A randomised study to compare the outcomes after realignment knee surgery versus non-surgical treatment with bespoke knee physiotherapy, for patients under 60 years of age with osteoarthritis of the knee

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

Mr Anish Amin
Principal Investigator

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

ORCID ID	0000-0002-9768-7595
Phone	+44 (0)131 242 6881
Email	Anish.K.Amin@ed.ac.uk

Miss Rachel Penman
Public

University of Edinburgh
level 2, NINE Edinburgh BioQuarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom

ORCID ID	0000-0003-0297-6851
Phone	+44 (0)131 651 9970
Email	r.penman@ed.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Edinburgh
University/education

The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone	None available
Email	resgov@accord.scot
Website	http://www.ed.ac.uk/home
"ROR"	https://ror.org/01nrxwf90

NHS Lothian
Hospital/treatment centre

The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone	None available
Email	accord@nhslothian.scot.nhs.uk
Website	http://www.nhslothian.scot.nhs.uk/Pages/default.aspx
"ROR"	https://ror.org/03q82t418

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

43069 MOTION Protocol_v2.0_06Dec2022.pdf

43069 MOTION_PIS_v3.0_10Jan2023.pdf

Editorial Notes

17/04/2025:
11/04/2025: The recruitment end date was changed from 31/01/2025 to 01/04/2025. Royal Albert Edward Infirmary was removed from the study participating centres.
21/10/2024: The following changes were made:
1. Study website added.
2. Leeds Teaching Hospitals NHS Trust, North Bristol NHS Trust, Epsom and St Helier University Hospitals NHS Trust, South Tees Hospitals NHS Foundation Trust, Royal Devon and Exeter Hospital, Royal Albert Edward Infirmary, The Rotherham NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, University Hospital Southampton, Royal Berkshire NHS Foundation Trust, Gateshead Health NHS Foundation Trust, Cardiff & Vale University Lhb, and Stockport NHS Foundation Trust were removed from the Study participating centres.
3. Royal Albert Edward Infirmary, Kingston Hospital NHS Foundation Trust, Salisbury District Hospital, The Maidstone Hospital and Sunderland Royal Hospital were added to the the Study participating centres.
20/09/2023: A link to the HRA research summary was added.
18/01/2023: Trial's existence confirmed by NIHR (UK).