Safety and Efficacy of Carpal Tunnel Release Using a New Surgical Knife With and Without Ultrasound Guidance: Comparative Study in 100 Cadaveric Specimens.

Purpose: The purpose of this study was to compare the safety and efficacy of the carpal tunnel release surgery in cadaveric specimens, using a newly developed surgical knife incorporating a guide, with and without ultrasound guidance. Methods: For this study, 100 fresh frozen human cadaveric hands, free from fractures or surgical antecedents, were used (mean age: 71.3 ± 15.8 years, 60 men and 40 women). The specimens were allocated into two groups of 50 to undergo carpal tunnel release with or without ultrasound guidance, using the knife and guide (KeriKnife, KeriMedical) by four experienced hand surgeons. Donor demographics and operated side were recorded. Following surgery, every surgeon reported the difficulty of cutting the ligament on a scale of 1 (easy) to 5 (difficult), whether the ligament was completely cut, and whether the intervention caused any injuries to the surrounding structures. Results: There were no differences between the groups in terms of age, sex, weight, or side. Following surgery, the surgeons rated the difficulty similarly between the groups. The ligament was incompletely cut in one (2%) specimen that underwent the surgery with ultrasound, whereas it was incomplete in two (4%) that underwent the surgery without ultrasound, although the difference was not statistically significant. Furthermore, there was one injury in the group without ultrasound. Conclusions: The KeriKnife has shown its effectiveness for carpal tunnel release with or without ultrasound control. The only iatrogenic injury happened during the surgical release without ultrasound control. Type of study/level of evidence: Therapeutic III.