Total knee replacement with patellar resurfacing compared to selective patellar resurfacing Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older 2. Elective primary Total Knee Replacement (TKR) for primary Osteoarthritis (OA) 3. Resident of England (English postcode) and surgery in an NHS England hospital
Exclusion criteria
Exclusion criteria: 1. Revision TKR 2. Unicompartmental knee replacement 3. Primary TKR with: 3.1. need for constrained implants (e.g., constrained condylar or hinge), 3.2. isolated patellofemoral OA, 3.3. history of septic arthritis, 3.4. diagnosis other than primary OA 4. Intra-operative patellar thickness insufficient for safe patellar resurfacing as determined by the treating surgeon (patellar thickness will be recorded in the case report forms for monitoring purposes) 5. Patient unable/unwilling to adhere to trial procedures 6. Patient unable to provide written informed consent. 7. Participating in another study that may affect the outcomes of this trial or that does not permit co-enrolment in another study or where co-enrolment would be burdensome to the patient. This will be assessed on a case-by-case basis by the local PI, in consultation with the co-CIs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxford Knee Score (OKS) questionnaire 1 year after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported questionnaires at 3 months, 6 months and 1 year post randomisation: 1. Oxford Knee Score 2. Knee Injury & Osteoarthritis Outcome Score 3. EQ-5D-5L Quality of health questionnaire Resource data will be collected at 3 months, 6 months and 1 year post randomisation, specifically: 4. Postoperative complications 5. Need for further surgery 6. Further patella resurfacing surgery 7. Resource use and costs within 1 year 8. Mortality data | — |
Countries
England, United Kingdom