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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Orthopedic Research and Education Foundation
Orthopedic Trauma Association
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01104831
First received: April 14, 2010
Last updated: April 4, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Proximal Tibia Fracture
Device: Cryotherapy
Device: Room temperature cuff
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cost [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS Pain Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Narcotic Requirements [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: April 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104831

Locations
Canada, Manitoba
Winnipeg Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Jesse A Shantz, MD, MBA    (204) 787-4217    jshantz2@gmail.com   
Contact: Danny Gillis, MD    (204) 787-4217    drdgillis@gmail.com   
Sponsors and Collaborators
University of Manitoba
Orthopedic Research and Education Foundation
Orthopedic Trauma Association
Investigators
Principal Investigator: Jesse A Shantz, MD, MBA University of Manitoba
  More Information

No publications provided

Responsible Party: Jesse Shantz, University of Manitoba
ClinicalTrials.gov Identifier: NCT01104831     History of Changes
Other Study ID Numbers: B2009:035
Study First Received: April 14, 2010
Last Updated: April 4, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Tibial Plateau Fracture
AO/OTA 41

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 27, 2014