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Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

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ClinicalTrials.gov Identifier: NCT00610701
Recruitment Status : Terminated (Extremely low enrollment and very little follow-up for meaningful data)
First Posted : February 8, 2008
Results First Posted : September 10, 2014
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

Study Description
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Brief Summary:
The purpose of this study is to evaluate patients with tibial plateau fractures.

Condition or disease Intervention/treatment Phase
Fractures, Closed Device: Anterior pin placement Device: Lateral pin placement Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Study Start Date : March 2006
Actual Primary Completion Date : August 2012
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anterior pin placement
Anterior pin placement
 Device: Anterior pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
Experimental: Lateral pin placement
Lateral pin placement
 Device: Lateral pin placement
Laterally-placed (side of the leg) femoral external fixator pind


Outcome Measures
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Primary Outcome Measures :
  1. Quadriceps Strength [ Time Frame: (admission, 6 weeks, 3 months, 6 months) 1 year ]
    measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610701


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Brett Crist, MD University of Missouri-Columbia
More Information
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Responsible Party: Brett Crist, Associate Professor, Co-Director of Trauma Services, Co-Director of Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00610701    
Other Study ID Numbers: IRB 1059937
First Posted: February 8, 2008    Key Record Dates
Results First Posted: September 10, 2014
Last Update Posted: July 24, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries