Cam Type FAI is a Cause of Hip Pain in the Young Adult and a Precursor to OA
NCT ID: NCT04080466
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
58 participants
INTERVENTIONAL
2021-02-20
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cam Group
This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Low-dose CT Scan
Low dose computed tomography, also known as qCT, 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. Participants will undergo a low dose CT scan of both hips.
Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.
Blood/Urine Collection
Collection of blood and urine allows the researchers to look for a biomarker in the blood and urine that might help to predict the evolution of disease/hip osteoarthritis. Identifying a marker in the blood and urine that could be used for early detection of individuals with cam deformity that are at-risk of hip degeneration could greatly improve patient care.
Participants in the Cam Group will undergo the blood and urine collection twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo a blood and urine collection once as part of the study.
Patient Reported Questionnaires
The purpose of the questionnaires is to assess how much trouble the participant is having with their hip and how it affects their quality of life.
Participants in the Cam Group will complete the questionnaires twice; once before surgery and once 2-years post-operative. Participants in the Control Group will complete the questionnaires once as part of the study.
EOS Scan
The EOS® uses a new imaging technique that allows precise measurement of the hip and pelvis geometry and structure. This innovative x-ray technique exposes participants to 2-10 times less radiation than a routine x-ray and can capture multiple images at once.
Participants in the Cam Group will undergo the EOS scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.
PET-MRI
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that allows physicians to examine bone and cartilage at the molecular level.
Participants in the Cam Group will undergo the scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.
Motion Analysis
Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising.
Participants in the Cam Group will undergo the Motion Analysis session twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the Motion Analysis session once as part of the study.
3T MRI
Participants will undergo a 3-Tesla (3T) Magnetic Resonance Imaging (MRI) of both hips.
Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.
Control Group
This group will consist of a matched cohort of control participants.
Low-dose CT Scan
Low dose computed tomography, also known as qCT, 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. Participants will undergo a low dose CT scan of both hips.
Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.
Blood/Urine Collection
Collection of blood and urine allows the researchers to look for a biomarker in the blood and urine that might help to predict the evolution of disease/hip osteoarthritis. Identifying a marker in the blood and urine that could be used for early detection of individuals with cam deformity that are at-risk of hip degeneration could greatly improve patient care.
Participants in the Cam Group will undergo the blood and urine collection twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo a blood and urine collection once as part of the study.
Patient Reported Questionnaires
The purpose of the questionnaires is to assess how much trouble the participant is having with their hip and how it affects their quality of life.
Participants in the Cam Group will complete the questionnaires twice; once before surgery and once 2-years post-operative. Participants in the Control Group will complete the questionnaires once as part of the study.
EOS Scan
The EOS® uses a new imaging technique that allows precise measurement of the hip and pelvis geometry and structure. This innovative x-ray technique exposes participants to 2-10 times less radiation than a routine x-ray and can capture multiple images at once.
Participants in the Cam Group will undergo the EOS scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.
PET-MRI
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that allows physicians to examine bone and cartilage at the molecular level.
Participants in the Cam Group will undergo the scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.
Motion Analysis
Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising.
Participants in the Cam Group will undergo the Motion Analysis session twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the Motion Analysis session once as part of the study.
3T MRI
Participants will undergo a 3-Tesla (3T) Magnetic Resonance Imaging (MRI) of both hips.
Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.
Interventions
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Low-dose CT Scan
Low dose computed tomography, also known as qCT, 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. Participants will undergo a low dose CT scan of both hips.
Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.
Blood/Urine Collection
Collection of blood and urine allows the researchers to look for a biomarker in the blood and urine that might help to predict the evolution of disease/hip osteoarthritis. Identifying a marker in the blood and urine that could be used for early detection of individuals with cam deformity that are at-risk of hip degeneration could greatly improve patient care.
Participants in the Cam Group will undergo the blood and urine collection twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo a blood and urine collection once as part of the study.
Patient Reported Questionnaires
The purpose of the questionnaires is to assess how much trouble the participant is having with their hip and how it affects their quality of life.
Participants in the Cam Group will complete the questionnaires twice; once before surgery and once 2-years post-operative. Participants in the Control Group will complete the questionnaires once as part of the study.
EOS Scan
The EOS® uses a new imaging technique that allows precise measurement of the hip and pelvis geometry and structure. This innovative x-ray technique exposes participants to 2-10 times less radiation than a routine x-ray and can capture multiple images at once.
Participants in the Cam Group will undergo the EOS scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.
PET-MRI
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that allows physicians to examine bone and cartilage at the molecular level.
Participants in the Cam Group will undergo the scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.
Motion Analysis
Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising.
Participants in the Cam Group will undergo the Motion Analysis session twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the Motion Analysis session once as part of the study.
3T MRI
Participants will undergo a 3-Tesla (3T) Magnetic Resonance Imaging (MRI) of both hips.
Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.
Eligibility Criteria
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Inclusion Criteria
* Absence of arthritis (Tonnis Grade 0 or 1)
* Absence of dysplasia (LCEA \> 25°) or overcoverage (LCEA \> 39°)
* Alpha angle greater than 55° on multiplanar imaging
* Subject is over the age of 18 years old at time of enrollment
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the approved Informed Consent Form
* Normal femoral head neck contour and no evidence of dysplasia
* Subject is over the age of 18 years old at time of enrollment
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the approved Informed Consent Form
Exclusion Criteria
* History of lower-limb joint or back injury in the last year that impairs mobility
* Metallic prosthesis
* Worked with metal, metal fragments in the eye
* Blood transmittable disease(s)
* In vivo devices (Aneurysm clip(s), Pacemaker, ICD, Implanted hearing device)
* Extreme claustrophobia
* Overweight or obese (BMI \> 30) and/or waist circumference \>102cm in men and \>88cm in women
* Diagnosis of Parkinson's or uncontrollable tremors
* Known history of early OA in the immediate family
* Pregnant, Breastfeeding, or planning to get pregnant
* Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires
* Patient unable/unwilling to complete all required follow-up visits
* Participants who have been exposed to other sources of radiation within the last year (Bringing radiation exposure above annual maximum)
18 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Paul Beaule, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital Research Institute
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20190456
Identifier Type: -
Identifier Source: org_study_id
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