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

Maasstad Hospital

Status

Enrolling

Conditions

Lacertus Syndrome

Carpal Tunnel Syndrome (CTS)

Treatments

Procedure: Carpal tunnel release

Procedure: Combined carpal tunnel and lacertus release

Study type

Interventional

Funder types

Other

Identifiers

NCT07594821

R24.082 (Other Identifier)

NL-OMON57619

NL87289.100.2 (Other Identifier)

NL-005174 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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