Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Release, Ultrasound
Brief summary
The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.
Detailed description
The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.
Interventions
DEVICECarpal Tunnel Release
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.
Sponsors
Sonex Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance * 18 years of age or older * Agree to complete questionnaires over a 12-month period * Valid mobile phone number and email address to receive and answer questions
Exclusion criteria
• Age less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months | 12 months | To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function. |
| Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months | 12 months | To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported time to return to activities | Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months | Patient reported time to return to normal activities as measured in days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient reported satisfaction following carpal tunnel release | 2 weeks, 1,3,6 and 12 months | Patient reported satisfaction with the carpal tunnel release procedure on a 1-5 scale with higher numbers indicating greater satisfaction. |
| Patient reported symptom improvement following carpal tunnel release | 2 weeks, 1,3,6 and 12 months | Patient reported improvement in symptoms following carpal tunnel release, reported on a 1-5 scale with higher numbers indicating more symptom improvement. |
| Pain reported pain on numerical pain rating scale | Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months | Patient reported pain following carpal tunnel release, reported on an 11-point (0-10) numerical pain rating scale with higher numbers indicating more pain. |
Countries
United States
Outcome results
None listed