This study shows promising early results with very low wear, even for 36 mm heads, but long term follow-up is necessary to evaluate if this polyethylene will provide low wear and good mechanical properties in the long-term.
IntroductionThe current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA).Methods and analysisA minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason including aseptic loosening at 1, 6, 10 and 20 years of follow-up; patient-related outcome measures like function, pain, satisfaction and health-related quality of life at 1, 6 and 10 years of follow-up; risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1, 6, 10 and 20 years of follow-up; cost-effectiveness of routine ALBC versus plain bone cement use in primary TKA. We will use 1:1 randomisation with random permuted blocks and stratify by participating hospitals to randomise patients to receive ALBC or plain bone cement. Inclusion, randomisation and follow-up will be through the Norwegian Arthroplasty Register.Ethics and disseminationThe trial was approved by the Western Norway Regional Committees on Medical and Health Research Ethics (reference number: 2019/751/REK vest) on 21 June 2019. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberNCT04135170.
Background and purpose Reverse hybrid hip replacement uses a cemented all-polyethylene cup and an uncemented stem. Despite increasing use of this method in Scandinavia, there has been very little documentation of results. We have therefore analyzed the results from the Norwegian Arthroplasty Register (NAR), with up to 10 years of follow-up.Patients and methods The NAR has been collecting data on total hip replacement (THR) since 1987. Reverse hybrid hip replacements were used mainly from 2000. We extracted data on reverse hybrid THR from this year onward until December 31, 2009, and compared the results with those from cemented implants over the same period. Specific cup/stem combinations involving 100 cases or more were selected. In addition, only combinations that were taken into use in 2005 or earlier were included. 3,963 operations in 3,630 patients were included. We used the Kaplan-Meier method and Cox regression analysis for estimation of prosthesis survival and relative risk of revision. The main endpoint was revision for any cause, but we also performed specific analyses on different reasons for revision.Results We found equal survival to that from cemented THR at 5 years (cemented: 97.0% (95% CI: 96.8–97.2); reverse hybrid: 96.7% (96.0–97.4)) and at 7 years (cemented: 96.0% (95.7–96.2); reverse hybrid: 95.6% (94.4–96.7)). Adjusted relative risk of revision of the reverse hybrids was 1.1 (0.9–1.4). In patients under 60 years of age, we found similar survival of the 2 groups at 5 and 7 years, with an adjusted relative risk of revision of reverse hybrids of 0.9 (0.6–1.3) compared to cemented implants.Interpretation With a follow-up of up to 10 years, reverse hybrid THRs performed well, and similarly to all-cemented THRs from the same time period. The reverse hybrid method might therefore be an alternative to all-cemented THR. Longer follow-up time is needed to evaluate whether reverse hybrid hip replacement has any advantages over all-cemented THR.
We investigated mechanisms resulting in low bone mineral density (BMD) and susceptibility to fracture by comparing noncoding RNAs (ncRNAs) in biopsies of non–weight‐bearing (NWB) iliac (n = 84) and weight bearing (WB) femoral (n = 18) postmenopausal bone across BMDs varying from normal (T‐score > −1.0) to osteoporotic (T‐score ≤ −2.5). Global bone ncRNA concentrations were determined by PCR and microchip analyses. Association with BMD or fracture, adjusted by age and body mass index, were calculated using linear and logistic regression and least absolute shrinkage and selection operator (Lasso) analysis. At 10% false discovery rate (FDR), 75 iliac bone ncRNAs and 94 femoral bone ncRNAs were associated with total hip BMD. Eight of the ncRNAs were common for the two sites, but five of them (miR‐484, miR‐328‐3p, miR‐27a‐5p, miR‐28‐3p, and miR‐409‐3p) correlated positively to BMD in femoral bone, but negatively in iliac bone. Of predicted pathways recognized in bone metabolism, ECM‐receptor interaction and proteoglycans in cancer emerged at both sites, whereas fatty acid metabolism and focal adhesion were only identified in iliac bone. Lasso analysis and cross‐validations identified sets of nine bone ncRNAs correlating strongly with adjusted total hip BMD in both femoral and iliac bone. Twenty‐eight iliac ncRNAs were associated with risk of fracture (FDR < 0.1). The small nucleolar RNAs, RNU44 and RNU48, have a function in stabilization of ribosomal RNAs (rRNAs), and their association with fracture and BMD suggest that aberrant processing of rRNAs may be involved in development of osteoporosis. Cis‐eQTL (expressed quantitative trait loci) analysis of the iliac bone biopsies identified two loci associated with microRNAs (miRNAs), one previously identified in a heel‐BMD genomewide association study (GWAS). In this comprehensive investigation of the skeletal genetic background in postmenopausal women, we identified functional bone ncRNAs associated to fracture and BMD, representing distinct subsets in WB and NWB skeletal sites. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
Wear of this vitamin E-infused highly cross-linked polyethylene is still low at 6-year follow-up, with no significant difference in wear from 3 months to 6 years between 32- and 36-mm heads.
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