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Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

This study has been terminated.
(Extremely low enrollment and very little follow-up for meaningful data)
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610701
First received: January 25, 2008
Last updated: June 16, 2017
Last verified: June 2017
January 25, 2008
June 16, 2017
March 2006
August 2012   (Final data collection date for primary outcome measure)
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
  • Quadriceps Strength [ Time Frame: Post-op at 6 weeks, 3 months, 6 months, and 1 year ]
  • Range of Motion [ Time Frame: Post-op at 6 weeks, 3 months, 6 months, and 1 year ]
Complete list of historical versions of study NCT00610701 on ClinicalTrials.gov Archive Site
Not Provided
  • Musculoskeletal Function Assessment Injury and Arthritis Survey [ Time Frame: Admission, 6 weeks, 3 months, 6 months, and 1 year ]
  • SF-36 Health Survey [ Time Frame: Admission, 6 weeks, 3 months, 6 months, and 1 year ]
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 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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: Anterior pin placement
    Anterior pin placement
    Intervention: Device: Anterior pin placement
  • Experimental: Lateral pin placement
    Lateral pin placement
    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.
 
Terminated
35
February 2014
August 2012   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00610701
IRB 1059937
No
Not Provided
No
Not Provided
Brett Crist, University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Brett Crist, MD University of Missouri-Columbia
University of Missouri-Columbia
June 2017

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