For people with pain after a meniscectomy, but without established OA, does a treatment strategy of undertaking MAT surgery or personalised knee therapy result in better clinical and/or cost effectiveness outcomes?
| ISRCTN | ISRCTN87336549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87336549 |
| IRAS number | 307686 |
| Secondary identifying numbers | IRAS 307686, NIHR131629, CPMS 54157 |
- Submission date
- 01/09/2022
- Registration date
- 02/09/2022
- Last edited
- 02/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
The meniscus is an important structure within the knee. One of its key roles is to cushion impact and protect the gliding surface of the joint from wear. Patients that have damaged their meniscus, and had a removal of the meniscus (a total meniscectomy), are more likely to develop persistent pain after this resulting in years of disability.
At present, there are several treatment options ranging from knee therapy (physiotherapy) to a replacement meniscus also known as a ‘meniscal transplant’. Meniscal transplant is thought to provide cushioning to the joint surfaces and improve symptoms but it has a long recovery period and the operation carries risk of surgery as well as not helping with symptoms. At present, there is no direct evidence that meniscal transplant is better or worse than a specific targeted rehabilitation and therapy program.
In this study, we will compare two treatments for patients with a total meniscectomy.
Who can participate?
Adults with knee pain and/or functional limitation following meniscectomy but without large areas of articular cartilage loss or established OA.
What does the study involve?
One group of patients will have a course of personalised knee therapy and the other group will have a meniscal transplant. In total 144 participants will be recruited from 12 NHS Trust and 3 International sites and followed-up for 24 months post randomisation.
What are the possible benefits and risks of participating?
There are no specific benefits to taking part. Both treatments are designed to help reduce the symptoms you currently feel in your knee. By taking part in the trial, you are helping to decide about the best treatment for people in the future.
There are no special risks over and above what your doctor would normally inform you about. There are risks with meniscal transplant surgery, including surgical risks of tearing the new meniscus, persistent knee pain, infection, and blood clots, but these are the same risks for patients that do not take part in the study. The risks of the operation will be discussed in more detail with you by the clinical team who are looking after you in hospital, as part of your consent to treatment.
The risks associated with personalised knee therapy are also the same for patient that do not take part in the study. These may include temporary muscle soreness from exercise. A knee brace may be offered as part of both personalised therapy, and they are routinely used in recovery from surgery. They may provide good pain relief and are important after surgery to protect the recovering tissues. They may be uncomfortable or inconvenient. The personalised knee therapy programme is likely to be a shorter wait compared with surgery. We do not know which treatment would give a better improvement in the long-term that is what this study is trying to find out.
Where is the study run from?
University of Warwick (UK)
When is the study starting and how long is it expected to run for?
June 2022 to November 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Miss Natalie Hammonds, meteor2@warwick.ac.uk
Contact information
Scientific
University of Warwick
Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom
| Phone | +44 2476575194 |
|---|---|
| meteor2@warwick.ac.uk |
Study information
| Study design | Two-arm multi-centred pragmatic randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42316 PIS_V1_3Aug2022.pdf |
| Scientific title | The Meniscal Transplant Surgery or Optimised Rehabilitation - Full Randomised Controlled Trial |
| Study acronym | METEOR2 |
| Study hypothesis | For people with pain after a meniscectomy, but without established OA, does a treatment strategy of undertaking MAT surgery or personalised knee therapy result in better clinical and/or cost effectiveness outcomes? |
| Ethics approval(s) | Approved 19/08/2022, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048272; bloomsbury.rec@hra.nhs.uk), ref: 22/LO/0327 |
| Condition | Adults with knee pain and/or functional limitation following meniscectomy but without large areas of articular cartilage loss or established OA. |
| Intervention | Participants are randomised to personalised knee therapy or meniscal transplant surgery. Participants will be randomly allocated (1:1) to the two treatment groups via a central computer-based randomised system provided by the Warwick Clinical Trials Unit’s programming team. Randomisation will be 1:1 allocation by minimisation with a random factor with a 70% weighting towards balance across the whole study, stratified by age (greater or equal to 30, or less than 30), centre and knee compartment (lateral or medial). Personalised Knee Therapy: The PKT programme is an optimised non-surgical intervention (i.e. optimised rehabilitation) to improve the outcomes of people with knee pain and/or functional limitation following meniscectomy. The programme is outlined below: PKT Aim: To reduce pain, restore full knee range of motion, improve function, and optimise overall social participation through a goal-setting approach personalised to the participant. Delivered by: A senior physiotherapist trained in the principles of PKT Mode of delivery: The intervention will be personalised to the participant. Through this there is flexibility, as determined by clinical judgement and service provision at the time, for PKT to be delivered face-to-face, through virtual consultation or a hybrid of the two. Duration: Minimum of 3 months from first assessment and a minimum of four sessions in total, but would be as many as clinically required, reflecting normal clinical practice. Treatment starting point from randomisation: When an appointment with a physiotherapy appointment is available according to normal clinical waiting times. Typical waiting times for physiotherapy appointments at the lead site are approximately 2-3 months, but this may vary depending on individuals’ sites’ usual processes. Time of consultations: The interval between consultants will be personalised to the needs of the participant based on the progress, presentation, and treatment goals. This will be a shared decision between physiotherapist and participant. Content of consultants: Assessment: All participant will be reviewed in an initial assessment by a physiotherapist. In this, the participant’s history (subjective assessment) and physical examination (objective assessment) will be taken. This will follow a routine musculoskeletal physiotherapy assessment made to the participant's rehabilitation, optimising their outcome. Through this, the physiotherapist and participant, through discussion and clinical reasoning, select intervention in a menu-approach, to personalise the rehabilitation to the participant. The specific exercises, interventions, dosage, intensity, and frequency of exercise will be determined by the presenting participant and prescribed accordingly by their physiotherapist. This ensures a personalised programme is offered as part of PKT (and is consistent with good quality physiotherapy care in routine practice). MAT Surgery: MAT surgery will be done will done once an allograft becomes available and will follow a trial-specific surgical manual. All care including the choice of anaesthetic, the surgical procedure and post-operative analgesia, will be in accordance with usual procedures and care at participating sites. Fidelity and process measures will be assessed using a surgical care report form which will include details of surgery (surgical findings, theatre time, tourniquet time, graft size, fixation of graft, an other procedures) and the anaesthetic on a case report form (CRF). Rehabilitation for the surgery group will be according to a standardised programme specific to MAT. We will use the lead centre’s established programme for this and, in discussion with participating centres, adapt it to ensure it is delivered across multiple NHS and international sites in a multi-centre trial. This will be led by the physiotherapy co-applicants in paraellel to the refinement of the PKT intervention. A formal PKT programme will not be used prior to surgery in the MAT arm, although we will not discount people having prior or current physiotherapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Participant-reported knee function at 24 months, post randomisation, using the four-domain version of the Knee Injury and Osteoarthritis Outcome score (KOOS4). 2. To assess the cost effectiveness of MAT compared to PKT from an NHS and Personal, Social Service (PSS) perspective measured using health utility, occupational status, sports participant, mental wellbeing, further surgery (treatment switching or secondary knee surgery), satisfaction with the outcome of treatment, participant global impression of change and adverse events at three (EQ-5D 5L only), 6, 12, 18 and 24 months after randomisation |
| Secondary outcome measures | 1. KOOS4 at baseline, pre-intervention, 6, 12, 18 and 24 months post randomisation. 2. EQ-5D 5L at baseline, pre-intervention, 6, 12, 18 and 24 months post randomisation. 3. The five individual KOOS domain at baseline, 6, 12, 18 and 24 months post randomisation. 4. International Knee Documentation Committee subjective score (IKDC) at baseline and 24 months post randomisation. 5. Short Warwick-Edinburgh Mental Wellbeing Scale at baseline, 6, 12, 18 and 24 months post randomisation. 6. Tegner activity/sport scale at baseline, 6, 12, 18 and 24 months post randomisation. 7. Satisfaction with the outcome of treatment at 6, 12, 18 and 24 months post randomisation. 8. Patient global impression of change at 6, 12, 18 and 24 months post randomisation. 9. Adverse events at 6, 12, 18 and 24 months post randomisation. 10. Further knee surgery at 6, 12, 18 and 24 months post randomisation. 11. Health resource use at baseline, 6, 12, 18 and 24 months post randomisation. 12. Analgesia use at baseline, 6, 12, 18 and 24 months post randomisation. |
| Overall study start date | 01/06/2022 |
| Overall study end date | 30/11/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 144 |
| Participant inclusion criteria | 1.Pain and/or functional restrictions from the knee, severe enough to warrant potential MAT in the judgement of the treating clinician 2. Previous meniscectomy more than 6 months ago |
| Participant exclusion criteria | 1. Symptomatic ligament instability, not previously corrected, as determined by the assessing clinician 2. Coronal limb alignment which requires surgical correction, (previous correction, performed at least 6 months before entry to the trial, is not an exclusion criteria), as determined by the assessing clinician 3. Age under 16 years, or if ≥16, open growth plate at the proximal tibia as judged by the clinical team on imaging taken as part of standard care 4. Full thickness cartilage loss (exposed bone) >1 cm2 on routine clinical MRI, prior surgery, or any other form of clinical imaging or evaluation. This will be determined by the assessing clinician (it could be based on an assessment by a clinician or a radiologist, although the final decision rests with the treating clinician) 5. Inflammatory arthritis affecting the study knee as determined by the assessing clinician (i.e., a prior inflammatory event not considered to be related to the current clinical condition would not require exclusion) 6. Unable or unwilling to engage with rehabilitation 7. Unable to adhere to trial processes 8. Previous randomisation in the present trial (i.e., other knee). Where a previous randomisation has occurred in error, a participant may be withdrawn and this criterion will not apply |
| Recruitment start date | 01/11/2022 |
| Recruitment end date | 31/03/2025 |
Locations
Countries of recruitment
- Australia
- Belgium
- Canada
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Coventry
CV2 2DX
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
London
NW1 2PG
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Rotherham
S60 2UD
United Kingdom
Monkscourt Avenue
Airdrie
ML6 0JS
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Stanmore
HA7 4LP
United Kingdom
Northfield
Birmingham
B31 2AP
United Kingdom
Headington
Oxford
OX3 7HE
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Appley Bridge
Wigan
WN6 9EP
United Kingdom
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Clydebank
G81 4DY
United Kingdom
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
St Leonards
Sydney
NSW 2065
Australia
St Leonards
Sydney
NSW 2065
Australia
Brisbane City
Brisbane
QLD 4000
Australia
London
SW1X 7HY
United Kingdom
Sponsor information
University/education
Research and Impact Services
University House
Coventry
CV4 7AL
England
United Kingdom
| Phone | +44 24 7675733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | https://warwick.ac.uk/fac/sci/med/research/ctu/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
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 | 01/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Dissemination to patients and the public will be led in conjunction with our patient partners, who have been closely involved throughout the study development. Dissemination to trial participants will follow current HRA guidelines and Warwick SOP 22 on publication & dissemination (https://www.hra.nhs.uk/planning-and-improvingresearch/best-practice/publication-and-dissemination-research-findings/). We will use lay summaries and infographics which will be sent to trial participants (participants permission for this will be obtained at baseline), trial hospitals, and published on our trial website, or in conjunction with the main publication, if journal policies allow. Trial participants will be informed of the results using lay summaries and infographics on publication of the primary outcome results, we will follow current Health Research Authority guidelines in delivering this. We will prepare articles in magazines such as Arthritis Today, patient focused websites such as patient.co.uk and utilise social media to report our findings. We will use press releases to alert the popular press in conjunction with our press officer. A trial website will be hosted by WCTU and used to promote study progress and trial publications. |
| IPD sharing plan | De-identified data that underlie the results reported in the study will be available for non-commercial use, up to one year after publication of the primary outcome trial findings, or from metadata stored in a university repository up to 10 years without investigator support. To access trial data, third parties must complete a data-sharing agreement with the sponsors, have an ethically approved protocol in place for use of the data, and agree the approved protocol with the MeTeOR2 TMG. Data may be used for commercial purposes, according to the conditions above, but will need specific agreements in place prior to access being agreed, this may include a license fee. Analyses may include individual patient data meta-analyses or other purposes as agreed with the MeTeOR2 TMG. Available data will include (but is not exclusive to) de-identified individual participant data that underlies the results reported in trial publications, the study protocol, statistical analysis plan, master copy of the informed consent sheets and analytic codes used. After a year following the publication of the final report, the data will be stored in an appropriate repository, it may still be available according to the conditions laid out above but may not receive investigator support. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 03/08/2022 | 02/09/2022 | No | Yes |
| Participant information sheet | version 2 | 10/11/2022 | 25/05/2023 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 3 | 14/11/2023 | 06/02/2024 | No | Yes |
| Protocol file | version 2 | 01/08/2023 | 06/02/2024 | No | No |
| Protocol article | 03/06/2024 | 04/06/2024 | Yes | No |
Additional files
Editorial Notes
02/01/2025: The following study participating centres were added: Golden Jubilee National Hospital, The Royal Wolverhampton NHS Trust, Royal North Shore Hospital, North Shore Private Hospital, Brisbane Private Hospital and Cleveland Clinic London.
04/06/2024: Publication reference added.
20/05/2024: The following changes were made to the trial record:
1. The contact was changed.
2. the study participating centre Queen Elizabeth University Hospital was added.
06/02/2024: Participant information sheet and protocol uploaded. Royal Orthopaedic Hospital, Nuffield Orthopaedic Centre, Royal Devon University Healthcare NHS Foundation Trust and Wrightington Hospital were added to the study participating centres.
07/09/2023: NHS Lanarkshire Health Board, Gloucestershire Hospitals NHS Foundation Trust and Royal National Orthopaedic Hospital NHS Trust were added to the study participating centres.
25/05/2023: The following changes were made to the study record:
1. Contact details updated.
2. Belfast Health and Social Care Trust, University College London Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, North Bristol NHS Trust and The Rotherham NHS Foundation Trust were added to the study participating centres.
3. Participant information sheet uploaded.
03/10/2022: Internal review.
02/09/2022: Trial's existence confirmed by NHS HRA.
