Adults with knee pain and/or functional limitation following meniscectomy but without large areas of articular cartilage loss or established OA. Musculoskeletal Diseases
Conditions
Interventions
Participants are randomised to personalised knee therapy or meniscal transplant surgery. Participants will be randomly allocated (1:1) to the two treatment groups via a central computer-based randomis
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 years, 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 Where a previous randomisation has occurred in error, a participant may be withdrawn and this criterion will not apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participant-reported knee function at 24 months, post randomisation, using the four-domain version of the Knee Injury and Osteoarthritis Outcome score (KOOS4). 2. 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
| Measure | Time frame |
|---|---|
| 1. KOOS4 at baseline, pre-intervention, 6, 12, 18 and 24 months post randomisation. 2. EQ-5D 5L at baseline, pre-intervention, 6, 12, 18 and 24 months post randomisation. 3. The five individual KOOS domain at baseline, 6, 12, 18 and 24 months post randomisation. 4. International Knee Documentation Committee subjective score (IKDC) at baseline and 24 months post randomisation. 5. Short Warwick-Edinburgh Mental Wellbeing Scale at baseline, 6, 12, 18 and 24 months post randomisation. 6. Tegner activity/sport scale at baseline, 6, 12, 18 and 24 months post randomisation. 7. Satisfaction with the outcome of treatment at 6, 12, 18 and 24 months post randomisation. 8. Patient global impression of change at 6, 12, 18 and 24 months post randomisation. 9. Adverse events at 6, 12, 18 and 24 months post randomisation. 10. Further knee surgery at 6, 12, 18 and 24 months post randomisation. 11. Health resource use at baseline, 6, 12, 18 and 24 months post randomisation. 12. Analgesia use at baseline, 6, 12, 18 and 24 months post randomisation. | — |
Countries
Australia, England, Northern Ireland, Scotland, United Kingdom
Outcome results
None listed