Evaluation of Ultrasound for Detecting Hip Impingement

April 13, 2018 updated by: Ottawa Hospital Research Institute

Diagnosing Deformities of the Hip Associated With Arthritis: MRI vs Ultrasound

Patients are being asked to participate in this study because a previous research MRI of their hips showed that the shape of the head of their thigh bone may indicate FAI of the hip. We have already collected cartilage imaging data and data on how the hip joint moves on people with painful/symptomatic FAI and people with normal hip function. We would now like to compare the motion of the hip joint to those with painful FAI using ultrasound.

Study Overview

Detailed Description

Hip impingement is thought to be a leading cause of hip osteoarthritis, and occurs due to deformities in the hip joint. However some individuals have these deformities but do not exhibit symptoms. Using the standard magnetic resonance imaging and clinical tests it is not clear which deformities will cause degeneration, requiring surgical intervention. We propose to evaluate the deformity and impingement between the femur and acetabulum using dynamic ultrasound imaging. Ultrasound does not involve radiation and can acquire video of the hip joint and is thus suitable for such diagnostic purposes. In this pilot study we will evaluate the feasibility of ultrasound in diagnosing hip impingement.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Surgical group:

  • Hip pain longer than 6 months referred to the groin/lateral aspect of the hip
  • Positive Impingement Sign

Plain radiographs:

  • Absence of arthritis (Tonnis Grade 0 or 1)
  • Absence of dysplasia (center edge >25 degrees) on anterior-posterior radiograph
  • α-angle greater than 60 degrees on MRI.

Exclusion Criteria:

  • Patients who don't meet inclusion criteria
  • Control group: subjects with hip pain or with alpha angle > 50 degrees on MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical group
Subjects already scheduled to undergo surgical correction of a symptomatic cam-type hip impingement deformity. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound investigation prior to surgery.
Other: Control
Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound grade
Time Frame: Upon enrollment
Ultrasound grade evaluated on a four point scale following ultrasound imaging session
Upon enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound parameters
Time Frame: Upon enrollment
Morphometry of hip measured in ultrasound images: alpha angle, clearance angle
Upon enrollment
MRI parameters
Time Frame: Upon enrollment
Standard MRI measures of impingement from images. Used as gold standard for comparative purposes.
Upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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