Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Exercise Response on osteoArthritis Relaxation Imaging (FERARI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657303
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Fiona J Gilbert, Cambridge University Hospitals NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment
Osteoarthritis Device: Magnetic resonance imaging (MRI)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Exercise Response on osteoArthritis Relaxation Imaging
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy volunteers Device: 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.

Osteoarthritis patients Device: 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.




Primary Outcome Measures :
  1. Establish effect sizes for MR parameters in OA patients compared to healthy volunteers. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Establish effect sizes for MR parameters in subjects with OA at 1 year compared to baseline. [ Time Frame: 1 year ]
  2. Establish reliability of the MR protocol and analysis techniques. [ Time Frame: 1 month - 1 year ]
    Test-Retest Reliability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Group 1 Inclusion Criteria:

  • Meets ACR criteria for OA Kellgren-Lawrence grade 2-3 on knee radiograph
  • Neutral alignment
  • Single symptomatic joint
  • Aged 40-60 years old
  • Ambulatory and in good general health
  • Knee able to fit inside in-vivo knee coil (approx. 18 cm diameter)

Group 2 Inclusion Criteria:

  • No current symptoms of knee pain or stiffness or other clinical features of OA
  • Aged 40-60 years old
  • Written consent to participate in the study
  • Ambulatory and in good general health
  • Knee able to fit inside in-vivo knee coil (approx. 18 cm diameter)

Exclusion Criteria for both groups:

  • History of ipsilateral lower limb fracture
  • History of ipsilateral lower limb surgery (including arthroscopy)
  • Metabolic bone disease
  • Inflammatory arthritis
  • Haematological malignancy
  • Paget's disease
  • Bone metastases
  • Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)
  • No pregnant patients will be included
  • Unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657303


Contacts
Layout table for location contacts
Contact: Dimitri A Kessler +447711266011 dak50@cam.ac.uk

Locations
Layout table for location information
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust

Layout table for additonal information
Responsible Party: Professor Fiona J Gilbert, Head of Department - Radiology, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03657303    
Other Study ID Numbers: A094874
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Fiona J Gilbert, Cambridge University Hospitals NHS Foundation Trust:
Joint Diseases
Musculoskeletal Diseases
Arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases