Hip DysplasiaPhase 2NCT04080466
Cam Type FAI is a Cause of Hip Pain in the Young Adult and a Precursor to OA
A Phase 2 study testing Low-dose CT Scan, Blood/Urine Collection and Patient Reported Questionnaires in people with Hip Dysplasia and Femoroacetabular Impingement, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
An abnormally formed hip joint (cam deformity) is a major cause of osteoarthritis (OA). Individuals may not experience any symptoms until OA is severe due to extensive cartilage loss and changes in underlying bone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Dysplasia, Femoroacetabular Impingement, Osteoarthritis
- What is being tested?
- Low-dose CT Scan, Blood/Urine Collection and Patient Reported Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2021to Jan 2025
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Cheryl Kreviazuk, BA, 613-737-8920, ckreviazuk@ohri.ca
Paul E Beaule, MD, FRCSC
About this study
Official title: Cam Type Femoroacetabular Impingement (FAI) is a Cause of Hip Pain in the Young Adult and a Precursor to Osteoarthritis (OA)
An abnormally formed hip joint (cam deformity) is a major cause of osteoarthritis (OA). Individuals may not experience any symptoms until OA is severe due to extensive cartilage loss and changes in underlying bone. A series of studies showed that the cam deformity can lead to the development of OA if left untreated, thus strongly suggesting a causal relationship. Currently, the cam deformity that causes pain is surgically removed to relieve the pain and treat the associated cartilage damage. Recent studies have demonstrated that surgical treatment leads to bone and cartilage changes that were related to improved function and reduced pain.
Read the detailed description
This study will allow the investigators to gain a better understanding of the relationship between cartilage and bone changes. The investigators will examine adult participants in the disease state that require surgical correction and compare to age-matched controls. The investigators will look at the impact of surgical intervention through joint-specific biomarkers of OA, specifically the PET-MRI and blood/urine biomarkers, which will allow them to simultaneously query cartilage and bone activity. The investigators propose that the use of PET-MRI will give more sensitive and hip-specific information about the joint health compared to the blood/urine biomarkers in patients with symptomatic cam morphology. Participants will undergo motion analysis and 3D modeling to help the investigators better understand the disease process during the performance of specific activities and define joint contact mechanics as they relate to the PET-MRI imaging, validating a biomarker for early joint degeneration. This diagnostic tool will be extremely useful for younger individuals with a cam deformity who have not yet developed symptoms. In the future the investigators could use this to detect early degeneration in adolescents to prevent and mitigate development of OA later on. This will also help the investigators develop activity guidelines for people with smaller cam deformities in order to avoid surgery and prevent degeneration.
- Conditions
- Hip Dysplasia, Femoroacetabular Impingement, Osteoarthritis
- Being tested
- Low-dose CT Scan, Blood/Urine Collection, Patient Reported Questionnaires, EOS Scan, PET-MRI
- Keywords
- Hip, Cam deformity
- Medical subject headings
- Hip Dislocation, Femoracetabular Impingement, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CT ScanRadiation
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 CollectionOther
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 QuestionnairesOther
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 ScanRadiation
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-MRIRadiation
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 AnalysisOther
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 MRIRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Cam Group | Experimental | This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy. Receives: Radiation: Low-dose CT Scan; Other: Blood/Urine Collection; Other: Patient Reported Questionnaires; Radiation: EOS Scan; Radiation: PET-MRI; Other: Motion Analysis; Radiation: 3T MRI |
| Control Group | Active comparator | This group will consist of a matched cohort of control participants. Receives: Radiation: Low-dose CT Scan; Other: Blood/Urine Collection; Other: Patient Reported Questionnaires; Radiation: EOS Scan; Radiation: PET-MRI; Other: Motion Analysis; Radiation: 3T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of [18F]-NaF as a biomarker of hip degeneration
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.
Measured: 24 months
Secondary outcomes (14)
Change in PET-MRI (SUV/T1Rho)
Determine the change in PET-MRI (SUV/T1Rho) two years after surgical correction of a symptomatic cam deformity to discern disease state.
Measured: 24 months
qCT (Low Dose Computed Tomography)
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.
Measured: Within 2 months after recruitment
Change in type II collagen telopeptide (CTX-II)
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.
Measured: 24 months
Change in cartilage oligomeric matrix protein (COMP)
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.
Measured: 24 months
Change in C-reactive protein (CRP)
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.
Measured: 24 months
Change in N-terminal cross-linking telopeptide of type I collagen (NTX-1)
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.
Measured: 24 months
Change in carboxy-terminal collagen crosslinks (CTx)
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.
Measured: 24 months
Change in N-terminal pro-peptide of type I procollagen (PINP)
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.
Measured: 24 months
Change in iHot-33 score
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.
Measured: 24 months
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) score
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.
Measured: 24 months
Change in EQ-5D-5L score
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).
Measured: 24 months
Joint Kinematics to predict hip contact forces
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.
Measured: 24 months
Joint kinetics to predict hip contact forces
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.
Measured: 24 months
Muscle Activity
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.
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 posted6 Sep 2019
- Study start20 Feb 2021
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized, single centre trial with 2 parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
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 Beaule, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080466
- Sponsor's protocol ID
- 20190456
- Status last verified
- Jan 2024
- First submitted
- 22 Aug 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Cam Type Femoroacetabular Impingement (FAI) is a Cause of Hip Pain in the Young Adult and a Precursor to Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT04080466
- Acronym / sponsor ID
- 20190456
- Conditions
- Hip Dysplasia, Femoroacetabular Impingement, Osteoarthritis
- Keywords
- Hip, Cam deformity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Sep 2019 (actual)
- 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.
An abnormally formed hip joint (cam deformity) is a major cause of osteoarthritis (OA). Individuals may not experience any symptoms until OA is severe due to extensive cartilage loss and changes in underlying bone. A series of studies showed that the cam deformity can lead to the development of OA if left untreated, thus strongly suggesting a causal relationship. Currently, the cam deformity that causes pain is surgically removed to relieve the pain and treat the associated cartilage damage. Recent studies have demonstrated that surgical treatment leads to bone and cartilage changes that were related to improved function and reduced pain.
Detailed description
This study will allow the investigators to gain a better understanding of the relationship between cartilage and bone changes. The investigators will examine adult participants in the disease state that require surgical correction and compare to age-matched controls. The investigators will look at the impact of surgical intervention through joint-specific biomarkers of OA, specifically the PET-MRI and blood/urine biomarkers, which will allow them to simultaneously query cartilage and bone activity. The investigators propose that the use of PET-MRI will give more sensitive and hip-specific information about the joint health compared to the blood/urine biomarkers in patients with symptomatic cam morphology. Participants will undergo motion analysis and 3D modeling to help the investigators better understand the disease process during the performance of specific activities and define joint contact mechanics as they relate to the PET-MRI imaging, validating a biomarker for early joint degeneration. This diagnostic tool will be extremely useful for younger individuals with a cam deformity who have not yet developed symptoms. In the future the investigators could use this to detect early degeneration in adolescents to prevent and mitigate development of OA later on. This will also help the investigators develop activity guidelines for people with smaller cam deformities in order to avoid surgery and prevent degeneration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized, single centre trial with 2 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Cam Group | Experimental | Radiation: Low-dose CT Scan, Other: Blood/Urine Collection, Other: Patient Reported Questionnaires, Radiation: EOS Scan, Radiation: PET-MRI, Other: Motion Analysis, Radiation: 3T MRIThis group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy. |
| Control Group | Active comparator | Radiation: Low-dose CT Scan, Other: Blood/Urine Collection, Other: Patient Reported Questionnaires, Radiation: EOS Scan, Radiation: PET-MRI, Other: Motion Analysis, Radiation: 3T MRIThis group will consist of a matched cohort of control participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
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 |
|---|---|---|
| Low-dose CT ScanLow 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. | Radiation | Cam Group, Control Group |
| Blood/Urine CollectionCollection 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. | Other | Cam Group, Control Group |
| Patient Reported QuestionnairesThe 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. | Other | Cam Group, Control Group |
| EOS ScanThe 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. | Radiation | Cam Group, Control Group |
| PET-MRIPositron 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. | Radiation | Cam Group, Control Group |
| Motion AnalysisMotion 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. | Other | Cam Group, Control Group |
| 3T MRIParticipants 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. | Radiation | Cam Group, Control Group |
Primary outcome
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.
14 secondary outcomes
Change in PET-MRI (SUV/T1Rho)
Time frame: 24 months
qCT (Low Dose Computed Tomography)
Time frame: Within 2 months after recruitment
Change in type II collagen telopeptide (CTX-II)
Time frame: 24 months
Change in cartilage oligomeric matrix protein (COMP)
Time frame: 24 months
Change in C-reactive protein (CRP)
Time frame: 24 months
Change in N-terminal cross-linking telopeptide of type I collagen (NTX-1)
Time frame: 24 months
Change in carboxy-terminal collagen crosslinks (CTx)
Time frame: 24 months
Change in N-terminal pro-peptide of type I procollagen (PINP)
Time frame: 24 months
Change in iHot-33 score
Time frame: 24 months
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) score
Time frame: 24 months
Change in EQ-5D-5L score
Time frame: 24 months
Joint Kinematics to predict hip contact forces
Time frame: 24 months
Joint kinetics to predict hip contact forces
Time frame: 24 months
Muscle Activity
Time frame: 24 months
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.
- Individual participant dataSharing planned: No
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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 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 Phase 2 study testing Low-dose CT Scan, Blood/Urine Collection and Patient Reported Questionnaires in people with Hip Dysplasia and 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 12 inclusion and 14 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Paul Beaule, MD, FRCSC (613-737-8920, pbeaule@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of [18F]-NaF as a biomarker of hip degeneration (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.