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)

BACKGROUND Nearly 1 in 5 people >45 years in the UK suffer from pain and disability due to knee osteoarthritis (OA). This number is expected to increase dramatically over the next two decades. The James Lind Alliance designated the surgical and non-surgical options for the treatment of knee OA as a Top 10 Priority Setting Partnership in 2016. In patients >60 years with moderate-to-severe knee OA, surgery with knee replacement (partial or total) has been successful. However, in patients <60 years there is uncertainty regarding the most effective treatment (surgical or non-surgical) because knee replacement in these patients is associated with a high failure rate, poor patient reported outcome scores, low rates of return to work and high rates of redo knee replacement. If the knee OA mainly affects the medial compartment of the knee, realignment of the lower leg with high tibial osteotomy (HTO) can also relieve pain and improve function with the possibility of return to work. Since the native knee joint is preserved in HTO, it has the potential to be an effective surgical solution in active patients 60 years when results of knee replacement become more predictable. In a proportion of patients undergoing HTO surgery, knee replacement may be avoided altogether. However, surgical treatment with HTO has never been compared with non-surgical treatment. This trial is aimed at filling this evidence gap. RESEARCH QUESTIONS (1) For patients <60 years 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 <60 years 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? AIM The aim of this trial is to conduct a pragmatic, multicentre, randomised controlled trial to determine whether the intervention is superior to comparator. METHODS 224 patients will be recruited across 20 NHS sites and will be randomly assigned (1:1 ratio) to one of two treatment arms - surgical treatment with HTO or non surgical treatment. The PICO framework for the study is as follows: Population - NHS patients <60 years with symptomatic knee OA localised to the medial compartment in whom surgical intervention is indicated. Intervention - Surgery with medial opening wedge HTO followed by standard postoperative rehabilitation based on local pathways. Comparator - Non-surgical intervention with Personalised Knee Therapy (PKT) delivered within an NHS physiotherapy department. The PKT will be delivered within 6-contact sessions over a period not exceeding 4 months. A core package will focus on education and advice, pain moderation, structured exercise/rehabilitation with optional additional treatment of co-existing symptoms, manual therapy, use of steroid injections and bracing/orthotics based on local pathways. Outcomes - The primary outcome will be the 24-month Knee Injury and Osteoarthritis Outcome Score (KOOS). The secondary outcome measures will be the Oxford Knee Score, Forgotten Joint Score-12, EuroQol EQ-5D-3L score, Pittsburgh Sleep Problem Scale, Return to work/employment questionnaire, additional study knee related operative interventions, complications and health economic evaluation at 12 and 24 months following randomisation. For the health economic evaluation, two complimentary cost-effectiveness analyses will be performed: (1) A 24-month within trial analysis, and (2) A decision analytic simulation model to account for the impacts of future knee replacements (and associated revisions), and their timing relative to retirement and employment potential. An integrated mixed method process evaluation will assess the acceptability and feasibly of the intervention from staff and patients to add