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NCT07814547
Open vs. Ultrasound-Guided Carpal Tunnel Release
Conditions: Carpal Tunnel Syndrome (CTS)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 200
Sponsor: AUVA General Trauma Hospital Salzburg
Location: AUVA General Trauma Hospital Salzburg Salzburg
Summary
Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy. Open Surgical Carpal Tunnel Release (OSCTR) remains the gold standard, while minimally invasive Ultrasound-Guided Carpal Tunnel Release (USGCTR) offers potential advantages including reduced postoperative morbidity and faster recovery. This prospective, multicenter observational cohort study compares the clinical outcomes, patient-reported outcomes, and socioeconomic impact of USGCTR versus OSCTR. A total of 200 patients, with 100 patients per cohort, will be included. Patient assignment is based on the participating center's standard of care. Follow-up assessments are performed preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months after surgery.
Eligibility Criteria
Inclusion Criteria:
* Electrophysiologically verified Carpal Tunnel Syndrome by EMG/nerve conduction studies, with the examination not older than 6 months at the time of inclusion.
* Previous documented and exhausted conservative treatment
* Existing indication for surgery that has been discussed with the patient and the patient's explicit wish to undergo surgical treatment.
* Ability to provide informed consent and written informed consent
* Age ≥18 years.
Exclusion Criteria:
* Previous surgery at the affected location or revision procedures.
* Pre-existing nerve lesions of the upper extremity, including traumatic transections or proximal injuries.
* Manifest polyneuropathy.
* Foreseeable loss to follow-up, for example inability to contact the participant or insufficient compliance, before the critical 3-month follow-up.
* Age under 18 years.
Source: ClinicalTrials.gov (NCT07814547). StuddyBuddy aggregates publicly available trial information.