NCT01104831
Terminated
Phase 3
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
ConditionsProximal Tibia Fracture
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
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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