OsteoarthritisFERARINCT03657303
Functional Exercise Response on osteoArthritis Relaxation Imaging
An observational study of Osteoarthritis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Osteoarthritis (OA) is the most prevalent cause of mobility impairment and disability in the elderly. Indications at early stages of OA include decreased organisation of the collagen matrix, loss of proteoglycans and increased hydration. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Magnetic resonance imaging (MRI)
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2019to Dec 2022
- Phase
- Observational
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group 1 will consist of 12 patients aged 40-60 who have presented to the Orthopaedic clinic with a painful knee, and have mild/moderate OA on plain radiographs (Kellgren- Lawrence grade 2-3). Group 2 will consist of 5 healthy volunteer controls, matched (1:2 ratio) to cases for age, sex and body mass index who do not have knee pain.
Who may be able to join
None listed.
Who cannot join
- History of ipsilateral lower limb fracture
- History of ipsilateral lower limb surgery (including arthroscopy)
- Metabolic bone disease
- Inflammatory arthritis
- Haematological malignancy
- Paget's disease
Show all 10Show fewer
- Bone metastases
- Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)
- No pregnant patients will be included
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Osteoarthritis (OA) is the most prevalent cause of mobility impairment and disability in the elderly. Indications at early stages of OA include decreased organisation of the collagen matrix, loss of proteoglycans and increased hydration. Late-stage joint disease can be diagnosed with X-ray, CT, and conventional MRI, but there are no validated methods to image early changes in cartilage microstructure, which are direly needed in early phase clinical development. Newly developed therapies and evaluation techniques are required at earlier stages of disease to offset the growing numbers and costs of end-stage disease.
MRI can probe soft-tissue with physical measurements that are not available through other methods. Quantitative MRI signal relaxation properties are particularly promising for assessing early changes in the cartilage composition. These relaxation properties are sensitive to water content and cartilage macromolecular structure.
Read more
Mechanical joint-loading and exercise affects quantitative MRI through cartilage compression and nonuniform deformation. A study measuring MRI relaxation times and using static joint-loading weights has shown differences between OA and healthy subjects. Cartilage volume, which is expected to be related to these relaxation times, recovers within an hour after exercise in healthy runners, with the menisci lagging in their volume recovery rate. Previous exercise studies have not measured post-exercise cartilage recovery using compositional techniques, such as physiologically-sensitive T1ρ and T2, nor probed compositional responses with OA subjects.
The investigators will examine a single knee of an initial 18 participants with MR. Participants will be drawn from two groups: (1) 12 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 6 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.
Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
This will allow the investigators to explore the possibility of mechanical joint-loading and exercise to differentiate early stage OA from healthy subjects and assess both the reliability of the MR measurements and the expected progression in the MR measurements in OA subjects in the absence of any disease-modifying intervention.
- Conditions
- Osteoarthritis
- Being tested
- Magnetic resonance imaging (MRI)
- Keywords
- Joint Diseases, Musculoskeletal Diseases, Arthritis
- Medical subject headings
- Osteoarthritis, Joint Diseases, Musculoskeletal Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Device
Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Device: Magnetic resonance imaging (MRI) | |
| Osteoarthritis patients | Not described Receives: Device: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish effect sizes for MR parameters in OA patients compared to healthy volunteers.
Measured: 1 year
Secondary outcomes (2)
Establish effect sizes for MR parameters in subjects with OA at 1 year compared to baseline.
Measured: 1 year
Establish reliability of the MR protocol and analysis techniques.
Test-Retest Reliability
Measured: 1 month - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start21 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Fiona J Gilbert, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657303
- Sponsor's protocol ID
- A094874
- Acronym
- FERARI
- Status last verified
- Jul 2022
- First submitted
- 31 Aug 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Exercise Response on osteoArthritis Relaxation Imaging
- ClinicalTrials.gov ID
- NCT03657303
- Acronym / sponsor ID
- FERARI / A094874
- Conditions
- Osteoarthritis
- Keywords
- Joint Diseases, Musculoskeletal Diseases, Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Sep 2018 (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.
Osteoarthritis (OA) is the most prevalent cause of mobility impairment and disability in the elderly. Indications at early stages of OA include decreased organisation of the collagen matrix, loss of proteoglycans and increased hydration. Late-stage joint disease can be diagnosed with X-ray, CT, and conventional MRI, but there are no validated methods to image early changes in cartilage microstructure, which are direly needed in early phase clinical development. Newly developed therapies and evaluation techniques are required at earlier stages of disease to offset the growing numbers and costs of end-stage disease.
MRI can probe soft-tissue with physical measurements that are not available through other methods. Quantitative MRI signal relaxation properties are particularly promising for assessing early changes in the cartilage composition. These relaxation properties are sensitive to water content and cartilage macromolecular structure.
Mechanical joint-loading and exercise affects quantitative MRI through cartilage compression and nonuniform deformation. A study measuring MRI relaxation times and using static joint-loading weights has shown differences between OA and healthy subjects. Cartilage volume, which is expected to be related to these relaxation times, recovers within an hour after exercise in healthy runners, with the menisci lagging in their volume recovery rate. Previous exercise studies have not measured post-exercise cartilage recovery using compositional techniques, such as physiologically-sensitive T1ρ and T2, nor probed compositional responses with OA subjects.
The investigators will examine a single knee of an initial 18 participants with MR. Participants will be drawn from two groups: (1) 12 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 6 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.
Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
This will allow the investigators to explore the possibility of mechanical joint-loading and exercise to differentiate early stage OA from healthy subjects and assess both the reliability of the MR measurements and the expected progression in the MR measurements in OA subjects in the absence of any disease-modifying intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Magnetic resonance imaging (MRI) |
| Osteoarthritis patients | – | Device: Magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1 will consist of 12 patients aged 40-60 who have presented to the Orthopaedic clinic with a painful knee, and have mild/moderate OA on plain radiographs (Kellgren- Lawrence grade 2-3). Group 2 will consist of 5 healthy volunteer controls, matched (1:2 ratio) to cases for age, sex and body mass index who do not have knee pain.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- History of ipsilateral lower limb fracture
- History of ipsilateral lower limb surgery (including arthroscopy)
- Metabolic bone disease
- Inflammatory arthritis
- Haematological malignancy
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)Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination. | Device | Healthy volunteers, Osteoarthritis patients |
Primary outcome
Establish effect sizes for MR parameters in OA patients compared to healthy volunteers.
Time frame: 1 year
2 secondary outcomes
Establish effect sizes for MR parameters in subjects with OA at 1 year compared to baseline.
Time frame: 1 year
Establish reliability of the MR protocol and analysis techniques.
Time frame: 1 month - 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 0 inclusion and 10 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 20 Jul 2022. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Establish effect sizes for MR parameters in OA patients compared to healthy volunteers. (time frame: 1 year). 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 20 Jul 2022.