To Assess Rotation for Femoral Version and Tibial Torsion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Stephen Aoki, University of Utah
ClinicalTrials.gov Identifier:
NCT01531296
First received: February 8, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition
Rotational Malalignment of the Lower Extremity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Correlation Between MRI and Clinical Measurements of Lower Extremity Rotational Profile: Reliability of MRI to Assess Rotation for Femoral Version and Tibial Torsion

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To assess the inter/intra-observer reliability of rotational measurements on axial MRI images [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the correlation between clinical and MRI measures of femoral version and tibial torsion. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The objectives of this study are 1) to assess the inter/intra-observer reliability of rotational measurements on axial MRI images and 2) determine the correlation between clinical and MRI measures of femoral version and tibial torsion.

The investigators will use previously obtained MRI images to retrospectively calculate the inter-observer and intra-observer reliability of our measurements. Participating physicians will undergo training to standardize measurement technique. Five orthopaedic surgeons and one radiologist will perform the measurement to calculate inter-observer reliability. To asses intra-observer reliability, repeat measurements will be performed by the same physicians at a later date (at least 2 weeks). The physicians will be blinded to previous results when performing the second set of measurements. A standardized rotational profile will be performed on all patients presenting to the investigators with patellofemoral complaints or rotational abnormalities warranting intervention. Internal and external hip rotation will be measured in the prone and supine positions. Tibial torsion will be assessed with the thigh-foot axis in the prone and sitting positions. Investigators will participate in a formal training session prior to data collection to normalize measurements. Each study participant will undergo MRI imaging of the femur and tibia.

  Eligibility

Ages Eligible for Study:   8 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria: Retrospective:

  • 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.

Inclusion Criteria: Prospective:

  • 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

Exclusion Criteria: Retrospective:

  • Any patients with imaging studies insufficient to provide all of the required measurements and any patient previously surgically treated for rotational malalignment

Exclusion Criteria: Prospective:

  • Any patient that has undergone previous surgical treatments for rotational malalignment.
  • Any patients with implantable devices not compatible with MRI
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531296

Locations
United States, Utah
University of Utah Orthopaedic Center
Salt Lake, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Stephen Aoki, MD University of Utah Orthopaedic Center
  More Information

No publications provided

Responsible Party: Stephen Aoki, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01531296     History of Changes
Other Study ID Numbers: 51477
Study First Received: February 8, 2012
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
MRI
Lower Extremity Rotational
Femoral Version
Tibial Torsion

ClinicalTrials.gov processed this record on August 28, 2014