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Clinical Trials/NCT01104831
NCT01104831
Terminated
Phase 3

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

University of Manitoba1 site in 1 country20 target enrollmentApril 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Proximal Tibia Fracture
Sponsor
University of Manitoba
Enrollment
20
Locations
1
Primary Endpoint
Cost
Status
Terminated
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
November 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Cost

Time Frame: 3 months

Secondary Outcomes

  • VAS Pain Score(2 weeks)
  • Narcotic Requirements(2 weeks)

Study Sites (1)

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