Dataset Information

Ultrasound-Guided Minimal Invasive Carpal Tunnel Release: An Optimized Algorithm.

ABSTRACT:

Purpose

To present a safety-optimized ultrasound-guided minimal invasive carpal tunnel release (CTR) procedure.

Materials and methods

104 patients (67 female, 37 male; mean age 60.6 ± 14.3 years, 95% CI 57.9 to 63.4 years) with clinical and electrophysiological verified typical carpal tunnel syndrome were referred for a high-resolution ultrasound of the median nerve and were then consecutively assigned for an ultrasound-guided CTR after exclusion of possible secondary causes of carpal tunnel syndrome such as tumors, tendovaginitis, ganglia and possible contraindications (e.g., crossing collateral vessels, nerve variations). Applying a newly adapted and optimized algorithm, basing on the work proposed by Petrover et al. CTR was performed using a button tip cannula which has several safety advantages: On the one hand, the button tip cannula acts as a blunt and atraumatic guiding splint for the subsequent insertion of the hook-knife, and on the other hands, it serves as a "hydro-inflation"-tool, i.e., a fluid-based expansion of the working-space is warranted during the whole procedure whenever needed.

Results

In all patients, successful releases were confirmed by the depiction of a completely transected transverse carpal ligament during and in the postoperative ultrasound-controls two weeks after intervention. All patients reported markedly reduction of symptoms promptly after this safety-optimized ultrasound-guided minimal invasive CTR and at the follow-up examination. No complications were evident.

Conclusion

The here proposed optimized algorithm assures a reliable and safe ultrasound-guided CTR and thus should be taken into account for this minimal invasive interventional procedure.

SUBMITTER: Loizides A

PROVIDER: S-EPMC8172390 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCarpal tunnel release (CTR) is a surgical treatment option for patients with carpal tunnel syndrome (CTS) symptoms that are unresponsive to conservative treatment. Most patients experience symptomatic relief after CTR regardless of the surgical technique. However, direct comparisons of the safety and effectiveness between CTR surgical techniques are limited. The purpose of this randomized controlled trial is to compare the safety and effectiveness of CTR with ultrasound guidance (CTR-US) versus mini-open CTR (mOCTR) in subjects with symptomatic CTS.Design and methodsTUTOR (Trial of Ultrasound guided CTR versus Traditional Open Release) is a randomized controlled trial in which 120 subjects at up to 12 sites in the United States will be randomized (2:1) to receive CTR-US or mOCTR. The primary endpoint of the study is the percentage of patients who return to normal daily activities within 3 days of the procedure. Secondary endpoints of the study are median time to return to normal daily activities, percentage of patients who return to work within 3 days of the procedure, median time to return to work, Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change score at 3 months, BCTQ Functional Status Scale (BCTQ-FSS) change score at 3 months, Numeric Pain Scale change score at 3 months, EuroQoL-5 Dimension 5-Level (EQ-5D-5L) change score at 3 months, and the incidence of device- or procedure-related adverse events at 3 months. Patient follow-up in this trial will continue for 1 year.Ethics and disseminationThis study was approved by a central institutional review board and ongoing trial oversight will be provided by a data safety monitoring board (DSMB). The authors intend to report the results of this trial at medical conferences and peer-reviewed journals. The outcomes of TUTOR will have important clinical and economic implications for all stakeholders involved in treating patients with CTS.Study registrationClinicalTrials.gov (https://clinicaltrials.gov): NCT05405218.Level of evidence1.

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