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

Proximal Tibia Fracture Clinical Trial

— ARCTIC CAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01104831
• Other study ID #: B2009:035
• Status: Terminated
• Phase: Phase 3
• First received: April 14, 2010
• Last updated: May 3, 2017
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Proximal Tibia Fracture
• Tibial Fractures

Intervention

Device:
• Cryotherapy
cooled sleeve placed over fracture site.
• Room temperature cuff
sleeve with room temperature water placed over fracture site.

Locations

Country	Name	City	State
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Orthopedic Research and Education Foundation, Orthopedic Trauma Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost		3 months
Secondary	VAS Pain Score		2 weeks
Secondary	Narcotic Requirements		2 weeks