Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Assess Rotation for Femoral Version and Tibial Torsion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531296
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Stephen Aoki, University of Utah

Tracking Information
First Submitted Date February 8, 2012
First Posted Date February 10, 2012
Last Update Posted Date January 14, 2016
Study Start Date October 2011
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2013)
To assess the inter/intra-observer reliability of rotational measurements on axial MRI images [ Time Frame: 4 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2013)
To determine the correlation between clinical and MRI measures of femoral version and tibial torsion. [ Time Frame: 4 years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Assess Rotation for Femoral Version and Tibial Torsion
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Rotational Malalignment of the Lower Extremity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2016)
37
Original Estimated Enrollment
 (submitted: February 8, 2012)
50
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01531296
Other Study ID Numbers 51477
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stephen Aoki, University of Utah
Study Sponsor University of Utah
Collaborators Not Provided
Investigators
Principal Investigator: Stephen Aoki, MD University of Utah Orthopaedic Center
PRS Account University of Utah
Verification Date January 2016