The Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2)

Background Pain and disability after meniscectomy can be a substantial lifelong problem. Many of those affected are young and are severely impacted. They may also develop osteoarthritis (OA). Increasingly, surgeons are doing meniscal allograft transplants (MATs) for such people to reduce pain and improve function. This is thought to improve joint loading, reduce pain, and may prevent OA. However, MAT is expensive (around £7,500/case, totalling >£2M each year in the UK) and its clinical and cost-effectiveness are unproven. Non-surgical care including physiotherapy may be cheaper, safer and could be as or more effective. A randomised trial is urgently needed to determine which strategy is best for patients. Research Question For people with pain after a meniscectomy but without established OA, does a decision to do MAT or best non-surgical care result in better clinical and/or cost effectiveness outcomes? Design A two-arm multi-centre pragmatic RCT of MAT compared to best non-surgical care, with internal pilot. Health technologies MAT and post-operative physiotherapy versus a package of best non-surgical care called personalised knee therapy (PKT). Target Population Inclusion criteria: Pain and/or functional restriction from the knee, severe enough to warrant potential MAT; meniscectomy more than six months ago. Exclusion criteria: Symptomatic ligament instability not previously corrected; Coronal limb alignment requiring surgical correction (previous correction is not an exclusion criteria); age under 16; full thickness cartilage loss >1cm2 on MRI; inflammatory arthritides; unable or unwilling to engage with rehabilitation; unable to adhere to trial processes. Outcomes These have been established in close partnership with patients throughout study development. Primary outcome: The four-domain Knee Osteoarthritis Outcome Score (KOOS4) at 24-months after randomisation, a well-established knee specific instrument. Secondary Outcomes (baseline, 6, 12, 18 and 24 months after randomisation): All five KOOS domains, International Knee Documentation Committee subjective score, EQ-5D-5L (also at 3-months), Short Warwick-Edinburgh Mental Wellbeing Scale, Tegner activity/sport scale, work status (time off, change to work status), satisfaction, patient global impression of change, adverse events, further knee surgery and resource use. Sample size We will recruit 144 participants over 29 months to detect a 10 point difference in the KOOS4 score with 90% power and 5% significance, assuming 20% loss to follow-up. The first 12 months of recruitment will be used to assess study recruitment, time to intervention and intervention compliance. Impact and dissemination The results of this trial will have an important impact on patients for whom there are few good treatment options at present. MAT may be an effective solution, but if it is not then patients will avoid painful surgery with associated risks, and major savings will be made by stopping this expensive intervention. Clinical and cost-effectiveness results will be presented in high-impact journals and clinical conferences. With our PPI team members we will produce lay summaries and disseminate through patient organisations, on websites, and on social media. We will inform policy makers such as NICE. By delivering and disseminating a robust trial, we will ensure that the best care is offered for this under-researched patient group both in the UK and internationally.