Trial Outcomes & Findings for Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR) (NCT NCT05405218)
NCT ID: NCT05405218
Last Updated: 2025-06-05
Results Overview
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
COMPLETED
NA
122 participants
3 Month Follow-Up
2025-06-05
Participant Flow
Enrollment in the TUTOR study began on August 8, 2022, and 122 subjects were enrolled. Enrollment was completed on February 2, 2023. Per the protocol, a subject was considered enrolled once they had signed the informed consent form, met all inclusion and exclusion criteria, and completed carpal tunnel release (CTR) via their assigned treatment method.
No pre-assignments for this study
Participant milestones
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
28
|
|
Overall Study
COMPLETED
|
94
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Baseline characteristics by cohort
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=94 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated using the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 14 • n=5 Participants
|
57 years
STANDARD_DEVIATION 14 • n=7 Participants
|
57 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Month Follow-UpPopulation: Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change at 3 months
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=89 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
|
-1.5 units on a scale
Interval -1.6 to -1.4
|
-1.5 units on a scale
Interval -1.7 to -1.4
|
PRIMARY outcome
Timeframe: 3 Month Follow-UpPopulation: Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) change at 3 months
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=89 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
|
-0.8 units on a scale
Interval -0.9 to -0.7
|
-0.8 units on a scale
Interval -1.0 to -0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Month Follow-UpPopulation: Participants with Procedure and/or Device-Related Adjudicated Adverse Events
Participants with adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device or definitely related or probably related to the procedure will be included in this endpoint. The incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent an endpoint of the study.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=94 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Participants With Device or Procedure Related Adverse Events
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Month Follow-UpPopulation: Numeric Pain Scale change at 3 months
The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=89 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Numeric Pain Scale Change
|
-3.2 Unit
Interval -3.5 to -2.8
|
-3.8 Unit
Interval -4.4 to -3.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Month Follow-UpPopulation: EuroQol 5-Dimension 5-Level (EQ-5D-5L) change at 3 months
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change scores in the EQ-5D-5L from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=89 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change
|
0.11 units on a scale
Interval 0.09 to 0.14
|
0.12 units on a scale
Interval 0.07 to 0.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Month Follow-UpPopulation: Time to return to work in days among employed subjects
The time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=56 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=19 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Time to Return to Work Among Employed Subjects
|
3.0 Days
Interval 1.0 to 8.5
|
4.0 Days
Interval 1.0 to 15.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Month Follow-UpPopulation: Participants who returned to normal daily activities within 3 days postoperatively
The time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=94 Participants
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 Participants
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively
|
55 Participants
|
20 Participants
|
Adverse Events
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
Mini Open Carpal Tunnel Release (mOCTR)
Serious adverse events
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=94 participants at risk
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 participants at risk
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Surgical and medical procedures
Nerve Injury - Digital-Median
|
1.1%
1/94 • Number of events 1 • Adverse events were collected out to 1 year.
AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
|
0.00%
0/28 • Adverse events were collected out to 1 year.
AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
|
Other adverse events
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=94 participants at risk
Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study.
|
Mini Open Carpal Tunnel Release (mOCTR)
n=28 participants at risk
Participants who were randomized to and treated with the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Nerve Injury - Digital-Median: Neurapraxia
|
1.1%
1/94 • Number of events 1 • Adverse events were collected out to 1 year.
AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
|
0.00%
0/28 • Adverse events were collected out to 1 year.
AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
|
|
Musculoskeletal and connective tissue disorders
Wound Dehiscence/ delayed healing
|
0.00%
0/94 • Adverse events were collected out to 1 year.
AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
|
3.6%
1/28 • Number of events 1 • Adverse events were collected out to 1 year.
AE could be reported 3 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. 3) AE identified by the site during the review of the subject-uploaded wound healing images. If the site identifies a potential AE based on an image review or is notified of a potential AE by the subject, confirmation of the AE will occurred by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
|
Additional Information
Amy Stegner, Vice President Clinical Affairs
Sonex Health, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place