MOTION Trial Protocol V1.0
Research type
Research Study
Full 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? (MOTION Trial)
IRAS ID
306571
Contact name
Anish K Amin
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
ISRCTN99042491
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
Osteoarthritis 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 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 need for further surgery.
In this randomised study, we want to find out if HTO is better at delaying or avoiding knee replacement surgery than PKT alone in patients under 60 years by comparing these two interventions. 224 patients(112 each arm) at around 20 NHS hospitals in the UK will 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.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0446
Date of REC Opinion
16 Jan 2023
REC opinion
Further Information Favourable Opinion