Condition category
Musculoskeletal Diseases
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
09/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.inflammation-repair.manchester.ac.uk/roam

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.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8358

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

http://www.srht.nhs.uk

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

Publication citations

Additional files

Editorial Notes

On 09/12/2015 the overall trial end date was changed from 04/05/2012 to 15/12/2014.