Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Primary Purpose
Fractures, Closed
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior pin placement
Lateral pin placement
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Closed
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and above (adult population)
- All open and closed tibial plateau fractures
Exclusion Criteria:
- 17 years of age and less (pediatric population)
- Quadriplegic patients
- Vascular Injury to Extremity
- Ipsilateral femur fractures
- Ipsilateral Hip fractures
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Anterior pin placement
Lateral pin placement
Arm Description
Anterior pin placement
Lateral pin placement
Outcomes
Primary Outcome Measures
Quadriceps Strength
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
Secondary Outcome Measures
Full Information
NCT ID
NCT00610701
First Posted
January 25, 2008
Last Updated
June 22, 2017
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00610701
Brief Title
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Official Title
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Extremely low enrollment and very little follow-up for meaningful data
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate patients with tibial plateau fractures.
Detailed Description
The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.
Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Closed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior pin placement
Arm Type
Experimental
Arm Description
Anterior pin placement
Arm Title
Lateral pin placement
Arm Type
Experimental
Arm Description
Lateral pin placement
Intervention Type
Device
Intervention Name(s)
Anterior pin placement
Intervention Description
Anteriorly-placed (front of the leg) femoral external fixator pins
Intervention Type
Device
Intervention Name(s)
Lateral pin placement
Intervention Description
Laterally-placed (side of the leg) femoral external fixator pind
Primary Outcome Measure Information:
Title
Quadriceps Strength
Description
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
Time Frame
(admission, 6 weeks, 3 months, 6 months) 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and above (adult population)
All open and closed tibial plateau fractures
Exclusion Criteria:
17 years of age and less (pediatric population)
Quadriplegic patients
Vascular Injury to Extremity
Ipsilateral femur fractures
Ipsilateral Hip fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Crist, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
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