To Assess Rotation for Femoral Version and Tibial Torsion
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|ClinicalTrials.gov Identifier: NCT01531296|
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : January 14, 2016
|Condition or disease|
|Rotational Malalignment of the Lower Extremity|
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.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
- To assess the inter/intra-observer reliability of rotational measurements on axial MRI images [ Time Frame: 4 years ]
- To determine the correlation between clinical and MRI measures of femoral version and tibial torsion. [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531296
|United States, Utah|
|University of Utah Orthopaedic Center|
|Salt Lake, Utah, United States, 84108|
|Principal Investigator:||Stephen Aoki, MD||University of Utah Orthopaedic Center|