Plain English Summary
Background and study aims
Osteoarthritis (OA) is the leading cause of disability worldwide and most commonly affects the knee joint causing issues with mobility, quality of life, and ability to work. Treatment options include non-surgical management and surgery may also be considered. Knee replacement is successful in patients over 60 years but less so if under 60 as the implant wears out sooner, therefore alternative options are sought to delay knee replacement surgery as long as possible. High tibial osteotomy (HTO), is a surgical procedure where the bone is cut just below the knee joint and a small wedge is opened, to shift the person’s weight away from the damaged part of the knee to a healthy part of the knee. This can decrease pain, improve function and delay or avoid the need for knee replacement. Personalised knee therapy (PKT) is a physiotherapist-delivered non-surgical focussed intervention consisting of a programme of exercise alongside exercise enabling pain relief (external braces if required) which aims to improve muscle control in the lower limb and knee joint, to shift weight away from the ‘worn’ part of the knee, help reduce pain and avoid the need for further surgery. In this study, the team want to find out if HTO is better at delaying or avoiding knee replacement surgery than PKT alone in patients under 60 years old by comparing these two interventions.
Who can participate?
Patients aged >18 and <60 years with old with symptomatic medial compartment knee OA who the treating orthopaedic surgeon considers a suitable candidate for medial opening wedge HTO
What does the study involve?
Patients will be enrolled at around 20 NHS hospitals in the UK to determine the clinical (pain relief, improvement in function, quality of life, return to work) and cost-effectiveness of both treatments at 24 months. A mixed method process evaluation in a subset of staff and patients will explore trial eligibility; recruitment and retention; acceptability of intervention implementation including trial processes and collection of routine monitoring data; patient experience of taking part and the contextual factors that influence this.
For participants randomised to the surgical group:
1. They will be placed on a routine NHS waiting list to have the HTO surgery
2. They will have their surgery at their local hospital and follow the local process for having the surgery and recovering from the operation. After their operation, they will receive standard postoperative rehabilitation from their hospital
For participants randomised to the non-surgical group:
1. They will be referred to the local NHS Physiotherapy department at the hospital and receive the specialised PKT physiotherapy programme of rehabilitation for knee OA
2. PKT will be delivered at their local NHS physiotherapy department over six sessions within a period of 3-4 months
Participants in both arms of the study will get the same questionnaires at 12 and 24 months post-randomisation (either via post or email) to assess whether these treatments have worked.
What are the possible benefits and risks of participating?
Both treatment options (non-surgical and surgical) have been proven in previous studies to improve knee pain, reduce disability and delay or avoid the need for a knee replacement altogether.
Non-surgical treatment has the obvious advantage that it does not require an operation and all the risks that go with an operation. The non-surgical treatment takes around 3-4 months to deliver and requires participants to attend at least six sessions with the physiotherapist and commit to the tailored exercise programme over this time. Participants may also be offered bracing and steroid injections. The treatment is directed at improving symptoms from osteoarthritis and does not alter the alignment of the lower leg.
Where is the study run from?
The lead study site is The Royal Infirmary of Edinburgh - NHS Lothian with the trial management team in Edinburgh Clinical Trials Unit - University of Edinburgh.
When is the study starting and how long is it expected to run for?
August 2022 to July 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact for the study?
Mr Anish Amin (Chief Investigator), Anish.K.Amin@ed.ac.uk (UK)
Study website
Contact information
Type
Principal Investigator
Contact name
Mr Anish Amin
ORCID ID
http://orcid.org/0000-0002-9768-7595
Contact details
Department of trauma and orthopaedic surgery
Room S4334 (c/o Medical Secretary)
Royal Infirmary of Edinburgh
51 Little France crescent
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 6881
Anish.K.Amin@ed.ac.uk
Type
Public
Contact name
Miss Rachel Penman
ORCID ID
http://orcid.org/0000-0003-0297-6851
Contact details
University of Edinburgh
level 2
NINE Edinburgh BioQuarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
+44 (0)131 651 9970
r.penman@ed.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
306571
ClinicalTrials.gov number
Nil known
Protocol/serial number
NIHR129820, CPMS 55238, IRAS 306571
Study information
Scientific title
What is the clinical-effectiveness and cost-effectiveness of surgery with medial opening wedge high tibial osteotomy (HTO) compared with non-surgical treatment in the management of osteoarthritis (OA) of the knee in patients younger than 60 years?
Acronym
MOTION Trial
Study hypothesis
Determine whether the intervention is superior to the comparator by answering the following two research questions:
1. For patients aged <60 years old with medial compartment knee OA, what is the relative clinical effectiveness (pain relief, improvement in function, quality of life, return to work) of HTO compared with non-surgical management at 24 months?
2. For patients aged <60 years old with medial compartment knee OA, what is the relative cost-effectiveness of HTO compared to non-surgical management at 24 months and as modelled over a lifetime horizon?
Ethics approval(s)
Approved 16/01/2023, South Central - Hampshire B Research Ethics Committee (2 The Square, Temple Quay, Bristol, BS1 6PN, UK; +44 (0)207 104 8088, (0)20 7104 8289, (0)20 7104 8289; hampshireb.rec@hra.nhs.uk), ref: 22/SC/0446
Study design
Multi-centre prospective randomized open blinded endpoint (PROBE) parallel-group controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Home, Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Medial compartment knee osteoarthritis
Intervention
In this study, patients under 60 years old with knee OA who the treating orthopaedic surgeon considers a suitable candidate for medial opening wedge high tibial osteotomy (HTO) surgery will be selected to compare the two possible options (non-surgical versus HTO). Half of the participants will be randomised for surgery (HTO) and half will be randomised to undertake a personalised knee therapy (PKT) package. PKT consists of a core package of a progressive structured exercise programme and advice on pain management, lifestyle and if appropriate, weight management. If it falls within usual care, optional inclusion of additional manual therapy, steroid injection, insoles or bracing and treatment of any co-existing symptoms can be introduced. The package is delivered over a 12 – 16 week period and involves 6 face-to-face sessions of physiotherapy and a patient program of physiotherapy to complete at home. Patients will be asked to complete a diary to record their compliance with the programme and bring it along to each visit for the details to be recorded. Which of the two treatments patients will get will be decided by chance, using a computer - half the patients will get one treatment, and half will get the other.
To compare the interventions, we will ask patients about their pain, knee function, quality of life and ability to work before and after the treatment. The research will be carried out at the local hospital or institution where the patient would normally be seen and treated.
Intervention type
Mixed
Primary outcome measure
Patients' opinions about their knee and associated problems measured using the patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 months
Secondary outcome measures
1. Fidelity of interventions measured using the minimum requirements/acceptable variation (MRAV) proforma completed between 6 -12 months post-intervention (note that this interval may be different from the same period post-randomisation due to NHS waiting lists)
2. Patients' opinions about their knee and associated problems measured using the patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months post-randomisation.
3. Symptoms, pain, ADLs, sports/recreation, and quality of life measured using five separate KOOS subscales at 12- and 24-months post-randomisation
4. Function and pain measured using the Oxford Knee score (OKS) at 12 and 24- months post-randomisation
5. Artificial prosthesis awareness during daily activities measured using the Forgotten Joint Score-12 (FJS-12) at 12- and 24- months post-randomisation
6. Health-related quality of life measured using the EuroQol EQ-5D-5L score (EQ-5D-5L – EQ-5D) at 12- and 24- months post-randomisation
7. Sleep quality measure using the Pittsburgh Sleep Quality Index (PSQI) at 12- and 24-months post-randomisation
8. Employment status measured using a bespoke Return to Work/Employment Questionnaire developed at the lead centre at 12 and 24 months post-randomisation
9. Additional study-knee-related operative intervention measured using patient medical records at 12- and 24-months post-randomisation
10. Intraoperative and postoperative complications measured using patient medical records at 12 and 24 months post-randomisation
11. Health Economic Evaluation Outcomes derived from the EQ-5D score at 12- and 24- months post-randomisation
11.1. Health and social care resource utilisation and associated NHS and personal social services (PSS) cost and Quality Adjusted life years (QALY) at 24 months
11.2. Incremental Cost per QALY at 24 months
11.3. NHS and PSS cost, and QALYs as modelled over a lifetime horizon to account for future impacts on the need for TKR and associated revision surgery and their timing relative to retirement
11.4. Incremental Cost per QALY as modelled over a lifetime horizon to account for future impacts on the need for TKR and associated revision surgery and their timing relative to retirement
Overall study start date
01/08/2022
Overall study end date
31/07/2027
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient aged <60 years old with symptomatic medial compartment knee OA who the treating orthopaedic surgeon considers a suitable candidate for medial opening wedge HTO
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
60 Years
Sex
Both
Target number of participants
224
Participant exclusion criteria
1. Aged <18 or >60 years old
2. Body mass index (BMI) >40
3. Patients considered for HTO but who DO NOT have any knee OA including:
3.1. Offloading HTO for concomitant cartilage repair (No OA)
3.2. Offloading HTO solely to treat ligamentous instability (ACL/PCL)
3.3. Symptomatic avascular necrosis/osteonecrosis
3.4. Correction of intraarticular or extraarticular post-traumatic knee deformity
4. Patients requiring double-level knee osteotomy for correction of deformity
5. History of inflammatory arthropathy including rheumatoid arthritis, gout, psoriasis
6. Previous high tibial or distal femoral osteotomy in the same or contralateral knee
7. Previous knee replacement (partial or total) in the same or contralateral knee
8. Cognitive impairment or inability to consent.
9. Inability to comply with study procedures.
10. Previous history of septic arthritis in the knee
Recruitment start date
01/02/2023
Recruitment end date
31/01/2025
Locations
Countries of recruitment
England, Scotland, United Kingdom, Wales
Study participating centre
NHS Lothian
Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Study participating centre
NHS Greater Glasgow and Clyde
J B Russell House
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Study participating centre
NHS Fife
Hayfield House
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Study participating centre
NHS Grampian
Summerfield House
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Study participating centre
University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study participating centre
Leeds Teaching Hospitals NHS Trust
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study participating centre
North Bristol NHS Trust
Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Study participating centre
Oxford University Hospitals
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Study participating centre
Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Study participating centre
South Tees Hospitals NHS Foundation Trust
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study participating centre
Royal Devon and Exeter Hospital
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study participating centre
Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Study participating centre
Lewisham and Greenwich NHS Trust
University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
Study participating centre
The Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom
Study participating centre
Warrington and Halton Teaching Hospitals NHS Foundation Trust
Warrington Hospital
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Study participating centre
Guys and St Thomas' NHS Foundation Trust
St Homas' Hospital
Westminster Bridge
London
SE1 7EH
United Kingdom
Study participating centre
East Suffolk and North Essex NHS Foundation Trust
Colchester Dist General Hospital
Turner Road
Colchester
CO4 5JL
United Kingdom
Study participating centre
St George's University Hospital NHS Foundation Trust
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Study participating centre
University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom
Study participating centre
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Gobowen
Oswestry
SY10 7AG
United Kingdom
Study participating centre
University Hospital Southampton
Southampton University Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study participating centre
Frimley Health NHS Foundation Trust
Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom
Study participating centre
Whiston Hospital (site)
Whiston Hospital
Warrington Road
Prescot
L35 5DR
United Kingdom
Study participating centre
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Study participating centre
Royal Berkshire NHS Foundation Trust
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
Study participating centre
Gateshead Health NHS Foundation Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Study participating centre
Cardiff & Vale University Lhb
Woodland House
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Study participating centre
Stockport NHS Foundation Trust
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Study participating centre
NHS Lanarkshire
14 Beckford Street
Hamilton
ML3 0TA
United Kingdom
Sponsor information
Organisation
University of Edinburgh
Sponsor details
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
None available
resgov@accord.scot
Sponsor type
University/education
Website
ROR
Organisation
NHS Lothian
Sponsor details
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
None available
accord@nhslothian.scot.nhs.uk
Sponsor type
Hospital/treatment centre
Website
http://www.nhslothian.scot.nhs.uk/Pages/default.aspx
ROR
Funders
Funder type
Government
Funder name
National Institute for Health and Care Research
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
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
The press will also be engaged through the University of Edinburgh press office. We may also use lay summaries and infographics which can be sent to trial participants, and trial hospitals, and published on our trial website, or in conjunction with the main publication, if journal policies allow. We will prepare articles for dissemination within magazines such as Arthritis Today and patient-focused websites such as https://www.patient.co.uk and https://www.versusarthritis.org.
Intention to publish date
31/07/2028
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 10/01/2023 | 25/01/2023 | No | Yes |
| Protocol file | version 2.0 | 06/12/2022 | 25/01/2023 | No | No |
| HRA research summary | 20/09/2023 | No | No |