For people with pain after a meniscectomy, but without established OA, does a treatment strategy of undertaking MAT surgery or personalised knee therapy result in better clinical and/or cost effectiveness outcomes?
- Conditions
- Adults with knee pain and/or functional limitation following meniscectomy but without large areas of articular cartilage loss or established OA.Musculoskeletal Diseases
- Registration Number
- ISRCTN87336549
- Lead Sponsor
- niversity of Warwick
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38830746/ (added 04/06/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 144
1.Pain and/or functional restrictions from the knee, severe enough to warrant potential MAT in the judgement of the treating clinician
2. Previous meniscectomy more than 6 months ago
1. Symptomatic ligament instability, not previously corrected, as determined by the assessing clinician
2. Coronal limb alignment which requires surgical correction, (previous correction, performed at least 6 months before entry to the trial, is not an exclusion criteria), as determined by the assessing clinician
3. Age under 16 years, or if =16, open growth plate at the proximal tibia as judged by the clinical team on imaging taken as part of standard care
4. Full thickness cartilage loss (exposed bone) >1 cm2 on routine clinical MRI, prior surgery, or any other form of clinical imaging or evaluation. This will be determined by the assessing clinician (it could be based on an assessment by a clinician or a radiologist, although the final decision rests with the treating clinician)
5. Inflammatory arthritis affecting the study knee as determined by the assessing clinician (i.e., a prior inflammatory event not considered to be related to the current clinical condition would not require exclusion)
6. Unable or unwilling to engage with rehabilitation
7. Unable to adhere to trial processes
8. Previous randomisation in the present trial (i.e., other knee). Where a previous randomisation has occurred in error, a participant may be withdrawn and this criterion will not apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Participant-reported knee function at 24 months, post randomisation, using the four-domain version of the Knee Injury and Osteoarthritis Outcome score (KOOS4).<br>2. To assess the cost effectiveness of MAT compared to PKT from an NHS and Personal, Social Service (PSS) perspective measured using health utility, occupational status, sports participant, mental wellbeing, further surgery (treatment switching or secondary knee surgery), satisfaction with the outcome of treatment, participant global impression of change and adverse events at three (EQ-5D 5L only), 6, 12, 18 and 24 months after randomisation
- Secondary Outcome Measures
Name Time Method