Femoroacetabular, ImpingementNCT00605969
Dynamic Imaging of the Hip for Pre-operative Planning
A study testing Motion analysis and Computed Tomography in people with Femoroacetabular, Impingement, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
One of the leading causes of hip arthritis is femoro-acetabular impingement which means the hip joint is deformed such that the hip joint jams in the front when the hip is bent all the way forward. This can lead to significant damage to the hip joint and may result in the need for a total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular, Impingement
- What is being tested?
- Motion analysis and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Dec 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants (patients and controls) must be between the ages of 18 and 55, with a BMI less than 35.
- The patients must have a probable diagnosis of femoro-acetabular impingement (FAI). Their hip pain must have been ongoing for at least 3 months. The controls must have a normal hip as defined by AP pelvis radiographs.
Who cannot join
- Participants (patients and controls) will be excluded if they are pregnant, have a knee injury or replacement, or history of childhood hip disease. Patients will be excluded if have they have arthritis, previous fracture or trauma to the hip, previous hip surgery, dysplasia, or avascular necrosis. Controls will be excluded if they have hip pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hip Reconstruction and Modeling for Surgical Pre-Operative Planning
One of the leading causes of hip arthritis is femoro-acetabular impingement which means the hip joint is deformed such that the hip joint jams in the front when the hip is bent all the way forward. This can lead to significant damage to the hip joint and may result in the need for a total hip replacement. However, if detected early, this deformity can be treated surgically by reshaping the hip joint. If the hip joint could be better visualized before surgery, then surgeons would be able to develop less invasive surgical techniques to correct this deformity.
Read the detailed description
In this study, we are trying to develop a way to help surgeons visualize the hip joint before surgery in order to assist with pre-operative planning. This will be done by comparing the dynamic hip images in patients with femoroacetabular impingement to the hip images of healthy volunteers with no hip problems.
- Conditions
- Femoroacetabular, Impingement
- Being tested
- Motion analysis, Computed Tomography
- 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.
Motion analysisProcedure or surgery
Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.
Computed TomographyDiagnostic test
Participants will undergo computed tomography (CT) scan of their hip.
| Study group | Role | What they receive |
|---|---|---|
| FAI patients | Active comparator | This group consists of participants diagnosed with femoroacetabular impingement that are undergoing surgical correction. Receives: Procedure: Motion analysis; Diagnostic Test: Computed Tomography |
| Control | Placebo comparator | This group consists of healthy control participants with no hip problems. Receives: Procedure: Motion analysis; Diagnostic Test: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of kinematic model of hip joint
Development of a kinematical model of the hip joint to simulate virtual joint motion. This will be done by using automatic segmentation using the CT data to generate models.
Measured: Within 6 months of recruitment
Secondary outcomes (2)
Joint Kinetics
Retro-reflective markers will be placed on each participant in a laboratory setting. Joint kinematics will be reconstructed from marker trajectories recorded by a camera system. Together, with EMG data, the investigators will calculate joint kinetics
Measured: 24 months
Muscle Activity
Retro-reflective markers will be placed on each participant in a laboratory setting. Electromyography (EMG) electrodes will be placed on the skin above the tibialis anterior, medial and lateral gastrocnemius, vastus lateralis and medialis, biceps femoris, semitendinosis and gluteus maximums of both limbs. Muscle activity will be measured using EMG signal recorded during activity.
Measured: 24 months
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 startMay 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00605969
- Sponsor's protocol ID
- 2006-552
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2008
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng KC, Lamontagne M, Adamczyk AP, Rakhra KS, Beaule PE. Patient-specific anatomical and functional parameters provide new insights into the pathomechanism of cam FAI. Clin Orthop Relat Res. 2015 Apr;473(4):1289-96. doi: 10.1007/s11999-014-3797-1.
PubMed 25048279Kennedy MJ, Lamontagne M, Beaule PE. Femoroacetabular impingement alters hip and pelvic biomechanics during gait Walking biomechanics of FAI. Gait Posture. 2009 Jul;30(1):41-4. doi: 10.1016/j.gaitpost.2009.02.008.
PubMed 19307121Lamontagne M, Kennedy MJ, Beaule PE. The effect of cam FAI on hip and pelvic motion during maximum squat. Clin Orthop Relat Res. 2009 Mar;467(3):645-50. doi: 10.1007/s11999-008-0620-x. Epub 2008 Nov 26.
PubMed 19034598Lamontagne M, Brisson N, Kennedy MJ, Beaule PE. Preoperative and postoperative lower-extremity joint and pelvic kinematics during maximal squatting of patients with cam femoro-acetabular impingement. J Bone Joint Surg Am. 2011 May;93 Suppl 2:40-5. doi: 10.2106/JBJS.J.01809.
PubMed 21543687Brisson N, Lamontagne M, Kennedy MJ, Beaule PE. The effects of cam femoroacetabular impingement corrective surgery on lower-extremity gait biomechanics. Gait Posture. 2013 Feb;37(2):258-63. doi: 10.1016/j.gaitpost.2012.07.016. Epub 2012 Aug 28.
PubMed 22939410
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Reconstruction and Modeling for Surgical Pre-Operative Planning
- ClinicalTrials.gov ID
- NCT00605969
- Acronym / sponsor ID
- 2006-552
- Conditions
- Femoroacetabular, Impingement
- Keywords
- femoroacetabular, impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2007 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Feb 2008 (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.
One of the leading causes of hip arthritis is femoro-acetabular impingement which means the hip joint is deformed such that the hip joint jams in the front when the hip is bent all the way forward. This can lead to significant damage to the hip joint and may result in the need for a total hip replacement. However, if detected early, this deformity can be treated surgically by reshaping the hip joint. If the hip joint could be better visualized before surgery, then surgeons would be able to develop less invasive surgical techniques to correct this deformity.
Detailed description
In this study, we are trying to develop a way to help surgeons visualize the hip joint before surgery in order to assist with pre-operative planning. This will be done by comparing the dynamic hip images in patients with femoroacetabular impingement to the hip images of healthy volunteers with no hip problems.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAI patients | Active comparator | Procedure: Motion analysis, Diagnostic Test: Computed TomographyThis group consists of participants diagnosed with femoroacetabular impingement that are undergoing surgical correction. |
| Control | Placebo comparator | Procedure: Motion analysis, Diagnostic Test: Computed TomographyThis group consists of healthy control participants with no hip problems. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants (patients and controls) must be between the ages of 18 and 55, with a BMI less than 35.
- The patients must have a probable diagnosis of femoro-acetabular impingement (FAI). Their hip pain must have been ongoing for at least 3 months. The controls must have a normal hip as defined by AP pelvis radiographs.
Key exclusion criteria (1 listed)
- Participants (patients and controls) will be excluded if they are pregnant, have a knee injury or replacement, or history of childhood hip disease. Patients will be excluded if have they have arthritis, previous fracture or trauma to the hip, previous hip surgery, dysplasia, or avascular necrosis. Controls will be excluded if they have hip pain.
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 |
|---|---|---|
| Motion analysisParticipants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip. | Procedure or surgery | Control, FAI patients |
| Computed TomographyParticipants will undergo computed tomography (CT) scan of their hip. | Diagnostic test | Control, FAI patients |
Primary outcome
Validation of kinematic model of hip joint
Time frame: Within 6 months of recruitment
Development of a kinematical model of the hip joint to simulate virtual joint motion. This will be done by using automatic segmentation using the CT data to generate models.
2 secondary outcomes
Joint Kinetics
Time frame: 24 months
Muscle Activity
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Results publication: PubMed 25048279Ng KC, Lamontagne M, Adamczyk AP, Rakhra KS, Beaule PE. Patient-specific anatomical and functional parameters provide new insights into the pathomechanism of cam FAI. Clin Orthop Relat Res. 2015 Apr;473(4):1289-96. doi: 10.1007/s11999-014-3797-1.
- Results publication: PubMed 19307121Kennedy MJ, Lamontagne M, Beaule PE. Femoroacetabular impingement alters hip and pelvic biomechanics during gait Walking biomechanics of FAI. Gait Posture. 2009 Jul;30(1):41-4. doi: 10.1016/j.gaitpost.2009.02.008.
- Results publication: PubMed 19034598Lamontagne M, Kennedy MJ, Beaule PE. The effect of cam FAI on hip and pelvic motion during maximum squat. Clin Orthop Relat Res. 2009 Mar;467(3):645-50. doi: 10.1007/s11999-008-0620-x. Epub 2008 Nov 26.
- Results publication: PubMed 21543687Lamontagne M, Brisson N, Kennedy MJ, Beaule PE. Preoperative and postoperative lower-extremity joint and pelvic kinematics during maximal squatting of patients with cam femoro-acetabular impingement. J Bone Joint Surg Am. 2011 May;93 Suppl 2:40-5. doi: 10.2106/JBJS.J.01809.
- Results publication: PubMed 22939410Brisson N, Lamontagne M, Kennedy MJ, Beaule PE. The effects of cam femoroacetabular impingement corrective surgery on lower-extremity gait biomechanics. Gait Posture. 2013 Feb;37(2):258-63. doi: 10.1016/j.gaitpost.2012.07.016. Epub 2012 Aug 28.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion analysis and Computed Tomography 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 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 10 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validation of kinematic model of hip joint (time frame: Within 6 months of recruitment). 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 NCT00605969, which also lists 5 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 10 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.