Ankle FracturesCryotherapyNCT06396364
Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures
A study testing Cryotherapy in people with Ankle Fractures, run by Azienda Ospedaliera San Camillo Forlanini at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the emergency department with an ankle fracture
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
A.O. San Camillo Forlanini
Rome, 00152
A.O. San camillo Forlanini
Rome
About this study
Official title: Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures: a Prospective Randomized Controlled Trial
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.
Read the 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 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
- Conditions
- Ankle Fractures
- Being tested
- Cryotherapy
- Keywords
- cryotherapy, ankle fracture, ankle surgery, time to surgery, surgical site infections
- Medical subject headings
- Ankle Fractures, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Also called Third generation 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to surgery
hours
Measured: From enrollment to surgery
Secondary outcomes (3)
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).
Measured: 6 hours
Skin complications
The onset of preoperative skin complication as skin blisters have been recorded. complications
Measured: up to surgery
Morphine intake
Pain was evaluated as the number of Morphine vials intake
Measured: up to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Feb 2021
- Primary completion1 Aug 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Camillo Forlanini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giai Via, Azienda Ospedaliera San Camillo Forlanini
- Investigators
- Gennaro Pipino, M.D., Prof., Study chair, San Raffaele University, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396364
- Sponsor's protocol ID
- cryotherapy012021.n01
- Acronym
- Cryotherapy
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Publications
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.
PubMed 20185615Helmerhorst 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.
PubMed 22901424Wilke 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.
PubMed 12776983Douzi 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.
PubMed 33202890De 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.
PubMed 34039509Scheer 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.
PubMed 32354504Lin 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.
PubMed 29685558Finger 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.
PubMed 28574942Lanzetti RM, Giai Via A, Anzano F, Pipino G, Alonzo R, D'Arrigo C, De Sanctis S, Spoliti M, Fidone G, Migliorini F, Maffulli N. Third-generation cryotherapy reduces time to surgery and local complications in patients with ankle fractures: a prospective randomised controlled trial. J Orthop Surg Res. 2026 Mar 14;21(1):219. doi: 10.1186/s13018-025-06599-x.
PubMed 41832513
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Generation Cryotherapy Reduces Time to Surgery and Local Complication in Patients With Ankle Fractures: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06396364
- Acronym / sponsor ID
- Cryotherapy / cryotherapy012021.n01
- Conditions
- Ankle Fractures
- Keywords
- cryotherapy, ankle fracture, ankle surgery, time to surgery, surgical site infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Camillo ForlaniniUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Device: CryotherapyPatients 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. |
| Immobilization and elevation | Active comparator | Device: CryotherapyThe leg was immobilized into a half cats and elevation of the injured limb was indicated before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the emergency department with an ankle fracture
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyAlso: Third generation cryotherapyTreatment 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. | Device | Cryotherapy, Immobilization and elevation |
Primary outcome
time to surgery
Time frame: From enrollment to surgery
hours
3 secondary outcomes
VAS Score
Time frame: 6 hours
Skin complications
Time frame: up to surgery
Morphine intake
Time frame: up to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Results publication: PubMed 20185615Herrera 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.
- Results publication: PubMed 22901424Helmerhorst 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.
- Results publication: PubMed 12776983Wilke 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.
- Results publication: PubMed 33202890Douzi 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.
- Results publication: PubMed 34039509De 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.
- Results publication: PubMed 32354504Scheer 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.
- Results publication: PubMed 29685558Lin 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.
- Results publication: PubMed 28574942Finger 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.
- Derived from this study: PubMed 41832513Lanzetti RM, Giai Via A, Anzano F, Pipino G, Alonzo R, D'Arrigo C, De Sanctis S, Spoliti M, Fidone G, Migliorini F, Maffulli N. Third-generation cryotherapy reduces time to surgery and local complications in patients with ankle fractures: a prospective randomised controlled trial. J Orthop Surg Res. 2026 Mar 14;21(1):219. doi: 10.1186/s13018-025-06599-x.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennaro Pipino, M.D., Prof. study chair
San Raffaele University, Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Ankle Fractures, run by Azienda Ospedaliera San Camillo Forlanini at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to surgery (time frame: From enrollment to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06396364, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.