Skip to main content
OpenTrials
Completed

NCT Number: NCT02883907

Advanced MR Imaging of Osteoarthritis

The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:

1. Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult. 2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.

Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies.

This study aims to help address these issues by:

1. Calculating effect sizes for MR measurements to inform sample size calculations for future studies. 2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.

The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 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 us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Group 1 Inclusion Criteria:

  • Meets American College of Rheumatology (ACR) criteria for OA
  • Kellgren-Lawrence grade 2-3 OA on knee radiograph
  • Medial compartment predominant disease
  • Neutral alignment
  • Aged 40-60
  • Body Mass Index (BMI) < 35 kg per square meter
  • Ambulatory and in good general health

Group 2 Inclusion Criteria:

  • No current symptoms of knee pain or stiffness or other clinical features of OA
  • Aged 40-60
  • BMI < 35 kg per square meter
  • Ambulatory and in good general health

Exclusion criteria

(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)
  • Contraindication to intravenous gadolinium based contrast medium administration (see 'Ethical Considerations' section)
  • Unable to consent

Treatment and study plan

Primary outcomes

  1. Mean cartilage T1rho relaxation time (milliseconds)

    Time frame: 1 year

  2. Mean cartilage T2 relaxation time (milliseconds)

    Time frame: 1 year

  3. Mean cartilage T1 relaxation time post gadolinium (milliseconds)

    Time frame: 1 year

    Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)

Secondary outcomes

  1. Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)

    Time frame: 1 year

    Semiquantitative scoring system

  2. Cartilage thickness values (millimeters)

    Time frame: 1 year

    Surface-based comparison using statistical parametric mapping

  3. Subchondral bone area (millimeters squared)

    Time frame: 1 year

  4. Dynamic contrast enhanced (DCE) quantitation of parameters

    Time frame: 1 year

    Multiple DCE parameters calculated allowing description of enhancement rate and pattern of synovium

  5. Subchondral bone texture index (arbitrary units)

    Time frame: 1 year

  6. Osteochondral junction integrity (semiquantitative grading, arbitrary units)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Acronym: AMROA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2016
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.