CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 169 enrolled
Drug / intervention
Cryotherapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06396364
NCT06396364N/ACompleted

Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures: a Prospective Randomized Controlled Trial

Azienda Ospedaliera San Camillo Forlanini·interventional·Posted May 2, 2024·Updated May 2, 2024

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Fractures
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 2, 2024
Enrollment StartFeb 1, 2021
Primary CompletionAug 1, 2023
Study CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 2.2 years ago

Interventions

Cryotherapydevice

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.