Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

Not Applicable

Terminated

• Conditions: Fractures, Closed
• Interventions: Device: Lateral pin placement; Device: Anterior pin placement

• Registration Number: NCT00610701
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

The purpose of this study is to evaluate patients with tibial plateau fractures.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2012-08
• Study Completion: 2014-02
• Results First Submitted: 2014-04-10
• Results First Submitted QC: 2014-09-03
• Results First Posted: 2014-09-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral pin placement	Lateral pin placement	Lateral pin placement
Anterior pin placement	Anterior pin placement	Anterior pin placement

Primary Outcome Measures

Name	Time	Method
Quadriceps Strength	(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

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States