To Assess Rotation for Femoral Version and Tibial Torsion

NCT01531296 | Completed

• 1 other identifier: 51477
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Determining the investigators ability to accurately assess rotational malalignment clinically compared to imaging.

Conditions

Rotational Malalignment of the Lower Extremity

Keywords

MRI; Lower Extremity Rotational; Femoral Version; Tibial Torsion

Outcome Measures

Primary Outcomes (1)

• To assess the inter/intra-observer reliability of rotational measurements on axial MRI images

  4 years

Secondary Outcomes (1)

• To determine the correlation between clinical and MRI measures of femoral version and tibial torsion.

  4 years

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study is aiming to recruit all patients with complaints of patellofemoral pain/instability associated with rotational malalignment. The two types of rotational malalignment, fibial version and tibial torsion are most common among the pediatric population.

You may qualify if:

• Prior study MRI images available in the University PACS system
• Prior study MRI images obtained at PCMC and uploaded into the OsiriX software (OsiriX is a software program compatible with multiple imaging formats that has easily adaptable measurement tools)
• We will search our imaging database from 2009 to current. Included will be all gun site MRI studies obtained at PCMC or the UOC for evaluation of rotational profile. We will exclude any study in which images are not sufficient to obtain all of the required measurements needed for our study. A preliminary review of the imaging database has identified 42 potential studies. Our power analysis calls for 15 patients to be included to obtain a 95% confidence interval.
• All patients of the investigating physicians, male and female, between the ages of 8 and 30 presenting with complaints of patellofemoral pain/instability or rotational abnormality
• All patients with neuromuscular disease, including cerebral palsy

You may not qualify if:

• Any patients with imaging studies insufficient to provide all of the required measurements and any patient previously surgically treated for rotational malalignment
• Any patient that has undergone previous surgical treatments for rotational malalignment.
• Any patients with implantable devices not compatible with MRI

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

• Stephen Aoki, MD

  University of Utah Orthopaedic Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)