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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 (MeDe)

25 giugno 2026 aggiornato da: Maasstad Hospital

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Olanda
    • South Holland
      • Rotterdam, South Holland, Olanda, 3079 DZ
        • Reclutamento
        • Maasstad ziekenhuis
        • Contatto:
        • Sub-investigatore:
          • Sebastian Poggio Voormolen, BSc, PhD candidate
        • Sub-investigatore:
          • Ileen Domela Nieuwenhuis Nyegaard, MD, PhD candidate
        • Investigatore principale:
          • Niels W.L Schep, MD, PhD
      • Rotterdam, South Holland, Olanda, 3201 GZ
        • Reclutamento
        • Spijkenise Medisch Centrum
        • Contatto:
        • Sub-investigatore:
          • Sebastian Poggio Voormolen, BSc, PhD candidate
        • Sub-investigatore:
          • Ileen Domela Nieuwenhuis Nyegaard, MD, PhD candidate
        • Investigatore principale:
          • Niels W.L Schep, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: carpal tunnel release
Control group
Procedura: Carpal tunnel release
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.
Altro: carpal tunnel release combined with Lacertus release
Intervention group
Procedura: Combined carpal tunnel and lacertus release
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Lasso di tempo: At twelve months follow-up
Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
At twelve months follow-up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pillar pain
Lasso di tempo: From 6 weeks after surgery until 12 months of follow-up
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
From 6 weeks after surgery until 12 months of follow-up
(Return to) work using the QuickDASH work module.
Lasso di tempo: From enrollment until 6 months of follow-up.
From enrollment until 6 months of follow-up.
Sensibility
Lasso di tempo: From enrollment until 12 months of follow-up.
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.
From enrollment until 12 months of follow-up.
Tip-pinch strength
Lasso di tempo: From enrollment until 12 months of follow-up
Tip-to-tip pinch strength of the first and second digit will be measured with a baseline pinch gauge.
From enrollment until 12 months of follow-up
Cost-effectiveness of intervention
Lasso di tempo: From enrollment until 12 months of follow-up
Measured with health care resource utilisation and costs (iMCQ, iPCQ).
From enrollment until 12 months of follow-up
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)
Lasso di tempo: From enrollment until 12 months of follow-up
Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
From enrollment until 12 months of follow-up
Anchor questions
Lasso di tempo: At 12 months follow-up
Regarding patient satisfaction to analyse minimal clinically important difference (MCID)
At 12 months follow-up
Number of participants with residual, persistent en recurrent CTS symptoms
Lasso di tempo: From 6 weeks after surgery until 12 months of follow-up
From 6 weeks after surgery until 12 months of follow-up
Number of participants undergoing secondary surgery
Lasso di tempo: From 6 weeks until 12 months of follow-up.
This includes, but is not limited to, nerve decompression, internal or external neurolysis, and flap reconstruction in the ipsilateral arm.
From 6 weeks until 12 months of follow-up.
Number of participants that experienced complications or adverse events
Lasso di tempo: From enrollment until 12 months of follow-up.
Such as infection, seroma, and tendon and neurovascular damage.
From enrollment until 12 months of follow-up.
5-level EuroQol (EQ-5D-5L): Quality of life
Lasso di tempo: Will be assessed at baseline and at 12 months of follow-up.
Will be assessed using the 5-level EuroQol (EQ-5D-5L) questionnaire.
Will be assessed at baseline and at 12 months of follow-up.
Physical examination
Lasso di tempo: From enrollment until 12 months of follow-up.

OK-sign, FLP and FDP2 strength separately (compared to contralateral hand). Scratch collapse test over the carpal tunnel and Lacertus fibrosis (positive or negative).

Phalen and Tinel test (positive or negative).
From enrollment until 12 months of follow-up.
Exploratory ultrasound
Lasso di tempo: Will be assessed at baseline and 3 months.
Changes in median nerve cross-sectional diameter (mm) to evaluate postoperative changes in nerve size over time, measured by nerve ultrasound.
Will be assessed at baseline and 3 months.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Demographics
Lasso di tempo: At baseline
Age, sex, labour (blue versus white collar), hand dominance and medical history regarding comorbidities and hand-specific conditions
At baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Maasstad Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 maggio 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 febbraio 2028

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL-OMON57619
  • NL-005174 (Identificatore di registro: CCMO: Research with human participants)
  • NL87289.100.2 (Altro identificatore: ICTRP)
  • R24.082 (Altro identificatore: MEC-U)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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