Columbia, Missouri 65212


Purpose:

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.


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


Study is Available At:


Original ID:

IRB 1059937


NCT ID:

NCT00610701


Secondary ID:


Study Acronym:


Brief Title:

Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures


Official Title:

Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Brett Crist, MD
Principal Investigator
University of Missouri-Columbia
Primary Contact:Brett Crist, MD
573-882-3104
cristb@health.missouri.edu

Study Dates

Start Date:March 2006
Completion Date:April 2014
Completion Type:Anticipated
Primary Completion Date:December 2013
Primary Completion Type:Anticipated
Verification Date:December 2013
Last Changed Date:December 20, 2013
First Received Date:January 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Quadriceps strength
Time Frame:Post-op at 6 weeks, 3 months, 6 months, and 1 year
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Range of Motion
Time Frame:Post-op at 6 weeks, 3 months, 6 months, and 1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Musculoskeletal Function Assessment Injury and Arthritis Survey
Time Frame:Admission, 6 weeks, 3 months, 6 months, and 1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:SF-36 Health Survey
Time Frame:Admission, 6 weeks, 3 months, 6 months, and 1 year
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Anterior pin placement
Description:Anteriorly-placed (front of the leg) femoral external fixator pins
Arm Name:1
Intervention Type:Device
Name:Lateral pin placement
Description:Laterally-placed (side of the leg) femoral external fixator pind
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Anterior
Study Arm Type:Experimental
Arm Name:2
Description:Lateral

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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