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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Mrs Helen Elizabeth Williams
Scientific

University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom

Email Helen.Williams@manchester.ac.uk

Study information

Study designSingle-centre non-randomised interventional treatment trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Can be found at http://www.inflammation-repair.manchester.ac.uk/roam
Scientific titleAn open-label study of intra-articular steroid injection in the management of symptomatic knee osteoarthritis
Study acronymTASK v1.2
Study objectivesOsteoarthritis (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) studiedTopic: Musculoskeletal, Primary Care Research Network for England; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Depomedrone
Primary outcome measureChange in knee pain, analysis will focus on whether change in pain level from baseline to one week after the injection is given
Secondary outcome measures1. 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 date04/05/2010
Completion date15/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 120; UK sample size: 120
Key inclusion criteria1. 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 criteria1. 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 enrolment04/05/2010
Date of final enrolment10/06/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University of Manchester
Manchester
M13 9PT
United Kingdom
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor information

Salford Royal NHS Foundation Trust (UK)
Hospital/treatment centre

Hope Hospital
Stott Lane
Salford
M6 8HD
England
United Kingdom

Email lloyd.gregory@manchester.ac.uk
Website http://www.srht.nhs.uk
ROR logo "ROR" https://ror.org/019j78370

Funders

Funder type

Charity

Arthritis Research Campaign (ARC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planAll 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.