Plain English Summary
Background and study aims
Osteoarthritis (OA) is the most common form of arthritis and remains one of the few chronic diseases of ageing for which there is little, if any, effective treatment. Symptomatic knee osteoarthritis affects roughly 12% of people aged 60 and over and, despite medical advances, remains a major source of pain and functional limitation. While the main feature of OA is loss of cartilage (the protective surface that allows your joints to move smoothly), all parts of the joint are affected. Treatment development has focused on protecting the cartilage from damage. Another important potential source of OA pain is the lining of the joint (the synovium). Inflammation of the synovium is seen in about 50% of the knees of patients with painful OA. Since corticosteroid drugs reduce inflammation, injection of corticosteroids into the knee might be effective for the treatment of OA pain. The aim of this study is to determine whether patients with evidence of synovial inflammation in OA respond better to corticosteroids than those who do not, and whether treatment response is associated with change in synovial inflammation.
Who can participate?
Patients aged 40 - 79 years with symptomatic knee osteoarthritis (OA).
What does the study involve?
Participants have their knee aspirated (where a sterile needle and syringe are used to drain fluid) and injected with the corticosteroid drug methylprednisolone acetate (Depo-Medrone). We measure the changes in knee pain and inflammation of the synovium following the injection.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
May 2010 to May 2012
Who is funding the study?
Arthritis Research Campaign (ARC) (UK)
Who is the main contact?
Helen Williams
Helen.Williams@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Helen Elizabeth Williams
ORCID ID
Contact details
University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
-
Helen.Williams@manchester.ac.uk
Additional identifiers
EudraCT number
2009-015849-22
ClinicalTrials.gov number
Protocol/serial number
8358
Study information
Scientific title
An open-label study of intra-articular steroid injection in the management of symptomatic knee osteoarthritis
Acronym
TASK v1.2
Study hypothesis
Osteoarthritis (OA) of the knee is a common disorder and at present there are few effective therapies. Intra-articular (IA) steroids have been used in the management of knee OA, however, the results of these studies have been variable. The aim of this study is to determine factors which predict the improvement in pain in patients treated with IA steroids. In total 120 patients with knee OA will be studied in an open label study of IA steroids.
The primary outcome measure will be the change in knee pain following steroid injection. We plan to determine whether features of synovitis at baseline assessed both clinically and on magnetic resonance imaging (MRI) imaging predict response to steroids and whether change in features of synovitis, assessed using serial MRI scanning are associated with change in pain status. We will also determine the predictive ability of synovial fluid parameters and other factors including quality of life predict the response to steroids.
Ethics approval
Leicester 2 REC, 27/01/2010, ref: 09/H0402/107
Study design
Single-centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.inflammation-repair.manchester.ac.uk/roam
Condition
Topic: Musculoskeletal, Primary Care Research Network for England; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
Intervention
Participants will have their index knee aspirated and injected with 80 mg methylprednisolone acetate (Depo-Medrone). Subjects will have one injection only during the course of the study.
Follow up length: 6 months
Study entry: registration only
Intervention type
Drug
Phase
Phase IV
Drug names
Depomedrone
Primary outcome measures
Change in knee pain, analysis will focus on whether change in pain level from baseline to one week after the injection is given
Secondary outcome measures
1. Visual Analogue Scale (VAS) - global knee pain
2. VAS - pain on nominated activity
3. VAS - wellness
4. Knee injury and Osteoarthritis Outcome Score (KOOS) subscales
Data collected at each study visit, baseline, week 1 and 1 x follow-up.
Overall trial start date
04/05/2010
Overall trial end date
15/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 40 - 79 years
2. Male or female
3. Ambulatory (not wheelchair bound)
4. Able and willing to attend or comply with intervention and follow up
5. Within the last 24 months:
5.1. Radiological (X-ray) evidence of grade 2 or more OA
5.2. Evidence of significant OA on MRI scan
5.3. Documented evidence of at least grade 2 arthritis on arthroscopy
6. Moderate knee pain lasting 48 hours in the past 2 weeks
7. Presence of clinically apparent knee effusion
8. Written informed consent
9. Glomerular filtration rate (GFR) greater than 44 ml/min
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 120; UK sample size: 120
Participant exclusion criteria
1. Secondary OA - septic arthritis, gout
2. History of inflammatory arthritis
3. Previous intra-articular Ostenil or steroid injection within 6 months
4. Previous knee surgery (including cartilage surgery) or arthroscopy within 6 months
5. Inability to understand the procedures
6. Pregnancy
7. Chronic kidney disease with estimated glomerular filtration rate (eGFR) greater than or equal to 44 ml/min
8. Concurrent life threatening illness
9. Implants which prohibit safe use of MRI scan including cochlear implants/metal objects in the body including joint prosthesis, cardiac or neural pacemakers, hydrocephalus shunts, intrauterine device or coil
10. Known hypersensitivity to Depomedrone or any components of its excipients
11. Systemic infection (unless specific anti infective therapy is employed)
Recruitment start date
04/05/2010
Recruitment end date
10/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9PT
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Salford Royal NHS Foundation Trust (UK)
Sponsor details
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
-
lloyd.gregory@manchester.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
All publications will be open access and on PubMed when available
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26116548
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28482926