An observational study in Rotational Malalignment of the Lower Extremity, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 8 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by University of Utah · Observational
Determining the investigators ability to accurately assess rotational malalignment clinically compared to imaging.
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.
University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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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.
Inclusion Criteria: Retrospective:
Inclusion Criteria: Prospective:
Exclusion Criteria: Retrospective:
Exclusion Criteria: Prospective:
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
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Utah