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OpenTrials
Completed

NCT Number: NCT01531296

To Assess Rotation for Femoral Version and Tibial Torsion

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

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Key information

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 4 years

Secondary outcomes

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

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Correlation Between MRI and Clinical Measurements of Lower Extremity Rotational Profile: Reliability of MRI to Assess Rotation for Femoral Version and Tibial Torsion

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2012
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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