ISRCTN33276681
Active, not recruiting
未知
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 sites530 target enrollmentFebruary 27, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orth Bristol NHS Trust
- Enrollment
- 530
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38828864/ (added 04/06/2024)
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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