Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396364
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-24
Brief Title:
Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures
Sponsor:
Azienda Ospedaliera San Camillo Forlanini
Organization:
Azienda Ospedaliera San Camillo Forlanini
Study Overview
Official Title:
Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures a Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cryotherapy
Brief 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 theres 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
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
Detailed Description:
The aim of this study is to assess the effects of third generation cryotherapy on time to surgery pain opioids intake and local skin complications Although the use of cryotherapy is traditionally believed to reduce pain swelling local skin complications and the need of analgesia the results on ankle surgery are not well reported and still contradictory The working hypothesis is that third generation cryotherapy is a safe reduces time to surgery and is useful in the surgical management of ankle fractures The investigators analyzed the prospectively collected data of 169 patients with ankle fracture treated with open reduction and internal fixation ORIF Patients were randomized in two groups at the time of the diagnosis in the emergency department The treatment group T 89 patients were treated with a third-generation cryotherapy device Z- One Zamar which was applied daily for 2 hours two times a day up to the day of surgery The leg was immobilized in a walking boot which was removed when the cryotherapy device was applied The control group C 80 patients did not use cryotherapy before surgery the leg was immobilized into a half cats and elevation of the injured limb was indicated Patients were collected in two different hospitals Azienda Ospedaliera San Camillo Forlanini -Roma and Ospedale San Paolo - Civitavecchia between 2021 and 2023 All patients had signed a written consent and the study was approved by the local ethic committee
After the diagnosis was made and surgical treatment was indicated the patient was hospitalized in the department of orthopedic and trauma surgery
A power analysis was performed to evaluate the sample size necessary to guarantee a power of at least 09 with a significance level of 005 using preliminary data on time to surgery
Univariate descriptive analysis of the variables under study was carried out by calculating the centrality and variability indices for the quantitative variables and frequency tables for the variables
The homogeneity of the control group and the treatment group for the variables sex age type of fracture diabetes hypercholesterolemia venous insufficiency and BMI class were checked Depending on the nature of the variables a t-test or a chi-square test was used
Any significant differences between the treatment and control groups were assessed using independent samples t-tests for quantitative variables and chi-square tests for qualitative variables Where the sample size was not sufficient the non-parametric Mann-Whitney test for independent samples was used
An alpha significance level of 005 was used in all analyses mentioned For the statistical analysis of data IBM SPSS Statistics software version 28 was used
After the diagnosis was made and surgical treatment was indicated the patient was hospitalized in the department of orthopedic and trauma surgery
A power analysis was performed to evaluate the sample size necessary to guarantee a power of at least 09 with a significance level of 005 using preliminary data on time to surgery
Univariate descriptive analysis of the variables under study was carried out by calculating the centrality and variability indices for the quantitative variables and frequency tables for the variables
The homogeneity of the control group and the treatment group for the variables sex age type of fracture diabetes hypercholesterolemia venous insufficiency and BMI class were checked Depending on the nature of the variables a t-test or a chi-square test was used
Any significant differences between the treatment and control groups were assessed using independent samples t-tests for quantitative variables and chi-square tests for qualitative variables Where the sample size was not sufficient the non-parametric Mann-Whitney test for independent samples was used
An alpha significance level of 005 was used in all analyses mentioned For the statistical analysis of data IBM SPSS Statistics software version 28 was used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None