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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:
ClinicalTrials.gov Identifier:
NCT00610701
First Posted: February 8, 2008
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
  Purpose
The purpose of this study is to evaluate patients with tibial plateau fractures.

Condition Intervention
Fractures, Closed Device: Anterior pin placement Device: Lateral pin placement

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brett Crist, University of Missouri-Columbia:

Primary Outcome Measures:
  • 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


Enrollment: 35
Study Start Date: March 2006
Study Completion Date: February 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Brett Crist, MD University of Missouri-Columbia
  More Information

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     History of Changes
Other Study ID Numbers: IRB 1059937
First Submitted: January 25, 2008
First Posted: February 8, 2008
Results First Submitted: April 10, 2014
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:
Fractures, Bone
Fractures, Closed
Wounds and Injuries