MeDe: Carpal tunnel release with added lacertus release vs carpal tunnel release alone
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
Run by Maasstad Hospital · NCT07594821 · Data updated 2026-11-12
In adults with carpal tunnel syndrome, this trial tests whether adding a lacertus fibrosus release to the standard carpal tunnel release helps reduce symptoms and improve hand function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Maasstad Hospital Academic / other |
| Locations | 2 sites (Rotterdam, South Holland and 1 other locations) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07594821 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with CTS confirmed by EMG or nerve ultrasound who are planning surgical treatment and meet eligibility criteria.
✕Probably not a fit
Patients without proximal nerve compression or who respond well to standard carpal tunnel release alone may see no additional benefit from the extended procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two surgical approaches for CTS: releasing only the carpal tunnel versus releasing both the carpal tunnel and the lacertus fibrosus. It targets adults with CTS confirmed by EMG or nerve ultrasound. Outcomes will come from patient-reported symptoms and function after surgery, aiming to see if the extended release provides additional relief for those whose proximal nerve compression may contribute to ongoing symptoms. The study addresses a gap where proximal compression is hard to detect with standard tests, potentially guiding more comprehensive surgical care. Participating centers are Maasstad Hospital in Rotterdam and Spijkenise Medisch Centrum, with adults 18+ who choose surgical treatment and meet eligibility criteria.
Why it matters
Potential benefit: If successful, patients may experience greater symptom relief and fewer residual problems after CTS surgery by addressing proximal nerve compression.
How similar studies have gone: Previous CTS surgeries show substantial residual symptoms in some patients, and there is emerging interest in addressing proximal compression; whether this exact approach will improve outcomes is being tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients being at least 18 years or older * CTS confirmed by EMG or nerve ultrasound * Patient opts for surgical treatment Exclusion Criteria: * 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
Where it's running
-
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands Recruiting -
Spijkenise Medisch Centrum
Rotterdam, South Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Sebastian Poggio Voormolen, BSc, PhD candidate
- Email: PoggioVoormolenS@maasstadziekenhuis.nl
- Phone: +31 6 46560865
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.