The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing. A pragmatic multicentre randomised controlled Trial with blinding (PART)

orth Bristol NHS Trust0 个研究点目标入组 530 人开始时间: 2023年2月27日最近更新: 2024年6月18日

试验速览

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38828864/ (added 04/06/2024)

•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

•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.

发起方

orth Bristol NHS Trust