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

NCT ID: NCT06997172

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Carpal Tunnel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TCTR (thread carpal tunnel release)

Percutaneous sonography guided release of carpal tunnel

Group Type: EXPERIMENTAL

TCTR (thread carpal tunnel release)

Intervention Type: PROCEDURE

Percutaneous sonography guided release of carpal tunnel release

Standard of care technique

Standard of care technique (consisting of either the open or endoscopic technique) release of carpal tunnel

Group Type: ACTIVE_COMPARATOR

Standard-of-care

Intervention Type: PROCEDURE

Open or endoscopic carpal tunnel release based on patients' and physicians' preferences

Interventions

TCTR (thread carpal tunnel release)

Percutaneous sonography guided release of carpal tunnel release

Intervention Type: PROCEDURE

Standard-of-care

Open or endoscopic carpal tunnel release based on patients' and physicians' preferences

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saskia Kamphuis

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Central Contacts

Saskia Kamphuis, MD

Role: CONTACT

Saskia.Kamphuis@usb.ch

+41 61 556 54 82

Facility Contacts

Saskia Kamphuis, MD

Role: primary

Saskia.Kamphuis@usb.ch

+41 61 556 54 82

Other Identifiers

2025-00406; mu25Kamphuis

Identifier Type: -

Identifier Source: org_study_id