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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaasstad Hospital

About this trial

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. Standard surgery - only releasing the carpal tunnel. 2. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients being at least 18 years or older

CTS confirmed by EMG or nerve ultrasound

Patient opts for surgical treatment

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carpal tunnel release

    Procedure/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 release

    Procedure/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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: carpal tunnel releaseOther 1 intervention
Group B: carpal tunnel release combined with Lacertus releaseOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At twelve months follow-up

Secondary outcomes

1

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.

Time frame
From enrollment until 12 months of follow-up
2

Anchor questions

Regarding patient satisfaction to analyse minimal clinically important difference (MCID)

Time frame
At 12 months follow-up
3

Number of participants with residual, persistent en recurrent CTS symptoms

Time frame
From 6 weeks after surgery until 12 months of follow-up
4

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

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

Other outcomes

1

Patient Demographics

Age, sex, labour (blue versus white collar), hand dominance and medical history regarding comorbidities and hand-specific conditions

Time frame
At baseline

Sponsors and contacts

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