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

NCT01104831 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-08

No results posted yet for this study

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

Conditions

  • Proximal Tibia Fracture

Interventions

DEVICE

Cryotherapy

cooled sleeve placed over fracture site.

DEVICE

Room temperature cuff

sleeve with room temperature water placed over fracture site.

Sponsors & Collaborators

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Orthopedic Trauma Association

    collaborator UNKNOWN

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Jesse A Shantz, MD, MBA · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104831 on ClinicalTrials.gov