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Not yet recruiting NCT06997172

Short- to Medium-term Outcome of Minimally Invasive Carpal Tunnel Release

No phase Interventional Carpal Tunnel

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TCTR (thread carpal tunnel release), Standard-of-care.
Who it may be relevant to
Registry conditions: Carpal Tunnel. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Determining the Short- to Medium-term Outcome After Minimally Invasive Sonography Guided Release of the Carpal Tunnel Compared to Standard-of-care Open and Endoscopic Techniques: a Randomized Controlled Superiority Trial With an Internal Pilot-phase

Overview

The aim of the study is to determine whether minimally invasive, ultrasound-guided thread carpal tunnel release leads to faster functional recovery compared to standard open and endoscopic techniques in patients with carpal tunnel syndrome.

Detailed description

Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression disorder encountered in hand surgery. It affects a broad demographic, from young women (often linked to pregnancy and breastfeeding) and young men involved in manual labor, to elderly individuals. The condition causes pain, numbness, and functional impairment in the hand, which can progress to permanent disability if untreated. Typically, conservative treatment (e.g., night splints, corticosteroid injections) is the first step. However, when symptoms persist, surgical decompression of the median nerve becomes necessary.

The current gold standard for surgical treatment of CTS is open carpal tunnel release (OCTR). This involves making a 2-5 cm incision in the palm and cutting the transverse carpal ligament under direct vision. While effective in relieving nerve compression, this approach creates a scar in the load-bearing area of the palm, which can lead to prolonged post-operative pain, delayed wound healing, reduced grip strength, extended rehabilitation time and limitations in early hand use.

To address some of these drawbacks, endoscopic carpal tunnel release (ECTR) was developed. This technique uses a smaller incision at the wrist and a camera system to visualize and divide the ligament. While less invasive than OCTR, ECTR still involves an incision, and significant scar tissue may still develop, especially internally.

Both techniques require postoperative wound care, stitch removal, and carry risks of complications such as nerve or tendon injury, infection, or incomplete release. Additionally, these methods often result in delays in returning to work and daily activities, particularly burdensome for patients in physically demanding jobs.

In recent years, a novel percutaneous ultrasound-guided technique, known as thread carpal tunnel release (TCTR), has been introduced. This method uses two small puncture sites instead of incisions. Under real-time ultrasound guidance, a suture loop is passed around the transverse carpal ligament, which is then divided using a sawing motion. This technique bears several advantages including absence of external scar, reduced postoperative pain, no requirement for stitch removal, potential faster recovery allowing earlier return to normal function, daily activities and work.

The theoretical benefits of TCTR are supported by cadaveric and small clinical studies, but no large randomized controlled trials have yet compared TCTR directly with both open and endoscopic techniques. This study aims to fill that evidence gap by rigorously evaluating whether TCTR leads to quicker functional recovery, measured via validated functional assessments in a real-world clinical setting.

Interventions

  • Procedure TCTR (thread carpal tunnel release)
    Percutaneous sonography guided release of carpal tunnel release
  • Procedure Standard-of-care
    Open or endoscopic carpal tunnel release based on patients' and physicians' preferences

Primary outcome measures

  • The objective functional assessment of the BCTQ score at 2 weeks [Time frame: 2 weeks post-operative]
Secondary outcome measures (12)
  • The objective functional assessment of the BCTQ score [Time frame: 4 and 6 weeks and 6 month post-operative]
  • Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status. [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • The subjective symptom severity score of the BCTQ [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • Hand-specific health [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • Functional recovery time [Time frame: up to 6 months post-operative]
  • Recovery from pain [Time frame: up to 6 months post-operative]
  • Area of the median nerve [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • Range of motion [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • thenar atrophies [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • Strength in the abductor pollicis brevis [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • Two-point discrimination [Time frame: 2, 4 and 6 weeks and 6 months post-operative]
  • Grip strength [Time frame: 2, 4 and 6 weeks and 6 months post-operative]

Eligibility criteria

Inclusion criteria

  • Patient aged 18 years or older
  • Electroneurographically proven carpal tunnel syndrome
  • Informed Consent for trial participation

Exclusion criteria

  • Revision surgery
  • Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT06997172 · 2025-00406; mu25Kamphuis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗