Femoroacetabular ImpingementNCT01546493
Hip Impingement - Understanding Cartilage Damage
A study testing MRI, qCT and Motion Analysis in people with Femoroacetabular Impingement, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics and joint degradation to better identify 'at-risk' patients requiring corrective surgery will be scrutinized to gain a better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- MRI, qCT and Motion Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2010to 28 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group I: Subjects with bilateral cam deformity and unilateral symptoms; Hip pain longer than 6 months referred to the groin/lateral aspect of hip; Positive impingement sign (determined by the surgeon); Plain radiographs: absence of arthritis (Tonnis Grade 0 or 1), absence of dysplasia (center edge >25 degrees) on AP radiograph, α-angle greater than 55 degrees on the Dunn view.
- Group II: Asymptomatic subjects with cam deformity; These patients will be recruited from our prevalence study (2006.813) with 200 asymptomatic individuals using MRI with radial sequences.
- Group III: Asymptomatic control subjects with no deformity; These patients will be recruited from our prevalence study (2006.813) which established their hip joint as having a normal femoral head neck contour. These subjects will be age-matched to Group I.
Who cannot join
- Participants who do not meet the criteria above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoroacetabular Impingement: Correlating Hip Morphology to Changes in Cartilage and Subchondral Bone
Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics and joint degradation to better identify 'at-risk' patients requiring corrective surgery will be scrutinized to gain a better understanding of the condition's natural history. The influence of certain morphologies (e.g. size and location of the deformity) will be analyzed to determine if this leads to aberrant loading of regions of the cartilage and subchondral bone, resulting in cartilage damage and joint degradation. Additionally, this research will determine if changes in the subchondral bone precede cartilage degeneration.
The methodology for establishing the morphology/cartilage degeneration relationship includes Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer simulation/finite element analysis.
The outcomes of this research may lead to a reduction in total hip replacement cases by as much as 70%, saving many Canadians from a painful and debilitating condition and reducing costs to the Canadian health care system by as much as $290 million annually.
Read the detailed description
The research objectives are:
- To determine the factors of cam deformities, including morphological, functional and bone quality, that are associated with cartilage degeneration through shape analysis, kinematic analysis, MRI imaging and bone densitometry.
- To determine whether subchondral bone changes occur before detectable cartilage degeneration by examining magnetic resonance images of asymptomatic subjects who have an identifiable deformity.
- To use 3D motion and finite element analysis to examine differences in mechanical stimuli in the subchondral bone and cartilage that are associated with FAI, thus expanding our understanding of the pathomechanisms of associated degeneration.
Three subject cohorts will be recruited: subjects with bilateral cam deformity and unilateral symptoms (Group I, 'active cartilage damage stage'), asymptomatic subjects with cam deformity (Group II, 'early stage') and asymptomatic control subjects with no deformity (Group III).
- Conditions
- Femoroacetabular Impingement
- Being tested
- MRI, qCT, Motion Analysis, PET-MRI
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
MRI scan. 3.0 Tesla MRI scans of both hips using Tip(T1-rho) and ultra-short echo time (UTE) sequences.
qCTRadiation
Quantitative computed tomography(QCT) scans using a CT phantom
Motion AnalysisOther
3D motion analysis to assess hip function.
PET-MRIRadiation
Also called Positron emission tomography-magnetic resonance imaging
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will help us examine bone and cartilage at the molecular level.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Experimental | Asymptomatic control subjects with no deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Receives: Radiation: MRI; Radiation: qCT; Other: Motion Analysis |
| Symptomatics | Experimental | Subjects with bilateral cam deformity and unilateral symptoms. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa. Receives: Radiation: MRI; Radiation: qCT; Other: Motion Analysis; Radiation: PET-MRI |
| Asymptomatic | Experimental | Asymptomatic subjects with cam deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa. Receives: Radiation: MRI; Radiation: qCT; Other: Motion Analysis; Radiation: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI)
Patients will undergo MRI modalities which are sensitive to biochemical markers (T1-rho) and bone porosity (ultra-short echo time [UTE]) to evaluate joint cartilage. The T1-rho imaging is used to detect early molecular and biochemical alterations to cartilage while the UTE imaging is used to assess bone porosity. MRI scans will be completely pre-operatively and at a minimum of 24 months post-operatively.
Measured: 24 months
Secondary outcomes (3)
Quantitative Computed Tomography (qCT)
Patients will undergo a CT scan of the hip (qCT) that is sensitive to the mineral content within bone tissue, and can assess bone mineral density, a strong predictor of bone strength and stiffness, which can influence the health of the cartilage. This scan will take approximately 15 minutes.
Measured: 24 months
Quantitative Motion Analysis to assess hip joint function
Hip joint kinematics and contact forces will be analyzed in the same subjects undergoing imaging analysis to better understand the role of joint function in the degeneration process. Patients will have 16 pairs of surface electromyography (EMG) electrodes placed on certain area of the skin. The kinematic and kinetic data will be recorded for all 3 groups. Data will be recorded during normal level walking and during completion of simulated daily tasks (uphill, downhill walking, stairs, squatting, sitting, rising from a chair).
Measured: 24 months
Positron emission tomography-magnetic resonance imaging (PET-MRI)
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will examine bone and cartilage at the molecular level.
Measured: 24 months or greater after original enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study start4 Aug 2010
- Primary completion28 Apr 2024 (estimated)
- Study completion28 Apr 2024 (estimated)
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Paul E Beaule, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546493
- Sponsor's protocol ID
- 2009537
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2010
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoroacetabular Impingement: Correlating Hip Morphology to Changes in Cartilage and Subchondral Bone
- ClinicalTrials.gov ID
- NCT01546493
- Acronym / sponsor ID
- 2009537
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 4 Aug 2010 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 7 Mar 2012 (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.
Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics and joint degradation to better identify 'at-risk' patients requiring corrective surgery will be scrutinized to gain a better understanding of the condition's natural history. The influence of certain morphologies (e.g. size and location of the deformity) will be analyzed to determine if this leads to aberrant loading of regions of the cartilage and subchondral bone, resulting in cartilage damage and joint degradation. Additionally, this research will determine if changes in the subchondral bone precede cartilage degeneration.
The methodology for establishing the morphology/cartilage degeneration relationship includes Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer simulation/finite element analysis.
The outcomes of this research may lead to a reduction in total hip replacement cases by as much as 70%, saving many Canadians from a painful and debilitating condition and reducing costs to the Canadian health care system by as much as $290 million annually.
Detailed description
The research objectives are:
- To determine the factors of cam deformities, including morphological, functional and bone quality, that are associated with cartilage degeneration through shape analysis, kinematic analysis, MRI imaging and bone densitometry.
- To determine whether subchondral bone changes occur before detectable cartilage degeneration by examining magnetic resonance images of asymptomatic subjects who have an identifiable deformity.
- To use 3D motion and finite element analysis to examine differences in mechanical stimuli in the subchondral bone and cartilage that are associated with FAI, thus expanding our understanding of the pathomechanisms of associated degeneration.
Three subject cohorts will be recruited: subjects with bilateral cam deformity and unilateral symptoms (Group I, 'active cartilage damage stage'), asymptomatic subjects with cam deformity (Group II, 'early stage') and asymptomatic control subjects with no deformity (Group III).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | Experimental | Radiation: MRI, Radiation: qCT, Other: Motion AnalysisAsymptomatic control subjects with no deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. |
| Symptomatics | Experimental | Radiation: MRI, Radiation: qCT, Other: Motion Analysis, Radiation: PET-MRISubjects with bilateral cam deformity and unilateral symptoms. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa. |
| Asymptomatic | Experimental | Radiation: MRI, Radiation: qCT, Other: Motion Analysis, Radiation: PET-MRIAsymptomatic subjects with cam deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Group I: Subjects with bilateral cam deformity and unilateral symptoms; Hip pain longer than 6 months referred to the groin/lateral aspect of hip; Positive impingement sign (determined by the surgeon); Plain radiographs: absence of arthritis (Tonnis Grade 0 or 1), absence of dysplasia (center edge >25 degrees) on AP radiograph, α-angle greater than 55 degrees on the Dunn view.
- Group II: Asymptomatic subjects with cam deformity; These patients will be recruited from our prevalence study (2006.813) with 200 asymptomatic individuals using MRI with radial sequences.
- Group III: Asymptomatic control subjects with no deformity; These patients will be recruited from our prevalence study (2006.813) which established their hip joint as having a normal femoral head neck contour. These subjects will be age-matched to Group I.
Key exclusion criteria (1 listed)
- Participants who do not meet the criteria above.
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 |
|---|---|---|
| MRIMRI scan. 3.0 Tesla MRI scans of both hips using Tip(T1-rho) and ultra-short echo time (UTE) sequences. | Radiation | Asymptomatic, Controls, Symptomatics |
| qCTQuantitative computed tomography(QCT) scans using a CT phantom | Radiation | Asymptomatic, Controls, Symptomatics |
| Motion Analysis3D motion analysis to assess hip function. | Other | Asymptomatic, Controls, Symptomatics |
| PET-MRIAlso: Positron emission tomography-magnetic resonance imagingPositron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will help us examine bone and cartilage at the molecular level. | Radiation | Asymptomatic, Symptomatics |
Primary outcome
Magnetic Resonance Imaging (MRI)
Time frame: 24 months
Patients will undergo MRI modalities which are sensitive to biochemical markers (T1-rho) and bone porosity (ultra-short echo time [UTE]) to evaluate joint cartilage. The T1-rho imaging is used to detect early molecular and biochemical alterations to cartilage while the UTE imaging is used to assess bone porosity. MRI scans will be completely pre-operatively and at a minimum of 24 months post-operatively.
3 secondary outcomes
Quantitative Computed Tomography (qCT)
Time frame: 24 months
Quantitative Motion Analysis to assess hip joint function
Time frame: 24 months
Positron emission tomography-magnetic resonance imaging (PET-MRI)
Time frame: 24 months or greater after original enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Related trials for Femoroacetabular Impingement
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
Active, not recruiting
Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
Not yet recruiting
Labral Repair vs Reconstruction
Femoral Acetabular Impingement
Not yet recruiting
3D MRI Assessment of Femoroacetabular Impingement in Patients With ACL Rupture - Exploratory Study
Femoroacetabular Impingement
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
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, qCT and Motion Analysis in people with Femoroacetabular Impingement, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Magnetic Resonance Imaging (MRI) (time frame: 24 months). 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 5 Jan 2024.