The Efficacy and Cost Effectiveness of Preoperative and P... | NCT01104831

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

NCT01104831

Sponsor

University of Manitoba

Status

Terminated

Last Update Posted

May 8, 2017Actual

Enrollment

20Actual

Phase

Phase 3

Conditions

Proximal Tibia Fracture

Interventions

Cryotherapy
Room temperature cuff

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inadequate recruitment.

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Apr 14, 2010

First Submission Date that Met QC Criteria

Apr 14, 2010

First Posted Date

Apr 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2017

Last Update Posted Date

May 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of ManitobaOTHER

Collaborators

Name	Class
Orthopedic Research and Education Foundation	OTHER
Orthopedic Trauma Association	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cryotherapy	Device	cooled sleeve placed over fracture site.	10 degree cooling

Measure	Description	Time Frame
Cost		3 months

Measure	Description	Time Frame
VAS Pain Score		2 weeks
Narcotic Requirements		2 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesse A Shantz, MD, MBA	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Winnipeg Health Sciences Centre		Winnipeg	Manitoba	R3A 1R9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000092463	Tibial Plateau Fractures

Ancestor Terms

ID	Term
D000092443	Knee Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D013978	Tibial Fractures

Browse Leaves

Not provided

Browse Branches

Not provided