Limb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours.
Methods and analysis
This is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibiotic-related adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05.
Ethics and dissemination
This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients’ lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow.
Manufacturers of implants and materials in the field of orthopaedics use significant amounts of funding to produce informational material to influence the decision-making process of orthopaedic surgeons with regards to choice between novel implants and techniques. It remains unclear how far orthopaedic surgeons are really influenced by the materials supplied by companies or whether other, evidence-based publications have a higher impact on their decision-making. The objective was to evaluate the subjective usefulness and usage of different sources of information upon which orthopaedic surgeons base their decisions when acquiring new implants or techniques.
We undertook an online survey of 1174 orthopaedic surgeons worldwide (of whom n = 305 were head of their department). The questionnaire included 34 items. Sequences were randomized to reduce possible bias. Questions were closed or semi-open with single or multiple answers. The usage and relevance of different sources of information when learning about and selecting orthopaedic treatments were evaluated. Orthopaedic surgeons and trainees were targeted, and were only allowed to respond once over a period of two weeks. Baseline information included country of workplace, level of experience and orthopaedic subspecialisation. The results were statistically evaluated.
Independent scientific proof had the highest influence on decisions for treatment while OEM (Original Equipment Manufacturer) driven activities like newsletters, white papers or workshops had the least impact. Comparison of answers from the three best-represented countries in this study (Germany, UK and USA) showed some significant differences: Scientific literature and congresses are significantly more important in the US than in the UK or Germany, although they are very important in all countries.
Independent and peer-reviewed sources of information are preferred by surgeons when choosing between methods and implants. Manufacturers of medical devices in orthopaedics employ a considerable workforce to inform or influence hospital managers and leading doctors with marketing activities. Our results indicate that it might be far more effective to channel at least some of these funds into peer-reviewed research projects, thereby assuring significantly higher acceptance of the related products.
Orthopaedics; Survey; Decision-making process; Evidence-based medicine; Online evaluation; Opinion; Internet-based
Despite the prominence of hip fractures in orthopedic trauma, the assessment of fracture healing using radiographs remains subjective. The variability in the assessment of fracture healing has important implications for both clinical research and patient care. With little existing literature regarding reliable consensus on hip fracture healing, this study was conducted to determine inter-rater reliability between orthopedic surgeons and radiologists on healing assessments using sequential radiographs in patients with hip fractures. Secondary objectives included evaluating a checklist designed to assess hip fracture healing and determining whether agreement improved when reviewers were aware of the timing of the x-rays in relation to the patients’ surgery.
A panel of six reviewers (three orthopedic surgeons and three radiologists) independently assessed fracture healing using sequential radiographs from 100 patients with femoral neck fractures and 100 patients with intertrochanteric fractures. During their independent review they also completed a previously developed radiographic checklist (Radiographic Union Score for Hip (RUSH)). Inter and intra-rater reliability scores were calculated. Data from the current study was compared to the findings from a previously conducted study where the same reviewers, unaware of the timing of the x-rays, completed the RUSH score.
The agreement between surgeons and radiologists for fracture healing was moderate for “general impression of fracture healing” in both femoral neck (ICC = 0.60, 95% CI: 0.42-0.71) and intertrochanteric fractures (0.50, 95% CI: 0.33-0.62). Using a standardized checklist (RUSH), agreement was almost perfect in both femoral neck (ICC = 0.85, 95% CI: 0.82-0.87) and intertrochanteric fractures (0.88, 95% CI: 0.86-0.90). We also found a high degree of correlation between healing and the total RUSH score using a Receiver Operating Characteristic (ROC) analysis, there was an area under the curve of 0.993 for femoral neck cases and 0.989 for intertrochanteric cases. Agreement within the radiologist group and within the surgeon group did not significantly differ in our analyses. In all cases, radiographs in which the time from surgery was known resulted in higher agreement scores compared to those from the previous study in which reviewers were unaware of the time the radiograph was obtained.
Agreement in hip fracture radiographic healing may be improved with the use of a standardized checklist and appears highly influenced by the timing of the radiograph. These findings should be considered when evaluating patient outcomes and in clinical studies involving patients with hip fractures. Future research initiatives are required to further evaluate the RUSH checklist.
Hip fractures; Reliability; Fracture healing; Radiographs
To perform a systematic review and individual participant data meta-analysis to identify preoperative factors associated with a good seizure outcome in children with Tuberous Sclerosis Complex undergoing resective epilepsy surgery.
Electronic databases (MEDLINE, EMBASE, CINAHL and Web of Science), archives of major epilepsy and neurosurgery meetings, and bibliographies of relevant articles, with no language or date restrictions.
We included case-control or cohort studies of consecutive participants undergoing resective epilepsy surgery that reported seizure outcomes. We performed title and abstract and full text screening independently and in duplicate. We resolved disagreements through discussion.
One author performed data extraction which was verified by a second author using predefined data fields including study quality assessment using a risk of bias instrument we developed. We recorded all preoperative factors that may plausibly predict seizure outcomes.
To identify predictors of a good seizure outcome (i.e. Engel Class I or II) we used logistic regression adjusting for length of follow-up for each preoperative variable.
Of 9863 citations, 20 articles reporting on 181 participants were eligible. Good seizure outcomes were observed in 126 (69%) participants (Engel Class I: 102(56%); Engel class II: 24(13%)). In univariable analyses, absence of generalized seizure semiology (OR = 3.1, 95%CI = 1.2–8.2, p = 0.022), no or mild developmental delay (OR = 7.3, 95%CI = 2.1–24.7, p = 0.001), unifocal ictal scalp electroencephalographic (EEG) abnormality (OR = 3.2, 95%CI = 1.4–7.6, p = 0.008) and EEG/Magnetic resonance imaging concordance (OR = 4.9, 95%CI = 1.8–13.5, p = 0.002) were associated with a good postoperative seizure outcome.
Small retrospective cohort studies are inherently prone to bias, some of which are overcome using individual participant data. The best available evidence suggests four preoperative factors predictive of good seizure outcomes following resective epilepsy surgery. Large long-term prospective multicenter observational studies are required to further evaluate the risk factors identified in this review.
Intimate partner violence (IPV) is a serious health issue. There have been widespread research efforts in the area of IPV over the past several decades, primarily focusing on obstetrics, emergency medicine, and primary care settings. Until recently there has been a paucity of research focusing on IPV in surgery, and thus a resultant knowledge gap. Renewed interest in the underlying risk of IPV among women with musculoskeletal injuries has fueled several important studies to determine the nature and scope of this issue in orthopaedic surgery. Our review summarizes the evidence from surgical research in the field of IPV and provides recommendations for developing and evaluating an IPV identification and support program and opportunities for future research.
Intimate partner violence; Domestic violence; Identification program; Orthopaedic surgery; Musculoskeletal injury
The assessment of post-surgical outcomes among patients with Workers’ Compensation is challenging as their results are typically worse compared to those who do not receive this compensation. These patients’ time to return to work is a relevant outcome measure as it illustrates the economic and social implications of this phenomenon. In this meta-analysis we aimed to assess the influence of this factor, comparing compensated and non-compensated patients.
Two authors independently searched MEDLINE (Ovid), Embase (Ovid), CINAHL, Google Scholar, LILACS and the Cochrane Library and also searched for references from the retrieved studies. We aimed to find prospective studies that compared carpal tunnel release and elective rotator cuff surgery outcomes for Workers’ Compensation patients versus their non-compensated counterparts. We assessed the studies’ quality using the Guyatt & Busse Risk of Bias Tool. Data collection was performed to depict included studies characteristics and meta-analysis. Three studies were included in the review. Two of these studies assessed the outcomes following carpal tunnel release while the other focused on rotator cuff repair. The results demonstrated that time to return to work was longer for patients that were compensated and that there was a strong association between this outcome and compensation status - Standard Mean Difference, 1.35 (IC 95%; 0.91-1.80, p < 0.001).
This study demonstrated that compensated patients have a longer return to work time following carpal tunnel release and elective rotator cuff surgery, compared to patients who did not receive compensation. Surgeons and health providers should be mindful of this phenomenon when evaluating the prognosis of a surgery for a patient receiving compensation for their condition.
Type of study/level of evidence
Meta-analysis of prospective Studies/ Level III
Workers’ compensation; Hand surgery; Outcomes; Carpal tunnel syndrome; Rotator cuff tears; Systematic review; Time to return to work
Intimate partner violence (IPV) is an important health issue. Many medical students and residents have received training relating to IPV, but previous studies show that many students feel that their training has been inadequate. Our objective was to assess the knowledge, attitudes and perceptions about IPV among university medical students and surgical residents.
We administered an online survey to a sample of Ontario medical students and surgical residents. The survey instrument was a modified version of the Provider Survey.
Two hundred medical students and surgical residents participated in the survey (response rate: 29%). Misperceptions about IPV among respondents included the following: 1) victims must get something from the abusive relationships (18.2%), 2) physicians should not interfere with a couple’s conflicts (21%), 3) asking about IPV risks offending patients (45%), 4) Victims choose to be victims (11.1%), 5) it usually takes ‘two to tango’ (18.3%), and 6) some patients’ personalities cause them to be abused (41.1%). The majority of respondents (75.0%) believed identifying IPV was very relevant to clinical practice. The majority of medical students (91.2%) and surgical residents (96.9%) estimated the IPV prevalence in their intended practice to be 10% or less. Most of the medical students (84%) and surgical residents (60%) felt that their level of training on IPV was inadequate and over three quarters of respondents (77.2%) expressed a desire to receive additional education and training on IPV.
There are misconceptions among Canadian medical students and surgical residents about intimate partner violence. These misconceptions may stem from lack of education and personal discomfort with the issue or from other factors such as gender. Curricula in medical schools and surgical training programs should appropriately emphasize educational opportunities in the area of IPV.
Intimate Partner Violence; Violence prevention; Cross-sectional survey; Medical education
Previous reviews have demonstrated that patient outcomes following orthopaedic surgery are strongly influenced by the presence of Workers’ Compensation. However, the variability in the reviews’ methodology may have inflated the estimated strength of this association. The main objective of this meta-analysis is to evaluate the influence of Workers’ Compensation on the outcomes of orthopaedic surgical procedures.
We conducted a systematic search of the literature published in this area from 1992–2012, with no language restrictions. The following databases were used MEDLINE (Ovid), Embase (Ovid), CINAHL, Google Scholar, LILACS and Pubmed. We also hand-searched the reference sections of all selected papers. We included all prospective studies evaluating the effect of compensation status on outcomes in adult patients who had undergone surgery due to orthopaedic conditions or diseases. Outcomes of interest included disease specific, region specific and/or overall quality of life scales/questionnaires and surgeons’ personal judgment of the results. We used an assessment tool to appraise the quality of all included studies. We used Review Manager to create forest plots to summarize study data and funnel plots for the assessment of publication bias.
Twenty studies met our eligibility criteria. The overall risk ratio for experiencing an unsatisfactory result after orthopaedic surgery for patients with compensation compared to non-compensated patients is 2.08 (95% CI 1.54–2.82). A similar association was shown for continuous data extracted from the studies using assessment scales or questionnaires (Standard Mean Difference = −0.70 95% CI -0.97- −0.43).
Among patients who undergo orthopaedic surgical procedures, those receiving Workers’ Compensation experience a two-fold greater risk of a negative outcome. Our findings show a considerably lower estimate of risk compared to previous reviews that include retrospective data. Further research is warranted to determine the etiological explanation for the influence of compensation status on patient outcomes.
Systematic Review Registration Number
Surgery is indicated for symptomatic knee osteoarthritis (OA) when conservative measures are unsuccessful. High tibial osteotomy (HTO), unicompartmental knee arthroplasty (UKA), and total knee arthroplasty (TKA) are surgical options intended to relieve knee OA pain and dysfunction. The choice of surgical intervention is dependent on several factors such as disease location, patient age, comorbidities, and activity levels. Regardless of surgical treatment, complications such as infection, loosening or lysis, periprosthetic fracture, and postoperative pain are known risks and are indications for revision surgery. The clinical and economic implications for revision surgery are underappreciated. Over 55,000 revision surgeries were performed in 2010 in the US, with 48% of these revisions in patients under 65 years. Total costs associated with each revision TKA surgery have been estimated to be in excess of $49,000. The current annual economic burden of revision knee OA surgery is $2.7 billion for hospital charges alone. By 2030, assuming a 5-fold increase in the number of revision procedures, this economic burden will exceed $13 billion annually. It is appealing to envision a therapy that could delay or obviate the need for arthroplasty. From an actuarial standpoint, this would have the theoretical downstream effect of substantially reducing the number of revision procedures. Although no known therapies currently meet these criteria, such a breakthrough would have a tremendous impact in lessening the clinical and economic burden of knee OA revision surgery.
arthroplasty; knee; osteoarthritis; revision
Although there is general consensus about the efficacy of total hip replacement (THR) in young patients, the most appropriate bearings in young patients remain highly debated. The three most popular bearings in use include metal-on-polyethylene (MOP), metal-on-metal (MOM) and ceramic-on-ceramic (COC). We conducted a systematic review and meta-analysis of literature to summarise the best available evidence on relative success of the three most popular bearings used in THR in young active patients. Our findings support the use of MOM bearings in the management of the young arthritic hip. These findings, largely based upon observational studies, should be taken in the context of the limitations of such non-randomised study designs.
Background and purpose
Hip fractures are among the top causes of global disability. Conduction of high-quality studies such as randomized controlled trials to assess the effectiveness of interventions remains crucial. The geographic distribution of hip fracture studies is largely unknown. We wanted to make a global assessment of national contributions of randomized controlled trials on surgical interventions for hip fracture.
We performed a systematic search for randomized controlled trials on surgical interventions for hip fracture that were published from May 1970 to May 2011. Study information including sample size and study location was abstracted. The number of trials and cumulative sample size of hip fracture clinical trials were analyzed with respect to geographic region (city, country, and continent).
We identified 199 randomized trials investigating surgical interventions. Sweden ranked highest with 50 trials (8,941 patients). The United Kingdom followed with 40 trials (7,589 patients). Other countries contributed substantially less. The United States and Canada together contributed only a tenth of the total number of trials contributed by European countries.
Global contributions to randomized trials and the total number of patients recruited have been led by Scandinavian countries and the UK. Countries with few trials but a large burden of hip fractures have an opportunity to engage in high-quality research to resolve important surgical questions and improve the generalizability of study results.
Orthopaedic surgery is a high-risk specialty in which errors will undoubtedly occur. Patient safety incidents can yield valuable information to generate solutions and prevent future cases of avoidable harm. The aim of this study was to understand the causative factors leading to all unnecessary deaths in orthopaedics and trauma surgery reported to the National Patient Safety Agency (NPSA) over a four-year period (2005–2009), using a qualitative approach.
Reports made to the NPSA are categorised and stored in the database as free-text data. A search was undertaken to identify the cases of all-cause mortality in orthopaedic and trauma surgery, and the free-text elements were used for thematic analysis. Descriptive statistics were calculated based on the incidents reported. This included presenting the number of times categories of incidents had the same or similar response. Superordinate and subordinate categories were created.
A total of 257 incident reports were analysed. Four main thematic categories emerged. These were: (1) stages of the surgical journey – 118/191 (62%) of deaths occurred in the post-operative phase; (2) causes of patient deaths – 32% were related to severe infections; (3) reported quality of medical interventions – 65% of patients experienced minimal or delayed treatment; (4) skills of healthcare professionals – 44% of deaths had a failure in non-technical skills.
Most complications in orthopaedic surgery can be dealt with adequately, provided they are anticipated and that risk-reduction strategies are instituted. Surgeons take pride in the precision of operative techniques; perhaps it is time to enshrine the multimodal tools available to ensure safer patient care.
Patient safety; Errors; Orthopaedics; Trauma surgery; Quality improvement
Deep infection following endoprosthetic limb reconstruction for sarcoma of the long bones is a devastating complication occurring in 15% of sarcoma patients. Optimizing infection protocols and conducting definitive surgical trials are critical to improving outcomes. In this study, the PARITY (Prophylactic Antibiotic Regimens in Tumor Surgery) investigators aimed to examine surgeon preferences in antibiotic prophylaxis and perceptions about current evidence, as well as to ascertain interest in resolving uncertainty in the evidence with clinical trials.
We used a cross-sectional survey to examine current practice in the prescription of prophylactic antibiotics in Musculoskeletal Tumor Surgery. The survey was approved by our institution’s Ethics Board and emailed to all Active Members of the Musculoskeletal Tumor Society (MSTS) and Canadian Orthopaedic Oncology Society (CANOOS). Survey answers were collected using an anonymous online survey tool.
Of the 96 surgeons who received the questionnaire, 72 responded (75% response rate (% CI: 65.5, 82.5%)). While almost all respondents agreed antibiotic regimens were important in reducing the risk of infection, respondents varied considerably in their choices of antibiotic regimens and dosages. Although 73% (95% CI: 61, 82%) of respondents prescribe a first generation cephalosporin, 25% favor additional coverage with an aminoglycoside and/or Vancomycin. Of those who prescribe a cephalosporin, 33% prescribe a dosage of one gram for all patients and the reminder prescribe up to 2 grams based on body weight. One in three surgeons (95% CI: 25, 48%) believes antibiotics could be discontinued after 24 hours but 40% (95% CI: 30, 53%) continue antibiotics until the suction drain is removed. Given the ongoing uncertainty in evidence to guide best practices, 90% (95% CI: 81, 95%) of respondents agreed that they would change their practice if a large randomized controlled trial showed clear benefit of an antibiotic drug regimen different from what they are currently using. Further support for a clinical trial was observed by an overwhelming surgeon interest (87%; 95% CI: 77, 93%) in participating in a multi-center randomized controlled study.
The current lack of guidelines for the prescription of prophylactic antibiotics in Musculoskeletal Tumor Surgery has left Orthopaedic Oncologists with varying opinions and practices. The lack of current evidence and strong surgeon support for participating in a definitive study provides strong rationale for clinical trials.
Knowledge and training in evidence-based medicine (EBM) and clinical research is under-represented in most surgical training programs in North America. To address a lack of resources for surgeons, trainees and related specialties, we developed a Principles and Practice of Clinical Research (PPCR) course. The current study evaluated transfer of knowledge and perceptions about the course.
The course was an intensive 2.5-day workshop consisting of interactive lectures and small group breakout sessions. Pre- and postcourse tests were completed by participants. The Fresno test, questions from the Centre of Applied Medical Statistics (CAMS) test and questions developed by the course chairs were used to determine if participants’ knowledge of EBM, clinical research methodology and statistics improved. We also elicited participant perceptions of the course.
Overall participant knowledge about EBM and clinical research methods improved significantly from the pre- to the postcourse test (mean improvement in score 13.5%, relative increase 35.3%, p < 0.001). Specifically, improvements were demonstrated on the Fresno test (mean improvement 13.5%, relative increase 36.1%, p < 0.001) and the CAMS test (mean improvement 11.4%, relative increase 20.1%, p = 0.001). Participants showed the greatest improvement in general knowledge about clinical research (mean improvement 15.4%, relative increase 46.5%, p < 0.001). The PPCR course was well received; 30 (81.1%) participants who completed the course evaluation gave it a positive rating.
Participants in a short course focusing on EBM and clinical research methodology had significant improvements in scores on tests of knowledge gained. Widespread implementation of similar courses may bridge knowledge gaps for surgeons, surgical trainees and health professionals. Whether shorter knowledge gains are retained in the longer term remains unknown.
Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance.
Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates.
Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217).
In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy.
randomized controlled trial; management; trial coordinator; trial performance; inclusion; follow-up
Decision aids help physicians convey information to patients and enable patients to be involved in the decision-making process. There is a lack of use of decision aids in the orthopedic literature. The purpose of this study was to develop a decision board to elicit preferences for treatment of displaced femoral neck fractures in patients over 60 years old.
Materials and Methods:
We developed a decision board presenting descriptions and potential outcomes and complications of two treatment options, hemiarthroplasty (HA) and internal fixation (IF), for displaced femoral neck fractures. Five orthopedic surgeons evaluated the face and content validity of the decision board and 10 volunteers completed “scope tests” to determine the comprehensibility. We then presented the decision board to 108 study participants faced with the scenario of sustaining a displaced femoral neck fracture. Participants stated their preference for operative procedure and described the reasons for their choices.
The decision board achieved good face and content validity. All participants in the scope tests appropriately switched their preference to the other modality when probabilities were altered. Most participants found the decision board easy to understand and helpful in making an informed decision. Also, most participants were satisfied with the amount of information presented and with the use of the decision board as a decision making tool. Sixty-one participants (56%) chose IF as their operative procedure of choice quoting less blood loss, shorter operative time, and less invasiveness as the top factors that contributed to this choice. Participants who preferred HA (44%) did so primarily due to the lower re-operation rate.
The decision board is a useful and reliable tool to inform patients about the treatment options for displaced femoral neck fractures. They should be utilized by surgeons to incorporate patients’ preferences into the decision-making process.
Decision aid; decision board; femoral neck fracture; hemiarthroplasty; internal fixation
The optimal treatment of displaced femoral neck fractures in patients over 60 years is controversial. While much research has focused on the impact of total hip arthroplasty (THA) and hemiarthroplasty (HA) on surgical outcomes, little is known about patient preferences for either alternative. The purpose of this study was to elicit surgical preferences of patients at risk of sustaining hip fracture using a novel decision board.
We developed a decision board for the surgical management of displaced femoral neck fractures presenting risks and outcomes of HA and THA. The decision board was presented to 81 elderly patients at risk for developing femoral neck fractures identified from an osteoporosis clinic. The participants were faced with the scenario of sustaining a displaced femoral neck fracture and were asked to state their treatment option preference and rationale for operative procedure.
Eighty-five percent (85%) of participants were between the age of 60 and 80 years; 89% were female; 88% were Caucasian; and 49% had some post-secondary education. Ninety-three percent (93%; 95% confidence interval [CI], 87-99%) of participants chose THA as their preferred operative choice. Participants identified several factors important to their decision, including the perception of greater walking distance (63%), less residual pain (29%), less reoperative risk (28%) and lower mortality risk (20%) with THA. Participants who preferred HA (7%; 95% CI, 1-13%) did so for perceived less invasiveness (50%), lower dislocation risk (33%), lower infection risk (33%), and shorter operative time (17%).
The overwhelming majority of patients preferred THA to HA for the treatment of a displaced femoral neck fracture when confronted with risks and outcomes of both procedures on a decision board.
After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication.
We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials not completed by July 2009, and performed a systematic search for publications resulting from registered closed trials. Information regarding primary and secondary outcomes, intervention, study sponsors, and sample size were extracted from registrations and publications.
Of 130 closed trials, 37 eligible trials resulted in 16 publications (43.2%). We found no significant differences in publication rates between funding sources for industry sponsored studies and nongovernment/nonindustry sponsored studies (p > 0.05). About half the trials (45%) did not include the NCT ID in the publication. Two (10%) publications had major changes to the primary outcome measure and ten (52.6%) to sample size.
Registration of orthopaedic trauma trials does not consistently result in publication. When trials are registered, many do not cite NCT ID in the publication. Furthermore, changes that are not reflected in the registry of the trial are frequently made to the final publication.
Trial registration; Clinicaltrials.gov; Orthopaedic trauma
Radiographic healing is a common outcome measure in orthopedic trials and adjudication by outcome assessors is often conducted on the basis of plain films alone. The degree to which this process reflects clinical practice, in which both plain films and clinical notes are available, is uncertain. We explored the effect of adding clinical notes to radiographs in the adjudication process of a feasibility trial of tibial shaft fractures.
Radiographic and clinical data from a multicenter randomized controlled trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. At the completion of the trial, serial radiographs (anteroposterior and lateral) were independently evaluated for progression of fracture healing, defined as bridging of at least 3 of 4 cortices, by an adjudication committee comprised of 3 blinded orthopaedic trauma surgeons. Immediately after determination of radiographic time to healing, each surgeon was provided with clinical notes associated with each radiographic follow up visit and asked to re-visit their initial impression. Consensus was achieved for both adjudications. We calculated the percentage of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of clinical notes and their relative influence on the committee's decisions.
47 of 51 patients were determined to have healed radiographically during the trial follow-up period, and consideration of clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing. Clinical notes that resulted in a change to either a 'healed' or a 'not healed' decision contained significantly more comments of either pain resolution or deterioration, respectively, resumption of or failure to resume weightbearing, or either return or no return to work/pre-injury activities (p < 0.001).
The addition of clinical notes to the adjudication of radiographic fracture healing changed the outcome decision in a substantial number of cases. Orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing in order to enhance the generalizability of their results.
The TRUST trial was registered [ID NCT00667849] at http://clinicaltrials.gov/ct2/show/NCT00667849
There is increasing interest by chiropractors in North America regarding integration into mainstream healthcare; however, there is limited information about attitudes towards the profession among conventional healthcare providers, including orthopaedic surgeons.
We administered a 43-item cross-sectional survey to 1000 Canadian and American orthopaedic surgeons that inquired about demographic variables and their attitudes towards chiropractic. Our survey included an option for respondants to include written comments, and our present analysis is restricted to these comments. Two reviewers, independantly and in duplicate, coded all written comments using thematic analysis.
487 surgeons completed the survey (response rate 49%), and 174 provided written comments. Our analysis revealed 8 themes and 24 sub-themes represented in surgeons' comments. Reported themes were: variability amongst chiropractors (n = 55); concerns with chiropractic treatment (n = 54); areas where chiropractic is perceived as effective (n = 43); unethical behavior (n = 43); patient interaction (n = 36); the scientific basis of chiropractic (n = 26); personal experiences with chiropractic (n = 21); and chiropractic training (n = 18). Common sub-themes endorsed by surgeon's were diversity within the chiropractic profession as a barrier to increased interprofessional collaboration, endorsement for chiropractic treatment of musculoskeletal complaints, criticism for treatment of non-musculoskeletal complaints, and concern over whether chiropractic care was evidence-based.
Our analysis identified a number of issues that will have to be considered by the chiropractic profession as part of its efforts to further integrate chiropractic into mainstream healthcare.
orthopaedics; chiropractic; attitude of health personnel; survey