Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures

Ankle Fractures Clinical Trial

— Cryotherapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06396364
• Other study ID #: cryotherapy012021.n01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliera San Camillo Forlanini
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 0.9 with a significance level of 0.05 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 0.05 was used in all analyses mentioned. For the statistical analysis of data, IBM SPSS Statistics software version 28 was used

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients admitted to the emergency department with an ankle fracture

Exclusion Criteria:

• Open fractures

• Fracture-dislocations which required external fixation

• Patients with one or more associated fractures

• Patients with a diagnose of major trauma

• Patients who were not able to complain with the pre- and post-surgical indications

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Device:
• Cryotherapy
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.

Locations

Country	Name	City	State
Italy	A.O. San Camillo Forlanini	Rome
Italy	A.O. San camillo Forlanini	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Camillo Forlanini

Country where clinical trial is conducted

Italy, 

References & Publications (8)

De Boer AS, Van Lieshout EMM, Van Moolenbroek G, Verhofstad MHJ, Den Hartog D. Computer-Controlled Cooling in Operatively Treated Ankle or Hindfoot Fractures: A Retrospective Case-Control Study. J Foot Ankle Surg. 2021 Nov-Dec;60(6):1131-1136. doi: 10.105 — View Citation

Douzi W, Guillot X, Bon D, Seguin F, Boildieu N, Wendling D, Tordi N, Dupuy O, Dugue B. 1H-NMR-Based Analysis for Exploring Knee Synovial Fluid Metabolite Changes after Local Cryotherapy in Knee Arthritis Patients. Metabolites. 2020 Nov 13;10(11):460. doi — View Citation

Finger A, Teunis T, Hageman MG, Ziady ER, Ring D, Heng M. Association Between Opioid Intake and Disability After Surgical Management of Ankle Fractures. J Am Acad Orthop Surg. 2017 Jul;25(7):519-526. doi: 10.5435/JAAOS-D-16-00505. — View Citation

Helmerhorst GT, Lindenhovius AL, Vrahas M, Ring D, Kloen P. Satisfaction with pain relief after operative treatment of an ankle fracture. Injury. 2012 Nov;43(11):1958-61. doi: 10.1016/j.injury.2012.08.018. Epub 2012 Aug 16. — View Citation

Herrera E, Sandoval MC, Camargo DM, Salvini TF. Motor and sensory nerve conduction are affected differently by ice pack, ice massage, and cold water immersion. Phys Ther. 2010 Apr;90(4):581-91. doi: 10.2522/ptj.20090131. Epub 2010 Feb 25. — View Citation

Lin S, Xie J, Yao X, Dai Z, Wu W. The Use of Cryotherapy for the Prevention of Wound Complications in the Treatment of Calcaneal Fractures. J Foot Ankle Surg. 2018 May-Jun;57(3):436-439. doi: 10.1053/j.jfas.2017.08.002. — View Citation

Scheer RC, Newman JM, Zhou JJ, Oommen AJ, Naziri Q, Shah NV, Pascal SC, Penny GS, McKean JM, Tsai J, Uribe JA. Ankle Fracture Epidemiology in the United States: Patient-Related Trends and Mechanisms of Injury. J Foot Ankle Surg. 2020 May-Jun;59(3):479-483 — View Citation

Wilke B, Weiner RD. Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Clin Podiatr Med Surg. 2003 Apr;20(2):307-22. doi: 10.1016/S0891-8422(03)00009-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to surgery	hours	From enrollment to surgery
Secondary	VAS Score	VAS Score - Visual analogue scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 (pain as bad as it it could possibly be).	6 hours
Secondary	Skin complications	The onset of preoperative skin complication as skin blisters have been recorded. complications	up to surgery
Secondary	Morphine intake	Pain was evaluated as the number of Morphine vials intake	up to surgery