Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

This study is currently recruiting participants.
Verified December 2013 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610701
First received: January 25, 2008
Last updated: December 20, 2013
Last verified: December 2013
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Anterior
Device: Anterior pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
Experimental: 2
Lateral
Device: Lateral pin placement
Laterally-placed (side of the leg) femoral external fixator pind

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610701

Contacts
Contact: Brett Crist, MD 573-882-3104 cristb@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Sub-Investigator: Gregory J Della Rocca, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Brett Crist, MD University of Missouri-Columbia
  More Information

No publications provided

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
Study First Received: January 25, 2008
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014