Plain English Summary
Background and study aims
The menisci are two discs located in each knee. They play an important role in the function of the knee, providing load bearing, stress distribution and shock absorption across the knee. Tears in the menisci are a common knee injury that can cause pain in the joint. However, reliable non-invasive diagnosis of meniscal tears is difficult. There are a number of physical examination tests described that diagnose tears but all suffer from a lack of specificity and sensitivity, that is they sometimes diagnose tears where one does not exist or fail to diagnose tears when they do exist. The Thessaly test is a new clinical examination used to detect meniscal tears in the knee and is claimed to have high sensitivity and specificity. It may be suitable as an inexpensive diagnostic tool to differenciate patients who do and do not require to be referred on to hospital for expensive MRI scans and arthroscopy (is keyhole surgery that is used to diagnose joint problems and repair joint damage) which will save large sums of money for the NHS as well as preventing unnecessary additional procedures for patients.
Who can participate?
The study will recruit two groups of patients, one group with knee pain and on group without knee pain.
What does the study involve?
Patients recruited to the study who have existing knee pain will follow standard assessment pathways. This will involve assessment by an experienced musculoskeletal clinician followed by an X-Ray and MRI scan of the knee. The only additional procedure for this group of knee patients will be a subsequent knee examination by a primary healthcare professional (GP or physiotherapist). The second group of patients with no knee pain (control patients) will also be asked to undergo physical knee examination by an experienced musculoskeletal clinician and a a primary healthcare professional (GP or physiotherapist) followed by an MRI scan of the knee.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part in this study. However, by participating the diagnostic accuracy of the Thessaly tests can be determined and whether it is a good alternative to MRI scans and arthroscopy to determine meniscal tears. If the Thessaly test, or any combination of tests used during this study, are good at diagnosing meniscal tears they could be used by primary healthcare professionals (GP and physiotherapist) and prevent people without meniscal tears going to hospital for MRI scans and knee arthroscopy. This could also free up additonal NHS resources. There are no risks in taking part in this study. The only disadvantage is that the clinic appiointments will take slightly longer as additional physical examinations of the knee will be carried out. For those patients recruited to the control group there will also be an additional hospital visit for an MRI scan of the knee.
Where is the study run from?
The study is being run at Glasgow Royal Infirmary Orthopaedic department.
When is the study starting and how long is it expected to run for?
The study will commence in December 2012 and will recruit patients for approximately 9 months.
Who is funding the study?
The study is funded by the National Institute for Health Research - Health Technology Assessment Programme.
Who is the main contact?
Dr Katriona Brooksbank, Research Manager
katriona.brooksbank@ggc.scot.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 09/163/02
Study information
Scientific title
Diagnostic accuracy of the Thessaly test, the standardised clinical history, and other clinical examination tests for meniscal tears
Acronym
Study hypothesis
1. To determine the diagnostic accuracy of the Thessaly test by GPs for meniscal tear in the knee and whether this test can obviate the need for further investigation by arthroscopy or magnetic resonance imaging (MRI).
2. To determine how the Thessaly test compares to clinical history and other commonly used physical examinations (McMurray test, Apleys test, joint line tenderness test) in diagnosing meniscal tears by GPs.
3. To determine if the presence of arthritis or other knee pathologies influences the accuracy of the Thessaly.
4. To determine if the use of combinations of physical tests (such as the Thessaly test, McMurray test, Apleys test and or joint line tenderness test) by GPs provides better specificity and sensitivity than a single test alone in the diagnosis of meniscal tear.
5. To determine the ability of non-specialist General Practitioners to use the Thessaly test in comparison to specialist knee clinicians.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0916302
Ethics approval
West of Scotland Research Ethics Service, 16/10/2012, ref: 12/WS/0225
Study design
Single-centre randomised controlled trial
Methodology: Case-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Meniscal tear in knees
Intervention
We do not plan to make any direct interventions in either of our patient groups. We will merely make assessments of patients knees (both healthy and knee patients) using physical examinations, X-ray and MRI scans (however X-rays will only be on the knee patients).
The randomisation in the study is with regard to the order of physical examination tests. The methodology for this study is case control.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Sensitivity and specificity of the Thessaly test, in determining the presence of meniscal tears, when employed by General Practitioners.
Secondary outcome measures
1. Sensitivity and specificity of the Thessaly test, in determining the presence of meniscal tears, when employed by specialist knee clinicians.
2. Sensitivity and specificity of the McMurray test, Apley test, joint line tenderness test and clinical history in determining the presence of meniscal tears.
3. Determination of the influence of osteoarthritis on the sensitivity and specificity of the Thessaly test, McMurray test, Apley test and joint line tenderness test.
4. Determine of the influence of other knee pathology such as ACL (anterior cruciate ligament) damage on the sensitivity and specificity of the Thessaly test, McMurray test, Apley test and joint line tenderness test.
5. Determination of the optimal combination of physical tests for most accurate diagnosis of meniscal tear in a primary care setting.
Overall trial start date
28/11/2012
Overall trial end date
05/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Knee patients referred to knee clinic at Glasgow Royal Infirmary
Control patients - attending hand clinic at Glasgow Royal Infirmary
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Knee patients = 300, control patients = 50
Participant exclusion criteria
Knee patients
1. Age under 18 years
2. Unable to give informed consent
3. Previous knee replacement on referred knee
Control patients
1. Age under 18 years
2. Unable to give informed consent
3. Previous knee replacement on referred knee
4. History of knee pain (last 6 months)
5. Osteoarthritis
6. Rheumatoid arthritis
Recruitment start date
28/11/2012
Recruitment end date
05/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
Sponsor information
Organisation
National Institute for Health Research (UK)
Sponsor details
University of Southampton
Alpha House
Enterprise Road
Southampton
SO16 7NS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26243431