The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
Phase 3
Terminated
- Conditions
- Proximal Tibia Fracture
- Interventions
- Device: Room temperature cuffDevice: Cryotherapy
- Registration Number
- NCT01104831
- Lead Sponsor
- University of Manitoba
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 21 degree Cooling Room temperature cuff Room temperature water circulated through cryotherapy sleeve. 10 degree cooling Cryotherapy Cooled water circulated through a cryotherapy sleeve.
- Primary Outcome Measures
Name Time Method Cost 3 months
- Secondary Outcome Measures
Name Time Method VAS Pain Score 2 weeks Narcotic Requirements 2 weeks
Trial Locations
- Locations (1)
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada