Understanding the disease process of young patients with a meniscal tear of the knee and response to treatment
| ISRCTN | ISRCTN11534691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11534691 |
| IRAS number | 259098 |
| Secondary identifying numbers | CPMS 41432, IRAS 259098 |
- Submission date
- 22/02/2021
- Registration date
- 08/04/2021
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The meniscus is a cartilage based structure within the knee which is susceptible to damage or tears following high energy injury or low energy injury in a knee with signs of arthritis. Treatment for meniscal tears can include either physiotherapy or surgery where the damaged meniscus is removed. Recent high quality studies have shown physiotherapy is as effective as surgery in patients over 55. A potential reason for this is in patients over 55 there may be coexisting arthritis within the knee which is the source of symptoms rather than the meniscal tear. There is a clear need for high quality trial in younger patients aged under 55. Before a trial is commenced it is imperative to understand the trial population better.
The purpose of this study is to identify the symptoms patient present with, the presence of signs of arthritis on imaging and whether these features influence treatment outcome. We also aim to explore patient experiences of living with a meniscal tear.
Who can participate?
Patients under 55 years old, with an isolated meniscal tear.
What does the study involve?
We will follow up patients to identify the symptoms and imaging findings patients present with. We will then follow up these patients over one year to identify if these symptoms or imaging signs affect treatment success. In addition we will identify the current treatment pathways for patients with a meniscal tear.
20 participants from the main study will be invited to take part in interviews where we aim to identify patient experiences on living with a meniscal tear and views on a future large scale trial.
What are the possible benefits and risks of participating?
No direct risks or benefits.
This study will provide clinicians with a greater understanding of meniscal tears in young patients and help aid treatment decisions.
Where is the study run from?
University Hospital Coventry and Warwickshire (UK)
When is the study starting and how long is it expected to run for?
December 2018 to May 2022.
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Imran Ahmed, Imran.ahmed4@nhs.net
Contact information
Scientific
Warwick Clinical Trials Unit and University hospital Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| Imran.ahmed4@nhs.net |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN11534691_PIS_v3.docx |
| Scientific title | The MEniscal TeaR Outcome (METRO) study |
| Study acronym | METRO |
| Study objectives | The aim is to investigate factors that explain the variability in patient reported outcome measures following treatment for meniscal tears. |
| Ethics approval(s) | Approved 12/04/2019, Black Country REC board (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8284; blackcountry.rec@hra.nhs.uk), ref: 19/WM/0079 |
| Health condition(s) or problem(s) studied | Presentation, treatment, and recovery for a meniscal tear of the knee |
| Intervention | Potential participants will be identified by attending clinical teams or clinical research teams by screening orthopaedic clinic lists e.g. fracture clinic, acute knee clinic or an elective knee clinic. Potential participants will be approached for the study once they have had their clinical consultation. There will be no change to their standard clinical care determined by the health care professional who reviews the patient in the clinic. If they meet the study criteria they will be provided with a patient information sheet and consent form. The potential participant will then have time to review the study information and can either provide written confirmation of consent during that clinic visit or at a later date. If the participant would like more time to review the information, a member of the study team will take contact details of the participant (with documented verbal consent) and will contact the participant at a later date to address any queries. The participant can then provide written confirmation of consent via post. Once confirmation of consent has been received, participants will complete a baseline questionnaire. This will collect baseline demographics including age, gender and body mass index. The questionnaire will also collect information regarding the knee injury including the possible date and mechanism of injury as well as key symptoms. Three baseline patient-reported outcome tools will be collected at this point: Western Ontario Meniscal Tear Evaluation Tool (WOMET), Knee Injury and Osteoarthritis Outcome Score (KOOS4) and EuroQol (EQ-5D-5L). The study team will also review the Magnetic Resonance Imaging (MRI) scan used to confirm the diagnosis of a meniscal tear as part of standard clinical practice. This scan will be reviewed for type/pattern and location of the tear, assessment of arthritis using Whole Organ Magnetic resonance Score (WORMS), anonymised scans will also be reviewed by IMorphics ltd to assess bone volume (a novel measure of arthritis). Participants will receive a 3-month questionnaire where they will complete the WOMET, Eq-5D-5l and Patient Global Impression of change score (PGIC). In addition, the 3-month questionnaire will also collect adverse events. This questionnaire can either be completed face to face, via post or email depending on participant preference. Participants will then receive a 6-month questionnaire including WOMET, EQ-5D-5L, PGIC and adverse events. This can again be completed as above. Final data collection will occur 12 months following recruitment to the study where we will collect WOMET, EQ-5D-5L, PGIC, KOOS4 and adverse events. If a participant expresses interest on the initial consent form a small number of participants (20) will be invited to take part in semi structured interviews (METRO Interview study). This can either be done over the phone or face to face depending on participant preference. Interviews will last 45-60 minutes and will explore participant experience of living with a meniscal tear and their views on a future trial. All interviews will be audio recorded in order to be transcribed at a later date. Quotations may be used from the interviews in future medical publications but all patient identifiable information will be removed. Interviews will take place 3-9 months following recruitment. The study will end after the 12-month follow-up questionnaire has been received. |
| Intervention type | Other |
| Primary outcome measure | Meniscal tear disease-specific quality of life measured using the Western Ontario Meniscal Evaluation Tool (WOMET) at baseline, 3, 6 and 12 months |
| Secondary outcome measures | 1. Knee injury impact on person measured using the Knee injury and Osteoarthritis outcome score 4 (KOOS) at baseline and 12 months 2. Quality of life measured using the EQ-5D-5L at baseline, 3, 6 and 12 months 3. Participant perception of improvement measured using the Patient global assessment of change (PGIC) at 3, 6 and 12 months 4. Surgery for the meniscal tear (yes/no) measured by self-report at 3, 6 and 12 months |
| Overall study start date | 01/12/2018 |
| Completion date | 30/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Key inclusion criteria | 1. Provision of written informed consent 2. Age 18 – 55 years 3. Presence of a MRI confirmed meniscal tear |
| Key exclusion criteria | 1. Anterior cruciate ligament or other major knee ligament injury. This does not include a previous unrelated healed medial collateral ligament tear or a meniscal root tear (which is considered a type of meniscal tear in this study) 2. Associated intra-articular fracture of the tibial plateau or femur. Previous fractures not thought to be related to the tear are not an exclusion criteria for the study 3. Previous knee surgery 4. Previous entry into the present study (i.e other knee) 5. Unable to provide informed consent or undertake study procedures |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 30/07/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Coventry
CV2 2DX
United Kingdom
Bristol Rd South
Northfield
Birmingham
B31 2AP
United Kingdom
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Nuneaton
CV10 7DJ
United Kingdom
King's Norton
Birmingham
B30 3QY
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
Sponsor information
University/education
Gibbet Hill Road
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 (0)24 765 75386 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 12/07/2020 | 05/03/2021 | Yes | No | |
| Participant information sheet | version v3 | 09/04/2021 | No | Yes | |
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | Qualitative thematic analysis of semistructured interviews to identify key patient experiences | 14/01/2025 | 21/01/2025 | Yes | No |
Additional files
- ISRCTN11534691_PIS_v3.docx
- uploaded 09/04/2021
Editorial Notes
21/01/2025: Publication reference added.
09/04/2021: The participant information sheet was uploaded as an additional file.
22/02/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)
