Diagnostic accuracy of the Thessaly test, the standardised clinical history, and other clinical examination tests for meniscal tears
| ISRCTN | ISRCTN43527822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43527822 |
| Secondary identifying numbers | HTA 09/163/02 |
- Submission date
- 08/11/2012
- Registration date
- 12/11/2012
- Last edited
- 05/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Department of Trauma and Orthopaedics
Gatehouse Building
84 Castle St
Glasgow
G4 0SF
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial Methodology: Case-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Diagnostic accuracy of the Thessaly test, the standardised clinical history, and other clinical examination tests for meniscal tears |
| 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(s) | West of Scotland Research Ethics Service, 16/10/2012, ref: 12/WS/0225 |
| 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 |
| 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 study start date | 28/11/2012 |
| Overall study end date | 05/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Knee patients = 300, control patients = 50 |
| Participant inclusion criteria | Knee patients referred to knee clinic at Glasgow Royal Infirmary Control patients - attending hand clinic at Glasgow Royal Infirmary |
| 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
- Scotland
- United Kingdom
Study participating centre
G4 0SF
United Kingdom
Sponsor information
Government
University of Southampton
Alpha House, Enterprise Road
Southampton
SO16 7NS
United Kingdom
| Website | http://www.netscc.ac.uk |
|---|---|
"ROR" |
https://ror.org/0187kwz08 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No |
Editorial Notes
05/05/2016: Publication reference added.
