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

NCT06396364 | Completed

• 1 other identifier: cryotherapy012021.n01
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

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, 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.

Conditions

Ankle Fractures

Keywords

cryotherapy; ankle fracture; ankle surgery; time to surgery; surgical site infections

Outcome Measures

Primary Outcomes (1)

• time to surgery

  hours

  From enrollment to surgery

Secondary Outcomes (3)

• VAS Score

  6 hours

• Skin complications

  up to surgery

• Morphine intake

  up to surgery

Study Arms (2)

Cryotherapy

EXPERIMENTAL

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.

Device: Cryotherapy

Immobilization and elevation

ACTIVE COMPARATOR

The leg was immobilized into a half cats and elevation of the injured limb was indicated before surgery.

Device: Cryotherapy

Interventions

Cryotherapy DEVICE

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.

Also known as: Third generation cryotherapy

Cryotherapy; Immobilization and elevation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the emergency department with an ankle fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera San Camillo Forlanini: lead

Study Sites (2)

A.O. San Camillo Forlanini

Rome, 00152, Italy

Location

A.O. San camillo Forlanini

Rome, Italy

Location

Related Publications (8)

• 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.

  PMID: 20185615 RESULT

• 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.

  PMID: 22901424 RESULT

• 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.

  PMID: 12776983 RESULT

• 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: 10.3390/metabo10110460.

  PMID: 33202890 RESULT

• 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: 10.1053/j.jfas.2021.04.014. Epub 2021 Apr 21.

  PMID: 34039509 RESULT

• 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. doi: 10.1053/j.jfas.2019.09.016.

  PMID: 32354504 RESULT

• 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.

  PMID: 29685558 RESULT

• 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.

  PMID: 28574942 RESULT

MeSH Terms

Conditions

Ankle Fractures; Surgical Wound Infection

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gennaro Pipino, M.D., Prof.

  San Raffaele University, Milan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Orthopaedic Sugeon, principal investigator

Model Details: 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. Pain was evaluated according to the Visual Analogue Scale (VAS) and the analgesic drug demand (including morphine or acetaminophen). The Bod

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: February 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: the will be available with the published manuscript, or by asking to the corresponding author under reasonable request with no time restriction
• Access Criteria: contacting the corresponding author (Alessio Giai Via) by e-mail

Locations

IT (2)