Femoroacetabular ImpingementNCT02260726
Evaluation of Ultrasound for Detecting Hip Impingement
A study testing Magnetic resonance imaging and Ultrasound in people with Femoroacetabular Impingement, run by Ottawa Hospital Research Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Magnetic resonance imaging and Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients who don't meet inclusion criteria
- Control group: subjects with hip pain or with alpha angle > 50 degrees on MRI
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Magnetic resonance imaging, Ultrasound
- Keywords
- femoroacetabular impingement, morphometry, dynamic, magnetic resonance imaging, ultrasound, screening, diagnosis
- Medical subject headings
- Femoracetabular Impingement, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingProcedure or surgery
UltrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | 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. Receives: Procedure: Magnetic resonance imaging; Procedure: Ultrasound |
| Control | Other | Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging. Receives: Procedure: Magnetic resonance imaging; Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound grade
Ultrasound grade evaluated on a four point scale following ultrasound imaging session
Measured: Upon enrollment
Secondary outcomes (2)
Ultrasound parameters
Morphometry of hip measured in ultrasound images: alpha angle, clearance angle
Measured: Upon enrollment
MRI parameters
Standard MRI measures of impingement from images. Used as gold standard for comparative purposes.
Measured: Upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014 (estimated)
- Primary completionOct 2015 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: No funding available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul E Beaule, MD, FRCSC, Principal investigator, University of Ottawa / The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260726
- Sponsor's protocol ID
- 20140318-01H
- Status last verified
- Apr 2018
- First submitted
- 6 Oct 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Deformities of the Hip Associated With Arthritis: MRI vs Ultrasound
- ClinicalTrials.gov ID
- NCT02260726
- Acronym / sponsor ID
- 20140318-01H
- Conditions
- Femoroacetabular Impingement
- Keywords
- femoroacetabular impingement, morphometry, dynamic, magnetic resonance imaging, ultrasound, screening, diagnosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Oct 2014 (estimated)
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: Magnetic resonance imaging, Procedure: UltrasoundSubjects 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. |
| Control | Other | Procedure: Magnetic resonance imaging, Procedure: UltrasoundAsymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Hip pain longer than 6 months referred to the groin/lateral aspect of the hip
- Positive Impingement Sign
- 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.
Key exclusion criteria (2 listed)
- Patients who don't meet inclusion criteria
- Control group: subjects with hip pain or with alpha angle > 50 degrees on MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging | Procedure or surgery | Control, Surgical group |
| Ultrasound | Procedure or surgery | Control, Surgical group |
Primary outcome
Ultrasound grade
Time frame: Upon enrollment
Ultrasound grade evaluated on a four point scale following ultrasound imaging session
2 secondary outcomes
Ultrasound parameters
Time frame: Upon enrollment
MRI parameters
Time frame: Upon enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E Beaule, MD, FRCSC principal investigator
University of Ottawa / The Ottawa Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging and Ultrasound in people with Femoroacetabular Impingement, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound grade (time frame: Upon enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.