Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA). This study is a secondary analysis of patients aged 50 years or older with a displaced femoral neck fracture who were enrolled in the HEALTH trial and underwent monopolar and bipolar HA. Scores from the Western Ontario and McMaster University Arthritis Index (WOMAC) and 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) and (MCS) were compared between the two HA groups using a propensity score-weighted analysis.Aims
Methods
To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials. This study included 2,388 patients from the HEALTH and FAITH trials, with 90-day and one-year mortality proportions of 3.0% (71/2,388) and 6.4% (153/2,388), respectively. The mean age was 75.9 years (SD 10.8) and 65.9% of patients (1,574/2,388) were female. The algorithms included patient and injury characteristics. Six algorithms were developed, internally validated and evaluated across discrimination (c-statistic; discriminative ability between those with risk of mortality and those without), calibration (observed outcome compared to the predicted probability), and the Brier score (composite of discrimination and calibration).Aims
Methods
The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population. We performed a post hoc exploratory analysis of a fitter cohort of patients from the HEALTH trial. Participants were aged over 50 years and had sustained a low-energy displaced femoral neck fracture (FNF). The fittest participant cohort was defined as participants aged 70 years or younger, classified as American Society of Anesthesiologists grade I or II, independent walkers prior to fracture, and living at home prior to fracture. Multilevel models were used to estimate the effect of THA versus HA on functional outcomes. In addition, a sensitivity analysis of the definition of the fittest participant cohort was performed.Aims
Methods
To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury.Aims
Methods
Artificial intelligence and machine-learning analytics have gained extensive popularity in recent years due to their clinically relevant applications. A wide range of proof-of-concept studies have demonstrated the ability of these analyses to personalize risk prediction, detect implant specifics from imaging, and monitor and assess patient movement and recovery. Though these applications are exciting and could potentially influence practice, it is imperative to understand when these analyses are indicated and where the data are derived from, prior to investing resources and confidence into the results and conclusions. In this article, we review the current benefits and potential limitations of machine-learning for the orthopaedic surgeon with a specific emphasis on data quality.
Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and debridement (I&D) and the development of subsequent deep infection has not been established in the literature. Traditionally, I&D of an open fracture has been recommended within six hours of injury based on animal studies from the 1970s, however the clinical basis for this remains unclear. Using data from a multicentre randomized controlled trial of 2,447 open fracture patients, the primary objective of this secondary analysis is to determine if a relationship exists between timing of wound I&D (within six hours of injury vs beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open limb fractures requiring surgical treatment. To adjust for the influence of patient and injury characteristics on the timing of I&D, a propensity score was developed from the dataset. Propensity-adjusted regression allowed for a matched cohort analysis within the study population to determine if early irrigation put patients independently at risk for reoperation, while controlling for confounding factors. Results were reported as odds ratios (ORs), 95% confidence intervals (CIs), and p-values. All analyses were conducted using STATA 14.Aims
Methods
Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery. The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trial examined adults with an open or closed tibial shaft fracture who were treated with either reamed or unreamed intramedullary nails. HRQoL was assessed at hospital discharge (for pre-injury level) and at 12 months post-fracture using the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction, SMFA Bother, 36-Item Short Form 36 (SF-36) Physical, and SF-36 Mental Component scores. We used multiple linear regression analysis to determine if baseline and surgical factors, as well as post-intervention procedures within one year of fracture, were associated with these HRQoL outcomes. Significance was set at p < 0.01. We hypothesize that, irrespective of the four measures used, prognosis is guided by both modifiable and non-modifiable factors and that patients do not return to their pre-injury level of function, nor HRQoL.Aims
Methods
The aims of this systematic review were to describe the quantity and methodological quality of meta-analyses in orthopaedic surgery published during the last 17 years. MEDLINE, EMBASE, and PubMed, between 1 January 2000 and 31 December 2016, were searched for meta-analyses in orthopaedic surgery dealing with at least one surgical intervention. Meta-analyses were included if the interventions involved a human muscle, ligament, bone or joint.Aims
Materials and Methods
The aims of this study were to quantify health state utility
values (HSUVs) after a tibial fracture, investigate the effect of
complications, to determine the trajectory in HSUVs that result
in these differences and to quantify the quality-adjusted life years
(QALYs) experienced by patients. This is an analysis of 2138 tibial fractures enrolled in the
Fluid Lavage of Open Wounds (FLOW) and Study to Prospectively Evaluate
Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT)
trials. Patients returned for follow-up at two and six weeks and
three, six, nine and 12 months. Short-Form Six-Dimension (SF-6D) values
were calculated and used to calculate QALYs.Aims
Patients and Methods
The primary aim of this prognostic study was to identify baseline
factors associated with physical health-related quality of life
(HRQL) in patients after a femoral neck fracture. The secondary
aims were to identify baseline factors associated with mental HRQL,
hip function, and health utility. Patients who were enrolled in the Fixation using Alternative
Implants for the Treatment of Hip Fractures (FAITH) trial completed
the 12-item Short Form Health Survey (SF-12), Western Ontario and
McMaster Universities Arthritis Index, and EuroQol 5-Dimension at
regular intervals for 24 months. We conducted multilevel mixed models
to identify factors potentially associated with HRQL. Aims
Patients and Methods
The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre,
blinded, randomized controlled trial that used a 2 × 3 factorial
design to evaluate the effect of irrigation solution (soap Participants completed the Short Form-12 (SF-12) and the EuroQol-5
Dimensions (EQ-5D) at baseline (pre-injury recall), at two and six
weeks, and at three, six, nine and 12-months post-fracture. We calculated
the Physical Component Score (PCS) and the Mental Component Score
(MCS) of the SF-12 and the EQ-5D utility score, conducted an analysis
using a multi-level generalized linear model, and compared differences
between the baseline and 12-month scores.Aims
Patients and Methods
The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF). The intraclass correlation coefficient (ICC) was used for test-retest reliability, between PROMs completed twice with a two-week interval at six to eight months after DRF. Internal consistency was determined using Cronbach’s α for the dimensions found in the factor analysis. The measurement error was expressed by the smallest detectable change (SDC). A semi-structured interview was conducted between eight and 12 weeks after DRF to assess the content validity.Objectives
Methods
This 501-patient, multi-centre, randomised controlled trial sought
to establish the effect of low-intensity, pulsed, ultrasound (LIPUS)
on tibial shaft fractures managed with intramedullary nailing. We
conducted an economic evaluation as part of this trial. Data for patients’ use of post-operative healthcare resources
and time taken to return to work were collected and costed using
publicly available sources. Health-related quality of life, assessed
using the Health Utilities Index Mark-3 (HUI-3), was used to derive
quality-adjusted life years (QALYs). Costs and QALYs were compared
between LIPUS and control (a placebo device) from a payer and societal
perspective using non-parametric bootstrapping. All costs are reported
in 2015 Canadian dollars unless otherwise stated.Aims
Patients and Methods
The diagnosis of surgical site infection following endoprosthetic reconstruction for bone tumours is frequently a subjective diagnosis. Large clinical trials use blinded Central Adjudication Committees (CACs) to minimise the variability and bias associated with assessing a clinical outcome. The aim of this study was to determine the level of inter-rater and intra-rater agreement in the diagnosis of surgical site infection in the context of a clinical trial. The Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial CAC adjudicated 29 non-PARITY cases of lower extremity endoprosthetic reconstruction. The CAC members classified each case according to the Centers for Disease Control (CDC) criteria for surgical site infection (superficial, deep, or organ space). Combinatorial analysis was used to calculate the smallest CAC panel size required to maximise agreement. A final meeting was held to establish a consensus.Objectives
Materials and Methods
Despite the fact that research fraud and misconduct are under scrutiny in the field of orthopaedic research, little systematic work has been done to uncover and characterise the underlying reasons for academic retractions in this field. The purpose of this study was to determine the rate of retractions and identify the reasons for retracted publications in the orthopaedic literature. Two reviewers independently searched MEDLINE, EMBASE, and the Cochrane Library (1995 to current) using MeSH keyword headings and the ‘retracted’ filter. We also searched an independent website that reports and archives retracted scientific publications (Objectives
Methods
Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making. A 29-question electronic survey was distributed to the readership of an established orthopaedic journal with international readership. The survey aimed to analyse the influence of both extrinsic (journal quality, investigator profiles, etc.) and intrinsic characteristics (study design, sample size, etc.) of research studies in relation to their influence on practice patterns.Objectives
Materials and Methods
Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies.Objectives
Methods
Current studies on the additional benefit of using computed tomography
(CT) in order to evaluate the surgeons’ agreement on treatment plans
for fracture are inconsistent. This inconsistency can be explained
by a methodological phenomenon called ‘spectrum bias’, defined as
the bias inherent when investigators choose a population lacking
therapeutic uncertainty for evaluation. The aim of the study is
to determine the influence of spectrum bias on the intra-observer
agreement of treatment plans for fractures of the distal radius. Four surgeons evaluated 51 patients with displaced fractures
of the distal radius at four time points: T1 and T2: conventional
radiographs; T3 and T4: radiographs and additional CT scan (radiograph
and CT). Choice of treatment plan (operative or non-operative) and
therapeutic certainty (five-point scale: very uncertain to very
certain) were rated. To determine the influence of spectrum bias,
the intra-observer agreement was analysed, using Kappa statistics,
for each degree of therapeutic certainty. Objectives
Methods
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
