Timing and duration of antibiotic prophylaxis is associated with the risk of infection after hip and knee arthroplasty

Aims: Antibiotic prophylaxis involving timely administration of appropriately dosed antibiotic is considered effective to reduce the risk of surgical site infection (SSI) after total hip and total knee arthroplasty (THA/TKA). Cephalosporins provide effective prophylaxis, although evidence regarding the optimal timing and dosage of prophylactic antibiotics is inconclusive. The aim of this study is to examine the association between cephalosporin prophylaxis dose, timing, and duration, and the risk of SSI after THA/TKA. Methods: A prospective multicentre cohort study was undertaken in consenting adults with osteoarthritis undergoing elective primary TKA/THA at one of 19 high-volume Australian public/private hospitals. Data were collected prior to and for one-year post surgery. Logistic regression was undertaken to explore associations between dose, timing, and duration of cephalosporin prophylaxis and SSI. Data were analyzed for 1,838 participants. There were 264 SSI comprising 63 deep SSI (defined as requiring intravenous antibiotics, readmission, or reoperation) and 161 superficial SSI (defined as requiring oral antibiotics) experienced by 249 (13.6%) participants within 365 days of surgery. Results: In adjusted modelling, factors associated with a significant reduction in any SSI and deep SSI included: correct weight-adjusted dose (any SSI; adjusted odds ratio (aOR) 0.68 (95% confidence interval (CI) 0.47 to 0.99); p = 0.045); commencing preoperative cephalosporin within 60 minutes (any SSI, aOR 0.56 (95% CI 0.36 to 0.89); p = 0.012; deep SSI, aOR 0.29 (95% CI 0.15 to 0.59); p < 0.001) or 60 minutes or longer prior to skin incision (aOR 0.35 (95% CI 0.17 to 0.70); p = 0.004; deep SSI, AOR 0.27 (95% CI 0.09 to 0.83); p = 0.022), compared to at or after skin incision. Other factors significantly associated with an increased risk of any SSI, but not deep SSI alone, were receiving a non-cephalosporin antibiotic preoperatively (aOR 1.35 (95% CI 1.01 to 1.81); p = 0.044) and changing cephalosporin dose (aOR 1.76 (95% CI 1.22 to 2.57); p = 0.002). There was no difference in risk of any or deep SSI between the duration of prophylaxis less than or in excess of 24 hours. Conclusion: Ensuring adequate, weight-adjusted dosing and early, preoperative delivery of prophylactic antibiotics may reduce the risk of SSI in THA/TKA, whereas the duration of prophylaxis beyond 24 hours is unnecessary

Is retrospective assessment of health-related quality of life valid?

Background: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patient-reported HRQoL before and after an intervening health event (elective orthopaedic surgery). Method: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at 2 weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson’s correlation. Agreement was tested in continuous variables using Lin’s coefficient of concordance (pc) and Bland-Altman plots. Results: One hundred seventy-four patients consented to participate. Eighty-eight paired prospective and retrospective scores were collected and there was a median between-test period of 15 days. At a group level, the prospective measurements were similar to the retrospective measurements; the modes and means of the five domain scores were not different and the mean differences (MD) between the scores for EQ-Index (MD = 0.02, on a scale of 0–1) and EQ-VAS (MD = 0.53, on a scale of 1–100) were negligible. However, the correlation of paired scores was varied; the range of domain score correlations was 0.52 to 0.74, the concordance was substantial for the EQ-Index scores (pc = 0.76, 95% CI = 0.66, 0.84) and moderate for the EQ-VAS scores (pc = 0.46, 95% CI = 0.28, 0.61). Conclusion: Agreement between prospective and retrospective measurements was high at a group level and moderate to substantial at an individual level. Retrospective measurement of HRQoL using the EQ-5D-5L in an orthopaedic clinical context is a valid alternative to using reference data to estimate baseline or pre-morbid health status

Feasibility and safety of combining repetitive transcranial magnetic stimulation and quadriceps strengthening exercise for chronic pain in knee osteoarthritis: A study protocol for a pilot randomised controlled trial

Introduction Knee osteoarthritis is a leading cause of disability, resulting in pain and reduced quality of life. Exercise is the cornerstone of conservative management but effects are, at best, moderate. Early evidence suggests that repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1) may improve the effect of exercise in knee osteoarthritis. This pilot study aims to (1) determine the feasibility, safety and participant-rated response to an intervention adding M1 rTMS to exercise in knee osteoarthritis; (2) elucidate physiological mechanisms in response to the intervention; (3) provide data to conduct a sample size calculation for a fully powered trial. Methods and analysis This is a pilot randomised, assessor-blind, therapist-blind and participant-blind, sham-controlled trial. Thirty individuals with painful knee osteoarthritis will be recruited and randomly allocated to receive either: (1) active rTMS+exercise or (2) sham rTMS+exercise intervention. Participants will receive 15 min of either active or sham rTMS immediately prior to 30 min of supervised muscle strengthening exercise (2×/week, 6 weeks) and complete unsupervised home exercises. Outcome measures of feasibility, safety, pain, function and physiological mechanisms will be assessed before and/or after the intervention. Feasibility and safety will be analysed using descriptive analysis. Within-group and between-group comparisons of pain and function will be conducted to examine trends of efficacy. Ethics and dissemination This study has been approved by the University of New South Wales Human Research Ethics Committee (HC210954). All participants will provide written informed consent. The study results will be submitted for peer-reviewed publication. Trial registration number ACTRN12621001712897p

Non-compliance with clinical guidelines increases the risk of complications after primary total hip and knee joint replacement surgery

Background Total hip and total knee replacement (THR/TKR) are common and effective surgeries to reduce the pain and disability associated with arthritis but are associated with small but significant risks of preventable complications such as surgical site infection (SSI) and venous-thrombo-embolism (VTE). This study aims to determine the degree to which hospital care was compliant with clinical guidelines for the prevention of SSI and VTE after THR/TKR; and whether non-compliant prophylaxis is associated with increased risk of complications. Methods and findings A prospective multi-centre cohort study was undertaken in consenting adults with osteoarthritis undergoing elective primary TKR/THR at one of 19 high-volume Australian public or private hospitals. Data were collected prior to surgery and for one-year post-surgery. Four adjusted logistic regression analyses were undertaken to explore associations between binary non-compliance and the risk of surgical complications: (1) composite (simultaneous) non-compliance with both (VTE and antibiotic) guidelines and composite complications [all-cause mortality, VTE, readmission/reoperation for joint-related reasons (one-year) and non-joint-related reasons (35-days)], (2) VTE non-compliance and VTE outcomes, (3) antibiotic non-compliance and any SSI, and (4) antibiotic non-compliance and deep SSI. Data were analysed for 1875 participants. Guideline non-compliance rates were high: 65% (VTE), 87% (antibiotics) and 95% (composite guideline). Composite non-compliance was not associated with composite complication (12.8% vs 8.3%, adjusted odds ratio [AOR] = 1.41, 95%CI 0.68–3.45, p = 0.40). Non-compliance with VTE guidelines was associated with VTE outcomes (5% vs 2.4%, AOR = 2.83, 95%CI 1.59–5.28,p < 0.001). Non-compliance with antibiotic guidelines was associated with any SSI (14.8% vs 6.1%, AOR = 1.98, 95%CI 1.17–3.62,p = 0.02) but not deep infection (3.7% vs 1.2%,AOR = 2.39, 95%CI 0.85–10.00, p = 0.15). Conclusions We found high rates of clinical variation and statistically significant associations between non-compliance with VTE and antibiotic guidelines and increased risk of VTE and SSI, respectively. Complications after THR/TKR surgery may be decreased by improving compliance with clinical guidelines

Compliance with Australian Orthopaedic Association guidelines does not reduce the risk of venous thromboembolism after total hip and knee arthroplasty

Preventing avoidable venous-thrombo-embolism (VTE) is a priority to improve patient and service outcomes after total hip and total knee arthroplasty (THA, TKA), but compliance with relevant clinical guidelines varies. This study aims to determine the degree to which prophylaxis was compliant with Australian Orthopaedic Association (AOA) VTE prophylaxis guidelines and whether non-compliance is associated with increased risk of VTE. A prospective multi-centre cohort study of adults with osteoarthritis undergoing primary TKA/THA was completed at 19 high-volume public and private hospitals. Data were collected prior to surgery and for one-year post-surgery. Logistic regression was undertaken to explore associations between non-compliance with AOA VTE prophylaxis guidelines and symptomatic 90-day VTE outcomes. Data were analysed for 1838 participants from 19 sites. The rate of non-compliance with all clinical guideline recommendations was 20.1% (N = 369), with 14.1% (N = 259) non-compliance for risk-stratified prophylaxis, 35.8% (N = 658) for duration, and 67.8% (N = 1246) for other general recommendations. Symptomatic VTE was experienced up to 90-days post-surgery by 48 people (2.6%). Overall guideline non-compliance (AOR = 0.93, 95%CI = 0.4 to 1.3, p = 0.86) was not associated with a lower risk of symptomatic 90-day VTE. Results were consistent when people with high bleeding risk were excluded (AOR = 0.94, 95%CI = 0.44 to 2.34, p = 0.89). Non-compliance with the AOA VTE prophylaxis guidelines was not associated with risk of 90-day VTE after arthroplasty. This counterintuitive finding is concerning and necessitates a rigorous review of the AOA VTE prevention clinical guideline

Associations between pre-surgical daily opioid use and short-term outcomes following knee or hip arthroplasty : a prospective, exploratory cohort study

Background: Retrospective studies have found that daily opioid use pre-arthroplasty predicts worse longer-term service, clinical and patient-reported outcomes. Prospective studies are needed to confirm these observations. This prospective, exploratory study aimed to determine: the proportion of total knee or hip arthroplasty (TKA, THA) patients who use opioids regularly (daily) pre-surgery; if opioid use pre-surgery is associated with acute and sub-acute outcomes to 12-weeks post-surgery. Methods: Consecutive patients undergoing primary TKA or THA were prospectively enrolled pre-surgery and followed-up by telephone to 12-weeks post-surgery. Acute-care (oral morphine equivalent dosage (OMED), length of stay, discharge to inpatient rehabilitation, complications) and 12-week outcomes (Oxford Knee or Hip Score, Euroqol 'today' health score, current use of opioids, and complications including readmissions) were monitored. Unadjusted and adjusted Odds Ratios (ORs) (95% Confidence Interval, CI), Rate Ratios and β coefficients (standard error) were calculated. Results: Five Hundred Twenty-One patients were included (TKA n = 381). 15.7% (95%CI 12.6 to 18.9) used opioids regularly pre-surgery. 86.8% (452/521) were available for follow-up at 12-weeks. In unadjusted analyses, pre-surgical opioid use was significantly associated with higher average acute daily OMED [β 0.40 (0.07), p < 0.001], presence of an acute complication [OR 1.75 (1.02 to 3.00)], and ongoing use of opioids at 12-weeks [OR 5.06 (2.86 to 8.93)]. After adjusting for covariates, opioid use pre-surgery remained significantly associated with average acute daily OMED [β 0.40 (0.07), p < 0.001] and ongoing use at 12-weeks [OR 5.38 (2.89 to 9.99)]. Conclusion: People who take daily opioids pre-surgery have significantly greater odds for greater opioid consumption acutely and ongoing use post-surgery. Adequately powered prospective studies are required to confirm whether pre-surgical opioid use is or is not associated with poorer joint and quality of life scores or a complication in the short-term

Association between VTE and antibiotic prophylaxis guideline compliance and patient-reported outcomes after total hip and knee arthroplasty : an observational study

Background: Surgical site infection (SSI) and venous thromboembolism (VTE) are associated with high burden and cost and are considered largely preventable following total knee or hip arthroplasty (TKA, THA). The risk of developing VTE and SSI is reduced when prophylaxis is compliant with evidence-based clinical guidelines. However, the association between VTE and antibiotic prophylaxis clinical guideline compliance and patient-reported outcome measures (PROMs) after THA/TKA is unknown. This study aims to explore whether care that is non-compliant with VTE and antibiotic guideline recommendations is associated with PROMs (Oxford Hip/Knee Score and EQ-5D Index scores) at 90- and 365-days after surgery. Methods: This prospective observational study included high-volume arthroplasty public and private sites and consenting eligible participants undergoing elective primary THA/TKA. We conducted multiple linear regression and linear mixed-effects modelling to explore the associations between non-compliance with VTE and antibiotic guidelines, and PROMs. Results: The sample included 1838 participants. Compliance with VTE and antibiotic guidelines was 35% and 13.2% respectively. In adjusted modelling, non-compliance with VTE guidelines was not associated with 90-day Oxford score (β = − 0.54, standard error [SE] = 0.34, p = 0.112) but was significantly associated with lower (worse) 365-day Oxford score (β = − 0.76, SE = 0.29, p = 0.009), lower EQ-5D Index scores at 90- (β = − 0.02 SE = 0.008, p = 0.011) and 365-days (β = − 0.03, SE = 0.008, p = 0.002). The changes in Oxford and EQ-5D Index scores were not clinically important. Noncompliance with antibiotic guidelines was not associated with either PROM at 90- (Oxford: β = − 0.45, standard error [SE] = 0.47, p = 0.341; EQ-5D: β = − 0.001, SE = 0.011, p = 0.891) or 365-days (Oxford score: β = − 0.06, SE = 0.41, p = 0.880 EQ-5D: β = − 0.010, SE = 0.012, p = 0.383). Results were consistent when complications were included in the model and in linear mixed-effects modelling with the insurance sector as a random effect. Conclusions: Non-compliance with VTE prophylaxis guidelines, but not antibiotic guidelines, is associated with statistically significant but not clinically meaningful differences in Oxford scores and EQ-5D Index scores at 365 days

Implementing early mobilisation after knee or hip arthroplasty to reduce length of stay : a quality improvement study with embedded qualitative component

Background: Models of care for managing total knee or hip arthroplasty (TKA, THA) incorporating early mobilisation are associated with shorter acute length-of-stay (LOS). Few studies have examined the effect of implementing early mobilisation in isolation, however. This study aimed to determine if an accelerated mobilisation protocol implemented in isolation is associated with a reduced LOS without undermining care. Method: A Before-After (quasi-experimental) study was used. Standard practice pre-implementation of the new protocol was physiotherapist-led mobilisation once per day commencing on post-operative Day 1 (Before phase). The new protocol (After phase) aimed to mobilise patients four times by end of Day 2 including an attempt to commence on Day 0; physiotherapy weekend coverage was necessarily increased. Poisson regression modelling was used to determine associations between study period and LOS. Additional outcomes to 12 weeks post-surgery were monitored to identify unintended consequences of the new protocol. Time to first mobilisation (hours) and proportion mobilising Day 0 were monitored to assess protocol compliance. An embedded qualitative component captured staff perspectives of the new protocol. Results: Five hundred twenty consecutive patients (n = 278, Before; n = 242, After) were included. The new protocol was associated with no change in unadjusted LOS, a small reduction in adjusted LOS (8.1%, p = 0.046), a reduction in time to first mobilisation (28.5 (10.8) vs 22.6 (8.1) hrs, p < 0.001), and an increase in the proportion mobilising Day 0 (0 vs 7%, p < 0.001). Greater improvements were curtailed by an unexpected decrease in physiotherapy staffing (After phase). There were no significant changes to the rates of complications or readmissions, joint-specific pain and function scores or health-related quality of life to 12 weeks post-surgery. Qualitative findings of 11 multidisciplinary team members highlighted the importance of morning surgery, staffing, and well-defined roles. Conclusion: Small reductions in LOS are possible utilising an early mobilisation protocol in isolation after TKA or THA although staff burden is increased likely undermining both sustainability and the magnitude of the change. Simultaneous incorporation of other changes within the pathway would likely secure larger reductions in LOS

Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study

OBJECTIVES: To determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statemen