Median Nerve Compression Nerve compression in the arm
Conditions
Interventions
The intervention group will receive a carpal tunnel release supplemented with a 
Lacertus release. This combination of carpal tunnel and Lacertus release is the 
standard treatment for median nerve double crush syndrome. The control group 
receives the standard treatment consisting of a carpal tunnel release. 
Lacertus Release Surgical Procedure
Local or regional anaesthesia is administered. The patient is positioned supine 
with the arm extended on an arm board. The surgical site is sterilised, and a 
tourniquet is applied to the upper arm to control bleeding.
A transverse incision is made on the volar (anterior) aspect of the forearm, 
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 located, 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. 
Hemostasis is achieved using electrocautery as needed. The incision is closed 
in layers: the subcutaneous tissue is approximated with absorbable sutures, and 
the skin is closed with non-absorbab
Sponsors
Maasstad Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients (>=18 years) with carpal tunnel syndrome confirmed by EMG or nerve ultrasound and choose surgical treatment are eligible for inclusion.
Exclusion criteria
Exclusion criteria: Previous surgical decompression of the median nerve at the ipselateral wrist or forearm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) at twelve months follow-up. The BCTQ is a carpal tunnel syndrome-specific, patient-reported outcomes instrument that comprises two subscales: the Symptom Severity Scale (SSS), which includes eleven questions about CTS symptoms, and the Functional Status Scale (FSS), which includes eight questions about overall functional status, each scored from 1 to 5. The sum of the scores for each subscale is divided by the number of questions in that subscale. The maximum score is 5.0, indicating the worst possible condition. The lowest score is 1.0, with no CTS symptoms.11 The BCTQ SSS and FSS will be collected at baseline, six weeks, three months, six months, 12 and 24 months. See Table 1 and Figure 1, study protocol page 15, for an overview of the measurements and timeline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: - BCTQ FSS - BCTQ Total score; a weighted mean of the BCTQ SSS and FSS score. - Residual symptoms; presence of preoperative symptoms after carpal tunnel release (yes/no), will be assessed at six, 12 and 24 months. - Persistent CTS; preoperative symptoms have never completely disappeared after carpal tunnel release (yes/no), will be assessed at six weeks, three, six, 12 and 24 months. - Recurrence; recurrence of median nerve compression symptoms (incl. CTS) is defined as an asymptomatic period after carpal tunnel release of three months minimum followed by a recurrence of preoperative symptoms. Recurrence will be assessed at six, 12 and 24 months. - Pillar pain; characterised by the presence of tenderness or pain in the thenar or hypothenar area around the hook of the hamate and unciform process of the trapezium. Pillar pain will be assessed at six weeks, three, six and 12 months. - Secondary surgery; such as, but not limited to nerve decompression, internal or external neurolysis and flap reconstruction in the ipsilateral arm. This will be assessed at six weeks, three, six, 12 and 24 months. - (Return to) work: will be assessed using the QuickDASH work module and an additional question to investigate the time to Return to Work. Will be assessed at baseline, six weeks, three and six months. - 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. Sensibility will be tested at baseline, three, 12 and 24 months. - Tip-pinch strength: tip-to-tip pinch strength of the first and the second digits will be measured with a Baseline Pinch Gauge. The mean of three measurements will be taken at baseline, three, 12 and 24 months. - Complications/adverse events: such as, but not limited to, infection, seroma, and, tendon and neurovascular damage will be monitored and registered at all time points; six weeks, three, six, 12 and 24 months. - Qu | — |
Countries
Netherlands
Contacts
Public ContactI Domela Nieuwenhuis
Maasstad Ziekenhuis
Outcome results
None listed