Welcome
Support Centre
18 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
TArgeting Synovitis in Knee osteoarthritis (OA)
ISRCTN ISRCTN07329370
DOI 10.1186/ISRCTN07329370
ClinicalTrials.gov identifier
EudraCT number 2009-015849-22
Public title TArgeting Synovitis in Knee osteoarthritis (OA)
Scientific title An open label study of intra-articular steroid injection in the management of symptomatic knee osteoarthritis (OA)
Acronym TASK v1.2
Serial number at source 8358
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.
Lay summary
Ethics approval Leicester 2 REC approved on the 27th January 2010 (ref: 09/H0402/107)
Study design Single centre non-randomised interventional treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Musculoskeletal, Primary Care Research Network for England; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
Participants - 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
Participants - 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)
Anticipated start date 04/05/2010
Anticipated end date 04/05/2012
Status of trial Completed
Patient information material Can be found at http://www.medicine.manchester.ac.uk/epidemiology/research/arc/clinicalepidemiology/roam
Target number of participants Planned sample size: 120; UK sample size: 120
Interventions 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
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding Arthritis Research Campaign (ARC) (UK)
Trial website http://www.medicine.manchester.ac.uk/epidemiology/research/arc/clinicalepidemiology/roam
Publications
Contact name Mrs  Helen Elizabeth  Williams
  Address University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PT
  Country United Kingdom
  Email Helen.Williams@manchester.ac.uk
Sponsor Salford Royal NHS Foundation Trust (UK)
  Address Hope Hospital
Stott Lane
  City/town Salford
  Zip/Postcode M6 8HD
  Country United Kingdom
  Email lloyd.gregory@manchester.ac.uk
  Sponsor website: http://www.srht.nhs.uk
Date applied 21/05/2010
Last edited 25/05/2010
Date ISRCTN assigned 21/05/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.