Condition category
Musculoskeletal Diseases
Date applied
08/11/2012
Date assigned
12/11/2012
Last edited
05/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Mark Blyth

ORCID ID

Contact details

Department of Trauma and Orthopaedics
Gatehouse Building
84 Castle St
Glasgow
G4 0SF
United Kingdom

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, Apley’s 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, Apley’s 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 measures

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

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

http://www.netscc.ac.uk

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

Federal/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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26243431

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.