Targeting synovitis in knee osteoarthritis
| ISRCTN | ISRCTN07329370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07329370 |
| EudraCT/CTIS number | 2009-015849-22 |
| Secondary identifying numbers | 8358 |
- Submission date
- 21/05/2010
- Registration date
- 21/05/2010
- Last edited
- 10/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom
| Helen.Williams@manchester.ac.uk |
Study information
| Study design | Single-centre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.inflammation-repair.manchester.ac.uk/roam |
| Scientific title | An open-label study of intra-articular steroid injection in the management of symptomatic knee osteoarthritis |
| Study acronym | TASK v1.2 |
| Study objectives | 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(s) | Leicester 2 REC, 27/01/2010, ref: 09/H0402/107 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Depomedrone |
| Primary outcome measure | 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 study start date | 04/05/2010 |
| Completion date | 15/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 120; UK sample size: 120 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 04/05/2010 |
| Date of final enrolment | 10/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
M13 9PT
United Kingdom
Salford
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
Hope Hospital
Stott Lane
Salford
M6 8HD
England
United Kingdom
| lloyd.gregory@manchester.ac.uk | |
| Website | http://www.srht.nhs.uk |
"ROR" |
https://ror.org/019j78370 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | All publications will be open access and on PubMed when available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No | |
| Results article | results | 08/05/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/05/2017: Publication reference added.
09/12/2015: The overall trial end date was changed from 04/05/2012 to 15/12/2014.
