Off-label substitution therapy with a fibrinogen concentrate generally improved global laboratory coagulation results and as supplementary intervention, appeared to diminish the requirements for RBC, FFP, and platelet substitution in this patient cohort.
Objective
To investigate the effects of one and two doses of intravenous dexamethasone in patients after total knee arthroplasty.
Design
Randomised, blinded, placebo controlled trial with follow-up at 90 days.
Setting
Five Danish hospitals, September 2018 to March 2020.
Participants
485 adult participants undergoing total knee arthroplasty.
Intervention
A computer generated randomised sequence stratified for site was used to allocate participants to one of three groups: DX1 (dexamethasone (24 mg)+placebo); DX2 (dexamethasone (24 mg)+dexamethasone (24 mg)); or placebo (placebo+placebo). The intervention was given preoperatively and after 24 hours. Participants, investigators, and outcome assessors were blinded. All participants received paracetamol, ibuprofen, and local infiltration analgesia.
Main outcome measures
The primary outcome was total intravenous morphine consumption 0 to 48 hours postoperatively. Multiplicity adjusted threshold for statistical significance was P<0.017 and minimal important difference was 10 mg morphine. Secondary outcomes included postoperative pain.
Results
485 participants were randomised: 161 to DX1, 162 to DX2, and 162 to placebo. Data from 472 participants (97.3%) were included in the primary outcome analysis. The median (interquartile range) morphine consumptions at 0-48 hours were: DX1 37.9 mg (20.7 to 56.7); DX2 35.0 mg (20.6 to 52.0); and placebo 43.0 mg (28.7 to 64.0). Hodges-Lehmann median differences between groups were: −2.7 mg (98.3% confidence interval −9.3 to 3.7), P=0.30 between DX1 and DX2; 7.8 mg (0.7 to 14.7), P=0.008 between DX1 and placebo; and 10.7 mg (4.0 to 17.3), P<0.001 between DX2 and placebo. Postoperative pain was reduced at 24 hours with one dose, and at 48 hours with two doses, of dexamethasone.
Conclusion
Two doses of dexamethasone reduced morphine consumption during 48 hours after total knee arthroplasty and reduced postoperative pain.
Trial registration
Clinicaltrials.gov
NCT03506789
.
Background and purposeThe use of uncemented fixation in total hip arthroplasty (THA) is increasing. Registry studies have indicated an increased risk of revision of uncemented implants due to early periprosthetic femoral fracture. In this paper, we describe the incidence and predisposing factors for intraoperative and early postoperative (≤ 90 days) periprosthetic femoral fractures after cemented and uncemented THA.Patients and methodsThis was a prospective observational study in 8 Danish high-volume centers from February 2010 to November 2013. We used the 90-day follow-up from the Danish National Patient Registry and patient records. We obtained intraoperative information from the Danish Hip Arthroplasty Registry and from surgical notes.ResultsOf 7,169 primary consecutive THAs, 5,482 (77%) were performed using uncemented femoral components. The total incidence of periprosthetic femoral fractures ≤ 90 days postoperatively was 2.1% (n = 150). 70 fractures were detected intraoperatively (46 required osteosynthesis). 51 postoperatively detected fractures occurred without trauma (42 of which were reoperated) and 29 were postoperative fall-related fractures (27 of which were reoperated). 134 fractures (2.4%) were found in uncemented femoral components and 16 (0.9%) were found in cemented femoral components (p < 0.001). Uncemented femoral stem (relative risk (RR) = 4.1, 95% CI: 2.3–7.2), medically treated osteoporosis (RR =2.8, CI: 1.6–4.8), female sex (RR =1.6, CI: 1.1–2.2), and age (RR =1.4 per 10 years, CI: 1.2–1.6) were associated with increased risk of periprosthetic femoral fracture when analyzed using multivariable regression analysis.InterpretationUncemented femoral components were associated with an increased risk of early periprosthetic femoral fractures, especially in elderly, female, and osteoporotic patients.
We wished to evaluate whether inhibition of the systemic inflammatory response by a single pre-operative dose of methylprednisolone reduced markers of early endothelial damage after fast-track total knee arthroplasty. We randomly allocated 70 patients undergoing elective unilateral total knee arthroplasty (1:1) to receive either pre-operative intravenous methylprednisolone 125 mg (methylprednisolone group) or isotonic saline (control group). All procedures were performed under spinal anaesthesia without a tourniquet, using a standardised multimodal analgesic regime. The outcomes included changes in Syndecan-1 concentrations, a marker of glycocalyx degradation, markers of endothelial cell damage and activation (plasma soluble thrombomodulin and sE-Selectin), and permeability by vascular endothelial growth factor, as well as C-reactive protein concentrations. Blood samples were collected at baseline and 2 h, 6 h and 24 h after surgery, with complete sampling from 63 patients for analyses. Methylprednisolone significantly reduced markers of endothelial damage at 24 h following surgery compared with saline (methylprednisolone group vs. control group, adjusted means (SEM)) expressed by circulating Syndecan-1: 11.6 (1.0) ng.ml vs. 13.4 (1.1) ng.ml p = 0.046; soluble thrombomodulin: 5.1 (0.1) ng.ml vs. 5.7 (0.2) ng.ml , p = 0.009; sE-Selectin: 64.8 (1.8) ng.ml vs. 75.7 (1.9) ng.ml , p = 0.001, and vascular endothelial growth factor: 35.3 (2.7) ng.ml vs. 58.5 (2.8) ng.ml , p < 0.001. The effect of the intervention increased with time for soluble thrombomodulin, sE-Selectin and vascular endothelial growth factor, and was more pronounced in patients with high baseline values. Finally, methylprednisolone reduced the C-reactive protein response 24 h postoperatively; 31.1 (1.1) mg.l vs. 68.4 (1.1) mg.l , p < 0.001. Pre-operative administration of methylprednisolone 125 mg reduced circulating markers of endothelial activation and damage, as well as the systemic inflammatory response (C-reactive protein) early after fast-track total knee arthroplasty. These findings may have a positive effect on surgical outcome, but require studies in major surgery.
Fast-track THA and TKA with an LOS of median 3 days and discharge to home are feasible in most patients ≥85 years. However, further attention to pre- and postoperative anemia and the pathogenesis of medical complications is needed to improve postoperative outcomes and reduce readmissions.
If patients are carefully selected for BSTHA, the procedure appears to be safe when combined with a fast-track protocol in Denmark. We found significantly lower readmission rates and shorter total LOS in the BSTHA group compared with the BTHA groups, potentially reflecting selection bias. The results should stimulate to evaluate BSTHA in a randomised controlled trial or a detailed prospective, large multicenter study with a fast-track protocol regarding morbidity, convalescence and mortality.
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