Ankle FracturesNCT02498717
Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
A study testing GameReady and RICE in people with Ankle Fractures, run by AdventHealth at 1 site in United States.
Trial summary
This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- GameReady and RICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2015to 26 Jul 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Able to provide informed consent
- Recent calcaneus or ankle fracture requiring fixation
- Injury is determined (by physician) to be an isolated, closed, low-energy bimalleolar fracture
Who cannot join
- Unable to provide informed consent
- History of Dementia or mental instability
- No recent additional fractures (within one year) at or around injury site
- Persons with symptoms of any kind of psychosocial disorder
- Any condition that the clinician feels would contraindicate for the postoperative test or control treatments
- Any conditions that would contraindicate using the Game Ready
- If the patient is prevented from transfer to the OR due to reasons other than medically necessary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.
Read the detailed description
Initial research has shown that cryocompression therapy applied post-operatively has been effective in reducing recovery time and improving health and pain factors related to patient recovery. However, there has been limited research into how this translates into positive economic outcomes for both the hospital and the patient. In addition, it can be reasonably hypothesized that the use of the cryocompression therapy system before surgery will lead to an increased rate of reduction in swelling necessary to allow proper operative procedures to take place when compared to the standard ice and elevation (RICE) therapy techniques and cryocompression therapy applied only post-operatively. This should lead to decreased hospital costs and possible improved patient outcomes related to recovery.
Study Objectives This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.
- Conditions
- Ankle Fractures
- Being tested
- GameReady, RICE
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GameReadyDevice
Cryotherapy and compression
RICEOther
SOC ice and elevation
| Study group | Role | What they receive |
|---|---|---|
| RICE (control) | Active comparator | Standard of Care procedures including ice and elevation. Receives: Other: RICE |
| Cryocompression (experimental) | Experimental | treatment using the GameReady cryotherapy system Receives: Device: GameReady |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until surgery/Time until discharge (LOS)
Reduction in length of stay (LOS) and time of effect (pre-/post-op)
Measured: Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.
Change in Swelling as measured by point of largest swollen area (tape measure)
Measured at circumference of swelling point
Measured: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
reported as yes/no and amount/type on assessment form
Measured: Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Change in Patient reported pain as measured on VAS and Knee Pain Assessment
As reported by VAS scale
Measured: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Secondary outcomes (1)
Change in Quality of Life (QALY) as measured on QOL and SF-8
Quality of Life by QALY score
Measured: At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study start3 Jun 2015
- Primary completion9 Feb 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Cool Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian Vickaryous, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498717
- Sponsor's protocol ID
- 539147
- Status last verified
- Feb 2018
- First submitted
- 31 Mar 2015
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
- ClinicalTrials.gov ID
- NCT02498717
- Acronym / sponsor ID
- 539147
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Cool Systems, Inc.
- Study start
- 3 Jun 2015 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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.
This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.
Detailed description
Initial research has shown that cryocompression therapy applied post-operatively has been effective in reducing recovery time and improving health and pain factors related to patient recovery. However, there has been limited research into how this translates into positive economic outcomes for both the hospital and the patient. In addition, it can be reasonably hypothesized that the use of the cryocompression therapy system before surgery will lead to an increased rate of reduction in swelling necessary to allow proper operative procedures to take place when compared to the standard ice and elevation (RICE) therapy techniques and cryocompression therapy applied only post-operatively. This should lead to decreased hospital costs and possible improved patient outcomes related to recovery.
Study Objectives This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RICE (control) | Active comparator | Other: RICEStandard of Care procedures including ice and elevation. |
| Cryocompression (experimental) | Experimental | Device: GameReadytreatment using the GameReady cryotherapy system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Able to provide informed consent
- Recent calcaneus or ankle fracture requiring fixation
- Injury is determined (by physician) to be an isolated, closed, low-energy bimalleolar fracture
Key exclusion criteria (7 listed)
- Unable to provide informed consent
- History of Dementia or mental instability
- No recent additional fractures (within one year) at or around injury site
- Persons with symptoms of any kind of psychosocial disorder
- Any condition that the clinician feels would contraindicate for the postoperative test or control treatments
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 |
|---|---|---|
| GameReadyCryotherapy and compression | Device | Cryocompression (experimental) |
| RICESOC ice and elevation | Other | RICE (control) |
Primary outcome
Time until surgery/Time until discharge (LOS)
Time frame: Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.
Reduction in length of stay (LOS) and time of effect (pre-/post-op)
Change in Swelling as measured by point of largest swollen area (tape measure)
Time frame: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Measured at circumference of swelling point
Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
Time frame: Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
reported as yes/no and amount/type on assessment form
Change in Patient reported pain as measured on VAS and Knee Pain Assessment
Time frame: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
As reported by VAS scale
1 secondary outcome
Change in Quality of Life (QALY) as measured on QOL and SF-8
Time frame: At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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 15 Feb 2018.
Related trials for Ankle Fractures
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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.
Brian Vickaryous, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GameReady and RICE in people with Ankle Fractures, run by AdventHealth at 1 site in United States.
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 4 inclusion and 7 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 until surgery/Time until discharge (LOS) (time frame: Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2018.