Abstract
Abstract
Design
A pragmatic, multicentre, parallel-group, randomised controlled trial to determine whether the intervention is superior to comparator
Setting
20 NHS Hospitals
Population
NHS patients <60 years with moderate-severe symptomatic knee OA localised to the medial compartment in whom surgical intervention is indicated.
Intervention
Surgery with medial opening wedge high tibial osteotomy (HTO) followed by standard postoperative rehabilitation based on local pathways.
Comparator
Tailored non-surgical intervention delivered within an NHS physiotherapy department delivered over 6-contact sessions within a period of 4 months.
Outcomes
Primary outcome - 24-month Knee Injury and Osteoarthritis Outcome Score (KOOS); Secondary outcomes - OKS, FJS-12, EQ-5D-3L, Pittsburgh Sleep Problem Scale, Return to Work, secondary surgical interventions and complications at 12 and 24 months following randomisation. Health economic evaluation - 24-month within trial analysis, and 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. Process evaluation – to explore trial eligibility, recruitment and retention rates, acceptability of intervention implementation and patient experience of taking part/contextual factors that influence this.
Follow up
12 months and 24 months post-randomisation
Sample size
224 patients; (90% power, 2-sided p=0.05, equivalent to a sample size of 97 per group). Allowing for 15% loss to follow up, 112 patients will be recruited to each arm of the trial.
Project timelines
Start date 1 August 2022, total project duration 60 months including a 9-month, 5-site internal pilot, with a recruitment rate of 0.7 patients/site/month.
