- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04080466
Cam Type FAI is a Cause of Hip Pain in the Young Adult and a Precursor to OA
Cam Type Femoroacetabular Impingement (FAI) is a Cause of Hip Pain in the Young Adult and a Precursor to Osteoarthritis (OA)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Paul Beaule, MD, FRCSC
- Phone Number: 613-737-8920
- Email: pbeaule@toh.ca
Study Contact Backup
- Name: Cheryl Kreviazuk, BA
- Phone Number: 613-737-8920
- Email: ckreviazuk@ohri.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- The Ottawa Hospital
-
Contact:
- Cheryl Kreviazuk, BA
- Phone Number: 613-737-8920
- Email: ckreviazuk@ohri.ca
-
Principal Investigator:
- Paul E Beaule, MD, FRCSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Skeletally mature patient undergoing cam resection by hip arthroscopy with hip pain longer than 6 months
- 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
Group 2 Inclusion Criteria:
- 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:
- Prior joint replacement surgery in any lower-limb joint due to OA
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cam Group
This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
|
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. 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. 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. 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. 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 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. 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. |
Active Comparator: Control Group
This group will consist of a matched cohort of control participants.
|
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. 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. 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. 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. 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 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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of [18F]-NaF as a biomarker of hip degeneration
Time Frame: 24 months
|
This study will assess [18F]-NaF uptake in PET-MRI as a novel biomarker of hip degeneration.
This will be done by evaluating the presence of active bone turnover.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PET-MRI (SUV/T1Rho)
Time Frame: 24 months
|
Determine the change in PET-MRI (SUV/T1Rho) two years after surgical correction of a symptomatic cam deformity to discern disease state.
|
24 months
|
qCT (Low Dose Computed Tomography)
Time Frame: Within 2 months after recruitment
|
Used to measure bone mineral density (mass of mineral per volume of bone) in the subchondral bone.
Negative scores indicate lower bone density, and positive scores indicate higher.
|
Within 2 months after recruitment
|
Change in type II collagen telopeptide (CTX-II)
Time Frame: 24 months
|
Determine the change in urine biomarker levels (type II collagen telopeptide (CTX-II), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
|
24 months
|
Change in cartilage oligomeric matrix protein (COMP)
Time Frame: 24 months
|
Determine the change in serum biomarker levels (cartilage oligomeric matrix protein (COMP)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
|
24 months
|
Change in C-reactive protein (CRP)
Time Frame: 24 months
|
Determine the change in serum biomarker levels (C-reactive protein (CRP)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
|
24 months
|
Change in N-terminal cross-linking telopeptide of type I collagen (NTX-1)
Time Frame: 24 months
|
Determine the change in bone turnover plasma biomarker levels (N-terminal cross-linking telopeptide of type I collagen (NTX-1)) two years after surgical correction of a symptomatic cam deformity.
|
24 months
|
Change in carboxy-terminal collagen crosslinks (CTx)
Time Frame: 24 months
|
Determine the change in bone turnover plasma biomarker levels (carboxy-terminal collagen crosslinks (CTx)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
|
24 months
|
Change in N-terminal pro-peptide of type I procollagen (PINP)
Time Frame: 24 months
|
Determine the change in bone turnover serum biomarker levels (N-terminal pro-peptide of type I procollagen (PINP)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
|
24 months
|
Change in iHot-33 score
Time Frame: 24 months
|
The International Hip Outcome Tool (iHOT-33 is a questionnaire that evaluates young active patients with early hip disease.
The questionnaire is self-administered and assesses across 4 domains: symptoms and functional limitations; sport and recreational activities; job-related concerns; and social, emotional, and lifestyle concerns.
Questions are answered by marking a visual analog scale between 2 anchor statements (100-mm scale).
The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
|
24 months
|
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) score
Time Frame: 24 months
|
Hip-specific symptoms and functional impairment will be compared using the Hip Disability and Osteoarthritis Outcome Score (HOOS).
This 40-item patient reported outcome tool has 5 categories: pain, symptoms, daily living, quality of life, sports and recreational activities.
Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.
|
24 months
|
Change in EQ-5D-5L score
Time Frame: 24 months
|
This questionnaire assesses generic health status.
Each question is scored from 1-5, with 1 being no problems and 5 being severe problems.
These scores are not aggregated.
There are 5 domains: mobility, self-care, usual activities, pain and anxiety.
The final question is asking the participant to self score their health that day out of 100 (0 being the worst health and 100 being the best health).
|
24 months
|
Joint Kinematics to predict hip contact forces
Time Frame: 24 months
|
Retro-reflective markers will be placed on each participant in a laboratory setting.
Joint kinematics will be reconstructed from marker trajectories recorded by a 10- camera system (Vicon Vantage & Vicon Vero, Oxford, UK; frequency 200 Hz).
Together, with joint kinetics, the investigators will predict hip contact forces.
|
24 months
|
Joint kinetics to predict hip contact forces
Time Frame: 24 months
|
Retro-reflective markers will be placed on each participant in a laboratory setting.
Force platforms will record kinetic data.
Together, with joint kinetics, the investigators will predict hip contact forces.
|
24 months
|
Muscle Activity
Time Frame: 24 months
|
Retro-reflective markers will be placed on each participant in a laboratory setting.
Electromyography (EMG) electrodes will be placed over the following muscles: rectus femoris, vastus medialis, vastus lateralis, tensor fascia latea, biceps femoris, semitendinosus, gluteus medius and gluteus maximus.
Muscle activity will be measured using EMG signal recorded during maximum voluntary isometric contraction.
|
24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paul Beaule, MD, FRCSC, The Ottawa Hospital Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Hip Injuries
- Musculoskeletal Abnormalities
- Joint Dislocations
- Osteoarthritis
- Hip Dislocation
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
- Femoracetabular Impingement
Other Study ID Numbers
- 20190456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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