NCT01104831

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 8, 2017

Status Verified

April 1, 2011

Enrollment Period

2.3 years

First QC Date

April 14, 2010

Last Update Submit

May 3, 2017

Conditions

Proximal Tibia Fracture

Keywords

Tibial Plateau FractureAO/OTA 41

Outcome Measures

Primary Outcomes (1)

  • Cost

    3 months

Secondary Outcomes (2)

  • VAS Pain Score

    2 weeks

  • Narcotic Requirements

    2 weeks

Study Arms (2)

21 degree Cooling

PLACEBO COMPARATOR

Room temperature water circulated through cryotherapy sleeve.

Device: Room temperature cuff

10 degree cooling

ACTIVE COMPARATOR

Cooled water circulated through a cryotherapy sleeve.

Device: Cryotherapy

Interventions

CryotherapyDEVICE

cooled sleeve placed over fracture site.

10 degree cooling
Room temperature cuffDEVICE

sleeve with room temperature water placed over fracture site.

21 degree Cooling

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature
  • Trauma patients with single-system musculoskeletal injuries.
  • Proximal tibia fractures treated with open reduction and internal fixation.
  • Unilateral proximal tibial injuries.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jesse A Shantz, MD, MBA

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 16, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

May 8, 2017

Record last verified: 2011-04

Locations

CA(1)