During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.Aims
Methods
Hip bearing surfaces materials are typically broadly reported in national registry (metal-on-polyethylene, ceramic-on-ceramic etc). We investigated the revision rates of primary total hip replacement (THR) reported in the National Joint Registry (NJR) by detailed types of bearing surfaces used. We analysed THR procedures across all orthopaedic units in England and Wales. Our analyses estimated all-cause and cause-specific revision rates. We identified primary THRs with heads and monobloc cups or modular acetabular component THRs with detailed head and shell/liner bearing material combinations. We used flexible parametric survival models to estimate adjusted hazard ratios (HR). A total of 1,026,481 primary THRs performed between 2003–2019 were included in the primary analysis (Monobloc cups: n=378,979 and Modular cups: n=647,502) with 20,869 (2%) of these primary THRs subsequently undergoing a revision episode (Monobloc: n=7,381 and Modular: n=13,488). Compared to implants with a cobalt chrome head and highly crosslinked polyethylene (HCLPE) cup, the overall risk of revision for monobloc acetabular implant was higher for patients with cobalt chrome or stainless steel head and non-HCLPE cup. The risk of revision was lower for patients with a delta ceramic head and HCLPE cup implant, at any post-operative period. Compared to patients with a cobalt chrome head and HCLPE liner primary THR, the overall risk of revision for modular acetabular implant varied non-constantly. THRs with a delta ceramic or oxidised zirconium head and HCLPE liner had a lower risk of revision throughout the entire post-operative period. The overall and indication-specific risk of prosthesis revision, at different time points following the initial implantation, is reduced for implants with a delta ceramic or oxidised zirconium head and a HCLPE liner/cup in reference to THRs with a cobalt chrome head and HCLPE liner/cup.
Implants in total hip replacement (THR) are associated with different clinical and cost-effectiveness profiles,. We estimate the costs and outcomes for NHS patients in the year after THR associated with implant bearing materials using linked routinely collected data. We linked NJR primary elective THR patients for osteoarthritis to HES and National PROMs. We estimated health care costs, health-related quality of life indices, and revision risks, in the year after primary and revision THRs overall. We used generalised linear models adjusting for patient and hospital characteristics and estimated 10-year cumulative probability of revision. We imputed utilities using chained equations for half the sample with missing PROMS. We linked 577,973 elective primary THRs and 11,812 subsequent revisions. One year after primary THR, patients with the cemented THRs using cobalt chrome or stainless steel head with HCLPE liner/cup cost the NHS, on average, £13,101 (95%CI £13,080,£13,122), had an average quality-of-life score of 0.788 (95%CI 0.787,0.788), and a 10-year revision probability of 1.9% (95%CI 1.6,2.3). Compared to the reference, patients receiving a cemented THR with delta ceramic head and HCLPE liner/cup, hybrid THR with delta ceramic head and HCLPE liner/cup, and hybrid THR with alumina head and HCLPE liner/cup had lower 1-year costs (-£572 \[95% CI -£775,-£385\], -£346 \[-£501,-£192\], -£371 \[-£574,-£168\] respectively), better quality of life (0.007 \[95% CI 0.003,0.011\], 0.013 \[0.010,0.016\], 0.009 \[0.005,0.013\] respectively), and lower 10-year revision probabilities (1.4% \[1.03,2.0\], 1.5 \[1.3,1.7\], 1.6%\[1.2,2.1\] respectively). Implant bearing materials are associated with varying mean costs and health outcomes after primary THR. Ours is the first study to derive costs and health outcomes from large, linked databases using multiple imputation methods to deal with bias. Our findings are useful for commissioning and procurement decisions and to inform a subsequent cost-effectiveness model with more granular detail on THR implant types.
