The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures (ARCTIC CAT)

May 3, 2017 updated by: University of Manitoba

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Winnipeg Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Skeletally mature
  • Trauma patients with single-system musculoskeletal injuries.
  • Proximal tibia fractures treated with open reduction and internal fixation.
  • Unilateral proximal tibial injuries.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 21 degree Cooling
Room temperature water circulated through cryotherapy sleeve.
Device: Room temperature cuff
sleeve with room temperature water placed over fracture site.
Active Comparator: 10 degree cooling
Cooled water circulated through a cryotherapy sleeve.
Device: Cryotherapy
cooled sleeve placed over fracture site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS Pain Score
Time Frame: 2 weeks
2 weeks
Narcotic Requirements
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Orthopedic Research and Education Foundation
Orthopedic Trauma Association

Investigators

  • Principal Investigator: Jesse A Shantz, MD, MBA, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2009:035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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