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Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610701
First received: January 25, 2008
Last updated: March 2, 2011
Last verified: March 2011
History of Changes

January 25, 2008
March 2, 2011
March 2006
March 2011   (final data collection date for primary outcome measure)
  • Quadriceps strength [ Time Frame: Post-op at 6 weeks, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: Post-op at 6 weeks, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610701 on ClinicalTrials.gov Archive Site
  • Musculoskeletal Function Assessment Injury and Arthritis Survey [ Time Frame: Admission, 6 weeks, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • SF-36 Health Survey [ Time Frame: Admission, 6 weeks, 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fractures, Closed
  • Device: Anterior pin placement
    Anteriorly-placed (front of the leg) femoral external fixator pins
  • Device: Lateral pin placement
    Laterally-placed (side of the leg) femoral external fixator pind
  • Experimental: 1
    Anterior
    Intervention: Device: Anterior pin placement
  • Experimental: 2
    Lateral
    Intervention: Device: Lateral pin placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2012
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Brett Crist, MD 573-882-3104 cristb@health.missouri.edu
United States
 
NCT00610701
IRB 1059937
No
Brett Crist, MD, University of Missouri
University of Missouri-Columbia
Not Provided
Principal Investigator: Brett Crist, MD University of Missouri-Columbia
University of Missouri-Columbia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP