Open vs. Ultrasound-Guided Carpal Tunnel Release
ConditionCarpal Tunnel Syndrome (CTS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAUVA General Trauma Hospital Salzburg
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Participants will be recruited during routine clinical consultations at the outpatient clinics of the participating centers. Patients fulfilling the inclusion criteria will be informed about the study by their treating physicians. Participation is voluntary and does not affect the quality of medical care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Open Surgical Carpal Tunnel Release (OSCTR)
Procedure/SurgeryOpen surgical decompression of the carpal tunnel (OSCTR) is performed at UKH Salzburg as the established standard surgical treatment for carpal tunnel syndrome. The procedure involves open surgical release of the flexor retinaculum. Intraoperative findings and immediate complications are documented.
Ultrasound-Guided Carpal Tunnel Release (USGCTR)
Procedure/SurgeryUltrasound-guided carpal tunnel release (USGCTR) is performed at the University Institute of Radiology of the Paracelsus Medical Private University. The minimally invasive procedure involves release of the flexor retinaculum under continuous sonographic visualization through a minimal incision at the distal forearm or wrist crease. Intraoperative findings and immediate complications are documented.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Open Surgical Carpal Tunnel Release (OSCTR)1 intervention
Group B: Ultrasound-Guided Carpal Tunnel Release (USGCTR)1 intervention
Trial outcomes
Primary outcomes
1
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score
Mean difference in the change in the Boston Carpal Tunnel Questionnaire (BCTQ) score, combining the Symptom Severity Scale and Functional Status Scale, from the preoperative assessment (T0) to the 3-month postoperative assessment (T3).
Time frame
Baseline to 3 months postoperativelySecondary outcomes
1
Pain Intensity - Visual Analog Scale (VAS), 0-10
Change in pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10.
Time frame
Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively2
Subjective Hand Function - Single Assessment Numeric Evaluation (SANE), 0-100%
Subjective hand function measured using the Single Assessment Numeric Evaluation (SANE), ranging from 0 to 100%.
Time frame
Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively3
Time to Full Return to Work - Number of Days After Surgery
Number of days from surgery until full return to work.
Time frame
Up to 3 months postoperatively4
Postoperative Complications - Frequency of Wound Infection, Persistent Numbness, and Revision Surgery
Frequency of wound infections, persistent numbness, or required revision procedures.
Time frame
Within 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
AUVA General Trauma Hospital Salzburg
Lead sponsor
Salzburger Landeskliniken
Collaborator
Paracelsus Medical University
Collaborator
Source ClinicalTrials.gov