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

University of Manitoba

Status and phase: Terminated; Phase 3

Conditions: Proximal Tibia Fracture

Treatments: Device: Cryotherapy; Device: Room temperature cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT01104831

B2009:035

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

21 degree Cooling

Placebo Comparator group

Description:

Room temperature water circulated through cryotherapy sleeve.

Treatment:

Device: Room temperature cuff

10 degree cooling

Active Comparator group

Description:

Cooled water circulated through a cryotherapy sleeve.

Treatment:

Device: Cryotherapy