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

Phase 3TerminatedNCT01104831

University of Manitoba20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Proximal Tibia Fracture

Interventions

CryotherapyDEVICE

cooled sleeve placed over fracture site.

Room temperature cuffDEVICE

sleeve with room temperature water placed over fracture site.

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Cost

Time frame: 3 months

Secondary Outcomes

VAS Pain Score

Time frame: 2 weeks

Narcotic Requirements

Time frame: 2 weeks

Data from ClinicalTrials.gov

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