At a glance
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Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures: a Prospective Randomized Controlled Trial
In Brief
A clinical study evaluating Cryotherapy for Ankle Fractures. Completed, enrolled 169 participants across 2 sites.
Detailed Summary
Ankle fractures are common injuries and cryotherapy is routinely used to reduce pain, swelling and local skin complications, both before and after surgery. However, the results on ankle surgery are contradictory. Despite the benefits of cryotherapy in the pre- and postoperative care of ankle surgery, lack of standardized protocols and few level-1 studies make difficult to appreciate the effectiveness. In addition, there's scarce evidence on the benefits from the preoperative use of cryotherapy. The aim of this study is to report the results with the use of third generation cryotherapy in the preoperative treatment of ankle fractures. Third generation devices use computed cryotherapy to deliver gradual changes in pressure and temperature. The software produces a progressive drop in temperature and a controlled slow return to room temperature environment, avoiding reactive vasodilation. Time to surgery, pain, opioids intake, and local skin complications have been investigated. Methods 169 patients with ankle fracture were randomized in 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 demand (including morphine or acetaminophen) were recorded. The development of skin complications was assessed daily. BMI and number of cigarettes smoked were also recorded.
Study Details
Timeline
Interventions
Treatment group: the ankle was immobilized in a walking boot, then a third-generation cryotherapy device (Z- One®, Zamar) was applied daily for 2 hours two times a day up to the day of surgery. The walking boot was removed when the cryotherapy device was applied.