Femoroacetabular Hip Impingement SyndromeNCT00606047
Prevalence of Femoroacetabular Impingement in Asymptomatic Patients
An observational study of Femoroacetabular Hip Impingement Syndrome, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. In this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. Read more about this study
- Who is it for?
- Ages Up to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Hip Impingement Syndrome
- What is being tested?
- Magnetic resonance imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2007to 13 Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy volunteers
Who may be able to join
- No hip problems
- No containdications to MRI
Who cannot join
- Patient does not meet above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. In this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The purpose of this study is to investigate whether patients without hip pain have variations at the hip joint such as those seen in hip impingement syndrome.
Read the detailed description
Participants in this study will be asked to come to the hospital after regular work hours for an MRI of the hip joints. Prior to the MRI, a physician will perform a range of motion check of the participants hips. The MRI will take approximately 20 minutes during which the participant will have to lie still in a closed space. Participants will receive a letter which can be forwarded to their family doctor if the MRI has any abnormal findings including signs of hip impingement.
- Being tested
- Magnetic resonance imaging (MRI)
- Keywords
- femoroacetabular impingement
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Radiation
Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients | Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI). Receives: Radiation: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Femoroacetabular Impingement (FAI)
Prevalence of femoroacetabular impingement (FAI), a newly recognized cause of early arthritis of the hip, will be investigated by means of hip MRI to evaluate for abnormal morphology of the anterior head-neck junction of the femur. Participant MRIs were reviewed by two independent radiologists. The prevalence of FAI was calculated as determined by an abnormal alpha angle (greater than 50.5 degrees).
Measured: Pre-operative on Day of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study start1 Aug 2007
- Primary completionFeb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular Hip Impingement SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Beaulé, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606047
- Sponsor's protocol ID
- 2006-813
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2008
- Last updated
- 27 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khanna V, Caragianis A, Diprimio G, Rakhra K, Beaule PE. Incidence of hip pain in a prospective cohort of asymptomatic volunteers: is the cam deformity a risk factor for hip pain? Am J Sports Med. 2014 Apr;42(4):793-7. doi: 10.1177/0363546513518417. Epub 2014 Jan 30.
PubMed 24481825Hack K, Di Primio G, Rakhra K, Beaule PE. Prevalence of cam-type femoroacetabular impingement morphology in asymptomatic volunteers. J Bone Joint Surg Am. 2010 Oct 20;92(14):2436-44. doi: 10.2106/JBJS.J.01280.
PubMed 20962194
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Femoroacetabular Impingement in Asymptomatic Patients
- ClinicalTrials.gov ID
- NCT00606047
- Acronym / sponsor ID
- 2006-813
- Keywords
- femoroacetabular impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. In this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The purpose of this study is to investigate whether patients without hip pain have variations at the hip joint such as those seen in hip impingement syndrome.
Detailed description
Participants in this study will be asked to come to the hospital after regular work hours for an MRI of the hip joints. Prior to the MRI, a physician will perform a range of motion check of the participants hips. The MRI will take approximately 20 minutes during which the participant will have to lie still in a closed space. Participants will receive a letter which can be forwarded to their family doctor if the MRI has any abnormal findings including signs of hip impingement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic patients | – | Radiation: Magnetic resonance imaging (MRI)Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI). |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- No hip problems
- No containdications to MRI
Key exclusion criteria (1 listed)
- Patient does not meet above criteria
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 (MRI)Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints. | Radiation | Asymptomatic patients |
Primary outcome
Prevalence of Femoroacetabular Impingement (FAI)
Time frame: Pre-operative on Day of MRI
Prevalence of femoroacetabular impingement (FAI), a newly recognized cause of early arthritis of the hip, will be investigated by means of hip MRI to evaluate for abnormal morphology of the anterior head-neck junction of the femur. Participant MRIs were reviewed by two independent radiologists. The prevalence of FAI was calculated as determined by an abnormal alpha angle (greater than 50.5 degrees).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24481825Khanna V, Caragianis A, Diprimio G, Rakhra K, Beaule PE. Incidence of hip pain in a prospective cohort of asymptomatic volunteers: is the cam deformity a risk factor for hip pain? Am J Sports Med. 2014 Apr;42(4):793-7. doi: 10.1177/0363546513518417. Epub 2014 Jan 30.
- Results publication: PubMed 20962194Hack K, Di Primio G, Rakhra K, Beaule PE. Prevalence of cam-type femoroacetabular impingement morphology in asymptomatic volunteers. J Bone Joint Surg Am. 2010 Oct 20;92(14):2436-44. doi: 10.2106/JBJS.J.01280.
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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 Beaulé, 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?
An observational study of Femoroacetabular Hip Impingement Syndrome, 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 2 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: finished, as of the sponsor's last update on 27 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Femoroacetabular Impingement (FAI) (time frame: Pre-operative on Day of MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606047, which also lists 2 linked publications.
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 27 Mar 2020.