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Expert Review of Medical Devices Volume 20, 2023 - Issue 7
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Original Research

Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique

Kyle R. Eberlina Massachusetts General Hospital, Boston, MA, USAView further author information
,
Benjamin P. Amisb ATX Orthopedics, Austin, TX, USAView further author information
,
Thomas P. Berkbiglerc Midwest Orthopedic Group, Farmington, MO, USAView further author information
,
Christopher J. Dyd Washington University, St. Louis, MO, USAView further author information
,
Mark D. Fischere Twin Cities Orthopedics, Plymouth, MN, USAView further author information
,
James L. Gluckf Kansas Orthopaedic Center, Wichita, KS, USAView further author information
,
F. Thomas D. Kaplang Indiana Hand to Shoulder, Indianapolis, IN, USAView further author information
,
Thomas J. McDonaldh Sierra Orthopedic Institute, Sonora, CA, USAView further author information
,
Larry E. Milleri Miller Scientific, Johnson City, TN, USACorrespondence[email protected]
View further author information
,
Alexander Palmerj Sano Orthopedics, Lee’s Summit, MO, USAView further author information
,
Paul E. Perryk Tri-State Orthopaedic Surgeons, Newburgh, IN, USAView further author information
,
Marc E. Walkerl University of Mississippi Medical Center, Jackson, MS, USAView further author information
&
James F. Wattm Orthopaedic Associates, Fort Walton Beach, FL, USAView further author information
 show all
Pages 597-605 | Received 25 Apr 2023, Accepted 23 May 2023, Published online: 30 May 2023

Figures & data

Table 1. Demographic characteristics of patients treated with CTR-US or mOCTR.

Figure 1. Device used for carpal tunnel release with ultrasound guidance. Key device characteristics include: 1) blunt dissecting rigid polymer tip; 2) two laterally located polymer balloons (inflated in figure); 3) retractable stainless-steel retrograde cutting blade (in active position in figure); 4) handle housing device controls.

Figure 1. Device used for carpal tunnel release with ultrasound guidance. Key device characteristics include: 1) blunt dissecting rigid polymer tip; 2) two laterally located polymer balloons (inflated in figure); 3) retractable stainless-steel retrograde cutting blade (in active position in figure); 4) handle housing device controls.

Table 2. Clinical characteristics of patients treated with CTR-US or mOCTR.

Table 3. Procedural details in patients treated with CTR-US or mOCTR.

Figure 2. Representative wound healing images in heavy manual laborers 1 week after CTR-US using a wrist incision (left) and mOCTR using a palmar incision (right).

Abbreviations: CTR-US=carpal tunnel release with ultrasound guidance; mOCTR, mini-open carpal tunnel release.
Figure 2. Representative wound healing images in heavy manual laborers 1 week after CTR-US using a wrist incision (left) and mOCTR using a palmar incision (right).

Figure 3. BCTQ-SSS and BCTQ-FSS scores over 3 months following CTR-US and mOCTR. Plotted values are baseline-adjusted least squares mean change and 95% confidence interval. (top) at 3 months, the mean change for BCTQ-SSS was − 1.46 for CTR-US and − 1.54 for mOCTR (p = 0.46 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 1.14-point decrease denoted by the green shaded area [Citation18]. (bottom) at 3 months, the mean change for BCTQ-FSS was − 0.83 for CTR-US and − 0.84 for mOCTR (p = 0.92 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 0.74-point decrease denoted by the green shaded area [Citation18].

Abbreviations: BCTQ-FSS=Boston Carpal Tunnel Questionnaire Functional Status Scale; BCTQ-SSS=Boston Carpal Tunnel Questionnaire Symptom Severity Scale; CTR-US=carpal tunnel release with ultrasound guidance; mOCTR, mini-open carpal tunnel release.
Figure 3. BCTQ-SSS and BCTQ-FSS scores over 3 months following CTR-US and mOCTR. Plotted values are baseline-adjusted least squares mean change and 95% confidence interval. (top) at 3 months, the mean change for BCTQ-SSS was − 1.46 for CTR-US and − 1.54 for mOCTR (p = 0.46 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 1.14-point decrease denoted by the green shaded area [Citation18]. (bottom) at 3 months, the mean change for BCTQ-FSS was − 0.83 for CTR-US and − 0.84 for mOCTR (p = 0.92 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 0.74-point decrease denoted by the green shaded area [Citation18].

Figure 4. Numeric Pain Scale scores over 3 months following CTR-US and mOCTR. Plotted values are baseline-adjusted least squares mean change and 95% confidence interval. At 3 months, the mean change was − 3.2 for CTR-US and − 3.8 for mOCTR (p = 0.09 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 2-point decrease denoted by the green shaded area [Citation19].

Abbreviations: CTR-US=carpal tunnel release with ultrasound guidance; mOCTR=mini-open carpal tunnel release.
Figure 4. Numeric Pain Scale scores over 3 months following CTR-US and mOCTR. Plotted values are baseline-adjusted least squares mean change and 95% confidence interval. At 3 months, the mean change was − 3.2 for CTR-US and − 3.8 for mOCTR (p = 0.09 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 2-point decrease denoted by the green shaded area [Citation19].

Figure 5. EQ-5D-5 L scores over 3 months following CTR-US and mOCTR. Plotted values are baseline-adjusted least squares mean change and 95% confidence interval. At 3 months, the mean change was 0.11 for CTR-US and 0.12 for mOCTR (p = 0.90 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 0.09-point increase denoted by the green shaded area [Citation20].

Abbreviations: CTR-US=carpal tunnel release with ultrasound guidance; EQ-5D-5 L=EuroQoL 5-Dimension 5-Level; mOCTR=mini-open carpal tunnel release.
Figure 5. EQ-5D-5 L scores over 3 months following CTR-US and mOCTR. Plotted values are baseline-adjusted least squares mean change and 95% confidence interval. At 3 months, the mean change was 0.11 for CTR-US and 0.12 for mOCTR (p = 0.90 between groups). The mean change in each group was statistically significant compared to baseline (both p < 0.001) and exceeded the minimal clinically important difference of a 0.09-point increase denoted by the green shaded area [Citation20].

Table 4. Results of intention-to-treat, as-randomized analysis.*

Supplemental material

Supplemental Material

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Data availability statement

Raw data will not be available because the clinical trial remains in progress.

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