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
Femoroacetabular impingement (FAI) is a common cause of hip pain in the young adult. Uncertainty regarding surgical indications, outcome assessment, management preferences and perceptions of the literature exist. We conducted a large international survey assessing the perceptions and demographics of orthopaedic surgeons regarding FAI. A survey was developed using previous literature, focus groups and a sample-to-redundancy strategy. The survey contained forty-six questions and was emailed to national orthopaedic associations and orthopaedic sports medicine societies for member responses. Members were contacted on multiple occasions to increase response rates. Nine hundred orthopaedic surgeons from twenty national and international organisations completed the survey. Surgeons responded across 6 continents, 58.2 % from developed nations with 35.4 % having sports fellowship training. North American and European surgeons reported significantly greater exposure to hip arthroscopy during residency and fellowships in comparison to international respondents (48.0% vs. 44.5% vs. 25.6% respectively; p<0.001). Surgeons performing a higher volume of FAI surgery (over 100 cases per year) were significantly more likely to have practiced for more than 20 years (OR 1.91; 95% CI 1.01 to 3.63), be practicing at an academic hospital (OR 2.25; 95% CI 1.22 to 4.15), and have formal arthroscopy training (OR 46.17; 95% CI 20.28 to 105.15). High volume surgeons were over two-fold more likely to practice in North America and Europe (OR 2.26; 95% CI: 1.08 to 4.72). The exponential rise in the diagnosis and surgical management for FAI appears to be driven largely by experienced surgeons in developed nations. Our analysis suggests that although FAI management is early in the innovation cycle we are at a tipping point towards wider uptake and utilisation. The results of this survey will help guide further research and study.
The Radiographic Union Score for Hip (RUSH) is an outcome instrument designed to describe radiographic healing of femoral neck fractures. The ability to identify fractures that have not healed is important for defining non-union in clinical trials and predicting patients that likely require additional surgery to promote fracture healing. We sought to determine a RUSH threshold score that defines nonunion at 6-months post-injury. Our secondary objective was to determine if this threshold was associated with increased risk for non-union surgery. A sample of 248 patients with adequate six-month hip radiographs and complete two-year clinical follow-up were analysed from a multi-national hip fracture trial (FAITH). All patients had a femoral neck fracture and were treated with either multiple cancellous screws or a sliding hip screw. Two reviewers independently determined the RUSH score based on the six-month post-injury radiographs, and agreement was assessed using the Interclass Correlation Coefficient (ICC). Fracture healing was determined by two independent methods: 1) prospectively by the treating surgeon using clinical and radiographic assessments, and 2) retrospectively by a Central Adjudication Committee using radiographs alone. Receiver Operator Curve analysis was used to define a RUSH threshold score that was specific for fracture nonunion. RUSH score inter-rater agreement was high (ICC: 0.81, 95% CI 0.76 to 0.85). The mean six-month RUSH score for all included patients was 24.4 (SD 3.4). A threshold score of <18 was associated with a greater than 98% specificity for nonunion. Furthermore, patients with a six-month RUSH score below 18 were more the seven-times more likely to require revision surgery for nonunion (Relative Risk: 7.25, 95% CI 2.62 to 20.00). The six-month RUSH score can effectively be used to communicate when a femoral neck fracture has not healed. The validity of our conclusions was further supported by the increased risk of nonunion surgery for patients below the RUSH threshold. We believe our findings can standardise a definition of nonunion for clinical trials and recommend the use of the RUSH and its <18-point threshold when describing femoral neck nonunion.
Level of evidence (LOE) determination is a reliable tool to assess the strength of research based on study design. Improvements in LOE are necessary for the advancement of evidence-based clinical care. The objectives of this study were to determine if the LOE presented at the Musculoskeletal Tumour Society (MSTS) annual meeting has improved over time and to determine how the LOE presented at MSTS annual meetings compares to that of the Orthopaedic Trauma Association (OTA) annual meetings. We reviewed abstracts from the MSTS and OTA annual meeting podium presentations from 2005 to 2014. Three independent reviewers evaluated a total of 1222 abstracts for study type and LOE. Changes in the distributions of study type and LOE over time were evaluated by Pearson Chi-Squared test. There were a total of 577 podium abstracts from the MSTS and 645 from the OTA. Of the MSTS therapeutic studies, 0.5% (2/376) were level I, while 75% (281/376) were level IV. There was a seven-fold higher proportion of level I studies (3.4% [14/409]) and less than half as many level IV studies (32% [130/409]) presented at OTA. There was no improvement in the MSTS LOE for all study types (p=0.13) and therapeutic study types (p=0.36) over the study decade. In contrast, the OTA LOE increased significantly over this time period for all study types (p<0.01). The proportion of controlled therapeutic studies (LOE I through III) versus uncontrolled studies (LOE IV) increased significantly over time at the OTA (p<0.021), but not at the MSTS (p=0.10). Uncontrolled case series continue to dominate the MSTS scientific program, whereas over the past decade, higher-level studies and more modern study methodology has been employed by members of the OTA.
Electrical stimulators are commonly used to accelerate fracture healing, resolve nonunions or delayed unions, and to promote spinal fusion. The efficacy of electrical stimulator treatment, however, remains uncertain. We conducted a meta-analysis of randomised sham-controlled trials to establish the effectiveness of electrical stimulation for bone healing. We searched MEDLINE, EMBASE, CINAHL and Cochrane Central to identify all randomised sham-controlled trials evaluating electrical stimulators in patients with acute fractures, non-union, delayed union, osteotomy healing or spinal fusion, published up to February 2015. Our outcomes were radiographic nonunion, patient-reported pain and self-reported function. Two reviewers independently assessed eligibility and risk of bias, performed data extraction, and rated overall confidence in the effect estimates according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Fifteen randomised trials met our inclusion criteria. Electrical stimulation reduced the relative risk of radiographic nonunion or persistent nonunion by 35% (95%CI 19% to 47%; 15 trials; 1247 patients; number needed to treat = 7; p < 0.01; moderate certainty). Electrical stimulation also showed a significant reduction in patient-reported pain (Mean Difference (MD) on the 100-millimeter visual analogue scale = −7.67; 95% CI −13.92 to −1.43; 4 trials; 195 patients; p = 0.02; moderate certainty). Limited functional outcome data showed no difference with electrical stimulation (MD −0.88; 95% CI −6.63 to 4.87; 2 trials; 316 patients; p = 0.76; low certainty). Patients treated with electrical stimulation as an adjunct for bone healing have a reduced risk of radiographic nonunion or persistent nonunion and less pain; functional outcome data are limited and requires increased focus in future trials.
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:
We carried out a systematic review of the literature
to evaluate the evidence regarding the clinical results of the Ilizarov
method in the treatment of long bone defects of the lower limbs. Only 37 reports (three non-randomised comparative studies, one
prospective study and 33 case-series) met our inclusion criteria.
Although several studies were unsatisfactory in terms of statistical
heterogeneity, our analysis appears to show that the Ilizarov method
of distraction osteogenesis significantly reduced the risk of deep
infection in infected osseous lesions (risk ratio 0.14 (95% confidence
interval (CI) 0.10 to 0.20), p <
0.001). However, there was a
rate of re-fracture of 5% (95% CI 3 to 7), with a rate of neurovascular
complications of 2.2% (95% CI 0.3 to 4) and an amputation rate of
2.9% (95% CI 1.4 to 4.4).The data was generally not statistically
heterogeneous. Where tibial defects were >
8 cm, the risk of re-fracture
increased (odds ratio 3.7 (95% CI 1.1 to 12.5), p = 0.036). The technique is demanding for patients, illustrated by the voluntary
amputation rate of 1.6% (95% CI 0 to 3.1), which underlines the
need for careful patient selection. Cite this article:
There has been a paradigm shift in orthopaedic research, it is now recognized that the extent to which interventions really make a difference to a patient's overall life is indicated by measuring one's general health status. The primary aim of this study was to report how the methodology of current evidence in hip fracture research can improve if studies included patients with cognitive impairment. Using multiple databases inclusive from 1990 to May 2009, we performed a systematic review of all hip fracture observational cohorts and randomized studies (RCTs).Introduction
Materials and methods
We explored the role of patients beliefs and attitudes towards their likelihood of recovery from severe physical trauma. We developed and validated an instrument designed to capture the impact of patients beliefs and attitudes towards functional recovery from injury; the Somatic Pre-Occupation and Coping (SPOC) questionnaire. At six weeks post-surgical fixation, we administered the SPOC questionnaire to 359 consecutive patients with operatively managed tibial shaft fractures. We constructed multi-variable regression models to explore the association between SPOC scores and functional outcome at one year, as measured by return to work and Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) scores.Purpose
Method
The recent emergence of autologous blood concentrates, such as platelet rich plasma (PRP), as a treatment option for patients with orthopaedic injuries has led to an extensive debate about their clinical benefit. Our objective was to determine the effectiveness of autologous blood concentrates compared with control therapy in improving pain in patients with orthopaedic bone and soft tissue injuries. We conducted a systematic review of MEDLINE and EMBASE from 1996 and 1947, respectively, up to July 2010. Additional studies were identified by contacting experts, searching the bibliographies of the included studies as well as orthopaedic meeting archives. We included published and unpublished randomized controlled trials or prospective cohort studies that compared autologous blood concentrates with a control therapy in patients with an orthopaedic injury. Two reviewers, working in duplicate, abstracted data on study characteristics and protocol. Reviewers resolved disagreement by consensus.Purpose
Method