Trial reportJournal of orthopaedic surgery and research2026
Third-generation cryotherapy reduces time to surgery and local complications in patients with ankle fractures: a prospective randomised controlled trial.
Trial report in Journal of orthopaedic surgery and research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06396364 (Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures), which is not on this map. Not yet cited in PubMed.
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Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures: a Prospective Randomized Controlled Trial
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11 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundAnkle fractures are common, and cryotherapy is routinely used to reduce pain, swelling and local skin complications, both before and after surgery. The aim of this study is to report the results with the use of pre-operative third-generation cryotherapy (Z-One
methods169 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.
resultsThe 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).
conclusionPreoperative 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).
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