Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

Fractures, Closed Clinical Trial

Official title:

Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00610701
• Other study ID #: IRB 1059937
• Status: Terminated
• Phase: N/A
• First received: January 25, 2008
• Last updated: June 16, 2017
• Start date: March 2006
• Est. completion date: February 2014

Study information

• Verified date: June 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: February 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Closed

Intervention

Device:
• Anterior pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
• Lateral pin placement
Laterally-placed (side of the leg) femoral external fixator pind

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps Strength	measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose	(admission, 6 weeks, 3 months, 6 months) 1 year