- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260726
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
Status
Withdrawn
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20140318-01H
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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