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

NCT07594821 | Recruiting DMC

• 4 other identifiers: NL-OMON57619NL-005174NL87289.100.2R24.082
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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. 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:

1. 1.Standard surgery - only releasing the carpal tunnel.
2. 2.Extended surgery - releasing both the carpal tunnel and the Lacertus fibrosus.

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.

Outcome Measures

Primary Outcomes (1)

• Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)

  At twelve months follow-up

Secondary Outcomes (12)

• BCTQ FSS

  From enrollment until 12 months of follow-up

• Anchor questions

  At 12 months follow-up

• Residual, persistent en recurrent CTS symptoms

  From 6 weeks after surgery until 12 months of follow-up

• Pillar pain

  From 6 weeks after surgery until 12 months of follow-up

• Secondary surgery

  From 6 weeks until 12 months of follow-up.

Other Outcomes (1)

• Patient Demographics

  At baseline

Study Arms (2)

carpal tunnel release

OTHER

Control group

Procedure: Carpal tunnel release

carpal tunnel release combined with Lacertus release

OTHER

Intervention group

Procedure: Combined carpal tunnel and lacertus release

Interventions

Carpal tunnel release PROCEDURE

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.

carpal tunnel release

Combined carpal tunnel and lacertus release PROCEDURE

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.

carpal tunnel release combined with Lacertus release

Eligibility Criteria

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

You may qualify if:

• Patients being at least 18 years or older
• CTS confirmed by EMG or nerve ultrasound
• Patient opts for surgical treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Maasstad Hospital: lead

Study Sites (2)

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

Spijkenise Medisch Centrum

Rotterdam, South Holland, 3201 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Sebastian Poggio Voormolen, BSc, PhD candidate

CONTACT

+31 6 46560865; PoggioVoormolenS@maasstadziekenhuis.nl

Study Design

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

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

NL (2)