Proximal Tibia FracturePhase 3ARCTIC CATNCT01104831
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
A Phase 3 study testing Cryotherapy and Room temperature cuff in people with Proximal Tibia Fracture, run by University of Manitoba at 1 site in Canada.
Trial summary
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored. Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Proximal Tibia Fracture
- What is being tested?
- Cryotherapy and Room temperature cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Nov 2012
- Phase
- Phase 3
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Skeletally mature
- Trauma patients with single-system musculoskeletal injuries.
- Proximal tibia fractures treated with open reduction and internal fixation.
- Unilateral proximal tibial injuries.
Who cannot join
- Previous ipsilateral knee surgery
- Upper extremity injuries impairing mobilization
- Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
- Associated injuries impairing mobilization
- Suspected or confirmed compartment syndrome
- Open fractures
- Patients previously on narcotics
- Patients with impaired sensorium Concurrent head injury Intoxication
Trial locations and contacts
1 site in 1 country.
About this study
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.
Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement
- Conditions
- Proximal Tibia Fracture
- Being tested
- Cryotherapy, Room temperature cuff
- Keywords
- Tibial Plateau Fracture, AO/OTA 41
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
cooled sleeve placed over fracture site.
Room temperature cuffDevice
sleeve with room temperature water placed over fracture site.
| Study group | Role | What they receive |
|---|---|---|
| 21 degree Cooling | Placebo comparator | Room temperature water circulated through cryotherapy sleeve. Receives: Device: Room temperature cuff |
| 10 degree cooling | Active comparator | Cooled water circulated through a cryotherapy sleeve. Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost
Measured: 3 months
Secondary outcomes (2)
VAS Pain Score
Measured: 2 weeks
Narcotic Requirements
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionNov 2012
Why it stopped: Inadequate recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Tibia FractureStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Orthopedic Trauma Association
- Investigators
- Jesse A Shantz, MD, MBA, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104831
- Sponsor's protocol ID
- B2009:035
- Acronym
- ARCTIC CAT
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2010
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
- ClinicalTrials.gov ID
- NCT01104831
- Acronym / sponsor ID
- ARCTIC CAT / B2009:035
- Conditions
- Proximal Tibia Fracture
- Keywords
- Tibial Plateau Fracture, AO/OTA 41
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Orthopedic Trauma Association
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Apr 2010 (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.
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.
Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 21 degree Cooling | Placebo comparator | Device: Room temperature cuffRoom temperature water circulated through cryotherapy sleeve. |
| 10 degree cooling | Active comparator | Device: CryotherapyCooled water circulated through a cryotherapy sleeve. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletally mature
- Trauma patients with single-system musculoskeletal injuries.
- Proximal tibia fractures treated with open reduction and internal fixation.
- Unilateral proximal tibial injuries.
Key exclusion criteria (8 listed)
- Previous ipsilateral knee surgery
- Upper extremity injuries impairing mobilization
- Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
- Associated injuries impairing mobilization
- Suspected or confirmed compartment syndrome
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 |
|---|---|---|
| Cryotherapycooled sleeve placed over fracture site. | Device | 10 degree cooling |
| Room temperature cuffsleeve with room temperature water placed over fracture site. | Device | 21 degree Cooling |
Primary outcome
Cost
Time frame: 3 months
2 secondary outcomes
VAS Pain Score
Time frame: 2 weeks
Narcotic Requirements
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Inadequate recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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.
Jesse A Shantz, MD, MBA principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cryotherapy and Room temperature cuff in people with Proximal Tibia Fracture, run by University of Manitoba at 1 site in Canada.
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 8 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: stopped early, as of the sponsor's last update on 8 May 2017. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inadequate recruitment.). Results are not available in the source record.
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?
Cost (time frame: 3 months). 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 8 May 2017.