly medial to the Lacertus fibrosus. The Lacertus fibrosus is incised transversely. The surgeon ensures that the median nerve is fully decompressed and that there are no remaining constrictive bands. It is usually an outpatient procedure done under local anesthesia. | Procedure or surgery | carpal tunnel release combined with Lacertus release |
Primary outcome
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Time frame: At twelve months follow-up
Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
13 secondary outcomes
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)
Time frame: From enrollment until 12 months of follow-up
Anchor questions
Time frame: At 12 months follow-up
Number of participants with residual, persistent en recurrent CTS symptoms
Time frame: From 6 weeks after surgery until 12 months of follow-up
Pillar pain
Time frame: From 6 weeks after surgery until 12 months of follow-up
Number of participants undergoing secondary surgery
Time frame: From 6 weeks until 12 months of follow-up.
Number of participants that experienced complications or adverse events
Time frame: From enrollment until 12 months of follow-up.
(Return to) work using the QuickDASH work module.
Time frame: From enrollment until 6 months of follow-up.
Sensibility
Time frame: From enrollment until 12 months of follow-up.
Tip-pinch strength
Time frame: From enrollment until 12 months of follow-up
Cost-effectiveness of intervention
Time frame: From enrollment until 12 months of follow-up
5-level EuroQol (EQ-5D-5L): Quality of life
Time frame: Will be assessed at baseline and at 12 months of follow-up.
Physical examination
Time frame: From enrollment until 12 months of follow-up.
Exploratory ultrasound
Time frame: Will be assessed at baseline and 3 months.
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 26 Jun 2026.
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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.
Sebastian Poggio Voormolen, BSc, PhD candidate contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal tunnel release and Combined carpal tunnel and lacertus release in people with Carpal Tunnel Syndrome (CTS) and Lacertus Syndrome, run by Maasstad Hospital at 2 sites in Netherlands.
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 8 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Sebastian Poggio Voormolen, BSc, PhD candidate (+31 6 46560865, PoggioVoormolenS@maasstadziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) (time frame: At twelve months follow-up). 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 26 Jun 2026.