To Assess Rotation for Femoral Version and Tibial Torsion

NCT ID: NCT01531296

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-11-30

Brief Summary

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

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.

Conditions

Rotational Malalignment of the Lower Extremity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Stephen Aoki

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Aoki, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopaedic Center

Locations

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

51477

Identifier Type: -

Identifier Source: org_study_id