Clinical trial NCT06997172: Short- to Medium-term Outcome of Minimally Invasive Carpal Tunnel Release
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel
Keywords: Percutaneous sonography guided release
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The objective functional assessment of the BCTQ score at 2 weeks
timeFrame: 2 weeks post-operative
Secondary outcomes:
measure: The objective functional assessment of the BCTQ score
timeFrame: 4 and 6 weeks and 6 month post-operative
measure: Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status.
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: The subjective symptom severity score of the BCTQ
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Hand-specific health
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Functional recovery time
timeFrame: up to 6 months post-operative
measure: Recovery from pain
timeFrame: up to 6 months post-operative
measure: Area of the median nerve
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Range of motion
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: thenar atrophies
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Strength in the abductor pollicis brevis
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Two-point discrimination
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Grip strength
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Pinch strength
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Pain intensity
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
measure: Outcome satisfaction
timeFrame: 2, 4 and 6 weeks and 6 months post-operative
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Saskia Kamphuis
role: STUDY_CHAIR
References: