Third-generation cryotherapy reduces time to surgery and local complications in patients with ankle fractures: a prospective randomised controlled trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: , Zamar, Italy) in the management of patients with ankle fractures. We investigated the time to surgery, pain, opioid intake, and local skin complications. METHODS: 169 patients with ankle fracture were randomised into two groups, the cryotherapy group (89 patients) and the control group (C: 80 patients). The time-to-surgery, Visual Analogue Scale (VAS) and the analgesic drug demands (Morphine Sulfate 10 mg/ml solution for injection) were recorded. The development of skin complications was assessed on a daily basis. BMI and the number of cigarettes smoked were also recorded. RESULTS: The mean time-to-surgery was shorter in patients treated with cryotherapy compared to the control group (34.78 h vs. 91.44 h, p < 0.001). Significant differences between treatments and controls were found for VAS, morphine intake (number of vials), and skin complications. The mean preoperatory VAS and morphine consumption were lower in the cryotherapy group compared to controls (mean VAS 2.04 vs. 5.9, mean morphine consumption 0.1 mg vs. 0.83 mg). In the cryotherapy group, 4.5% of patients developed a skin complication compared to 28.7% of the control group; 85% of skin-related problems occurred in the non-cryotherapy group (p < 0.001). CONCLUSION: Preoperative third-generation cryotherapy is effective in reducing time to surgery, preoperative pain, and opioid intake in patients hospitalised for ankle fractures. It is also effective in reducing the occurrence of skin complications. No major complications related to the use of the device were reported. Third-generation cryotherapy is useful in the perioperative management of patients necessitating surgery for ankle fractures. Clinical Trial Registration NCT06396364. Level of evidence I (RCT).
Institutions: Azienda Ospedaliera San Camillo-Forlanini, IRCCS Ospedale San Raffaele, Ospedale di Bolzano, University Hospital in Halle, Link Campus University, Azienda Sanitaria dell'Alto Adige, Martin Luther University Halle-Wittenberg, Queen Mary University of London, Mile End Hospital, Azienda Ospedaliera Sant'Andrea, Sapienza University of Rome
Language: English
Topic: Foot and Ankle Surgery
Subfield: Orthopedics and Sports Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,090
OpenAlex ID: W7135402473