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

Primary Purpose

Proximal Tibia Fracture

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Cryotherapy
Room temperature cuff
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Tibia Fracture focused on measuring Tibial Plateau Fracture, AO/OTA 41

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Winnipeg Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

21 degree Cooling

10 degree cooling

Arm Description

Room temperature water circulated through cryotherapy sleeve.

Cooled water circulated through a cryotherapy sleeve.

Outcomes

Primary Outcome Measures

Cost

Secondary Outcome Measures

VAS Pain Score
Narcotic Requirements

Full Information

First Posted
April 14, 2010
Last Updated
May 3, 2017
Sponsor
University of Manitoba
Collaborators
Orthopedic Research and Education Foundation, Orthopedic Trauma Association
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1. Study Identification

Unique Protocol Identification Number
NCT01104831
Brief Title
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
Acronym
ARCTIC CAT
Official Title
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment.
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Orthopedic Research and Education Foundation, Orthopedic Trauma Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Tibia Fracture
Keywords
Tibial Plateau Fracture, AO/OTA 41

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
21 degree Cooling
Arm Type
Placebo Comparator
Arm Description
Room temperature water circulated through cryotherapy sleeve.
Arm Title
10 degree cooling
Arm Type
Active Comparator
Arm Description
Cooled water circulated through a cryotherapy sleeve.
Intervention Type
Device
Intervention Name(s)
Cryotherapy
Intervention Description
cooled sleeve placed over fracture site.
Intervention Type
Device
Intervention Name(s)
Room temperature cuff
Intervention Description
sleeve with room temperature water placed over fracture site.
Primary Outcome Measure Information:
Title
Cost
Time Frame
3 months
Secondary Outcome Measure Information:
Title
VAS Pain Score
Time Frame
2 weeks
Title
Narcotic Requirements
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse A Shantz, MD, MBA
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winnipeg Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

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