Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

110

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Niederlande
    • South Holland
      • Rotterdam, South Holland, Niederlande, 3079 DZ
        • Rekrutierung
        • Maasstad ziekenhuis
        • Kontakt:
        • Unterermittler:
          • Sebastian Poggio Voormolen, BSc, PhD candidate
        • Unterermittler:
          • Ileen Domela Nieuwenhuis Nyegaard, MD, PhD candidate
        • Hauptermittler:
          • Niels W.L Schep, MD, PhD
      • Rotterdam, South Holland, Niederlande, 3201 GZ
        • Rekrutierung
        • Spijkenise Medisch Centrum
        • Kontakt:
        • Unterermittler:
          • Sebastian Poggio Voormolen, BSc, PhD candidate
        • Unterermittler:
          • Ileen Domela Nieuwenhuis Nyegaard, MD, PhD candidate
        • Hauptermittler:
          • Niels W.L Schep, MD, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: carpal tunnel release
Control group
Verfahren: 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.
Sonstiges: carpal tunnel release combined with Lacertus release
Intervention group
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pillar pain
Zeitfenster: 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.
Zeitfenster: From enrollment until 6 months of follow-up.
From enrollment until 6 months of follow-up.
Sensibility
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient Demographics
Zeitfenster: At baseline
Age, sex, labour (blue versus white collar), hand dominance and medical history regarding comorbidities and hand-specific conditions
At baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Maasstad Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Mai 2026

Primärer Abschluss (Geschätzt)

1. Februar 2028

Studienabschluss (Geschätzt)

1. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

11. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NL-OMON57619
  • NL-005174 (Registrierungskennung: CCMO: Research with human participants)
  • NL87289.100.2 (Andere Kennung: ICTRP)
  • R24.082 (Andere Kennung: MEC-U)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren