Advanced MR Imaging of Osteoarthritis

NCT ID: NCT02883907

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2018-11-01

Brief Summary

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.

Conditions

Osteoarthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

No interventions assigned to this group

Osteoarthritis patients

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Jamie MacKay

Clinical Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Other Identifiers

609/M/C/1670

Identifier Type: -

Identifier Source: org_study_id