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Background <p>Ankle 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<sup>®</sup>, Zamar, Italy) in the management of patients with ankle fractures. We investigated the time to surgery, pain, opioid intake, and local skin complications.</p> Methods <p>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&#xa0;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.</p> Results <p>The mean time-to-surgery was shorter in patients treated with cryotherapy compared to the control group (34.78&#xa0;h vs. 91.44&#xa0;h, <i>p</i> &lt; 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&#xa0;mg vs. 0.83&#xa0;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 (<i>p</i> &lt; 0.001).</p> Conclusion <p>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.</p> <p><?qj left?><?noindent??><i>Clinical Trial Registration </i>NCT06396364.</p> <p><?qj left?><?noindent??><i>Level of evidence </i>I (RCT).</p>

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Third-generation cryotherapy reduces time to surgery and local complications in patients with ankle fractures: a prospective randomised controlled trial

  • 期刊论文

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  • 发表日期：

    2026年3月14日

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  • Riccardo Maria Lanzetti,
  • Alessio Giai Via,
  • Francesco Anzano,
  • Gennaro Pipino,
  • Raffaella Alonzo,
  • Carmelo D’Arrigo,
  • Stefania De Sanctis,
  • Marco Spoliti,
  • Giovanna Fidone,
  • Filippo Migliorini,
  • Nicola Maffulli

摘要

Background

Ankle 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®, 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).