Back to resultsSplinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Primary Purpose
Tibia Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Post-Op Splinting
No Splinting
Sponsored by
About this trial
This is an interventional treatment trial for Tibia Fracture
Eligibility Criteria
Inclusion Criteria:
- Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail
Exclusion Criteria:
- Pregnant Women
- Prisoners
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Splinting
2. No Splinting
Arm Description
Outcomes
Primary Outcome Measures
Differences across time and between groups for pain and range of motion
Secondary Outcome Measures
Full Information
NCT ID
NCT00888550
First Posted
April 23, 2009
Last Updated
September 28, 2010
Sponsor
Denver Health and Hospital Authority
1. Study Identification
Unique Protocol Identification Number
NCT00888550
Brief Title
Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Official Title
A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Denver Health and Hospital Authority
4. Oversight
5. Study Description
Brief Summary
Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience.
The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibia Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1. Splinting
Arm Type
Experimental
Arm Title
2. No Splinting
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Post-Op Splinting
Intervention Description
Splint will applied post-operatively and will remain on for two weeks
Intervention Type
Procedure
Intervention Name(s)
No Splinting
Intervention Description
Patient will be discharged post-operatively without a splint on their lower leg.
Primary Outcome Measure Information:
Title
Differences across time and between groups for pain and range of motion
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail
Exclusion Criteria:
Pregnant Women
Prisoners
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures
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