Purpose

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.

Purpose

Conflict of interest reporting at annual orthopaedic surgical meetings aims to ensure transparency of surgeon-industry relationships. Increasing rigor in the reporting guidelines provides a unique opportunity to understand the impact of industry relationships in the conduct of orthopaedic research. We examined self-reported conflicts by surgeons presenting original research in arthroplasty and trauma meetings.

Purpose

Cross-linking of polyethylene greatly reduces its wear rate in hip simulator studies. We conducted a systematic review and meta-analysis of randomized controlled trials comparing cross-linked to conventional polyethylene liners for total hip arthroplasty to determine if there is a clinical reduction of: 1) wear rates, 2) radiographic osteolysis, and 3) need for total hip revision.

Purpose

Malrotation of the femur has been documented in as few as 0% and as many as 28% of fractures treated with an intramedullary(IM) nail. Patients with more than 15 degrees of malrotation sometimes require derotation osteotomy. Recognizing malrotation intraoperatively is the most efficient way to avoid corrective surgery. The purpose of this paper is to inform orthopaedic surgeons of the best estimate of incidence of femoral malrotation after IM nailing. This may lead to increased attention toward intraoperative control of malrotation.

Purpose

Using utilities and other outcome data collected prospectively on all SPRINT patients and cost data collected from a sample of SPRINT patients, we compared reamed and unreamed intramedullary nailing using a cost-utility analysis.

Purpose

The ability to correctly interpret quantitative results is a crucial skill developed in medical school and surgical residency. It demands a basic understanding of epidemiological principles and modes of presenting data. Yet, there has been little investigation into the efficacy of current teaching methods and areas of difficulty among orthopaedic residents.

Purpose

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.

Using inaccurate quotations can propagate misleading information, which might affect the management of patients. The aim of this study was to determine the predictors of quotation inaccuracy in the peer-reviewed orthopaedic literature related to the scaphoid. We randomly selected 100 papers from ten orthopaedic journals. All references were retrieved in full text when available or otherwise excluded. Two observers independently rated all quotations from the selected papers by comparing the claims made by the authors with the data and expressed opinions of the reference source. A statistical analysis determined which article-related factors were predictors of quotation inaccuracy. The mean total inaccuracy rate of the 3840 verified quotes was 7.6%. There was no correlation between the rate of inaccuracy and the impact factor of the journal. Multivariable analysis identified the journal and the type of study (clinical, biomechanical, methodological, case report or review) as important predictors of the total quotation inaccuracy rate.

We concluded that inaccurate quotations in the peer-reviewed orthopaedic literature related to the scaphoid were common and slightly more so for certain journals and certain study types. Authors, reviewers and editorial staff play an important role in reducing this inaccuracy.

Purpose: We aimed to preliminarily validate a newly developed system, the radiographic union scale for tibial (RUST) fracture healing. We hypothesized that RUST would demonstrate better inter-rater reliability than assessment of the number of cortices bridged and correlate with functional outcomes at least as strongly as surgeon’s assessment of cortical bridging.

Method: Three blinded orthopaedic trauma surgeons independently assigned a RUST score and a number of cortices bridged by callus (zero to four) to each set of AP and lateral radiographs at each follow up period. RUST is scored from four (definitely not healed) to 12 (definitely healed) based on the presence or absence of callus and of a visible fracture line at the total of four cortices visible.

Results: For 549 sets of reviewed radiographs, inter-rater reliability for RUST scores were found to be substantially higher than for assessment of the number of cortices bridged (intra-class correlation coefficient=0.84; 95% CI, 0.80–0.87 versus kappa = 0.73; 95% CI, 0.64 – 0.81, respectively). Both methods of assessing radiographic healing were strongly correlated with weight-bearing status (r and ρ> 0.50), moderately correlated with patient-reported functional recovery and the SF-36 Physical Functioning component scores (r and ρ> 0.30), and minimally correlated with HUI Mark II scores, return to work, and the SF-36 Role Physical component and Physical Component Summary scores (r and ρ> 0.10). Neither assessment was correlated with patient-reported pain scores. All correlations were similar for RUST and the number of cortices bridged.

Conclusion: This study provides preliminary evidence that RUST can be used as a valid and reliable alternative assessment of tibial fracture healing.

Purpose: To investigate

if adding the prospect of co-authorship to a survey’s final paper would increase, and

Method: We identified orthopaedic surgeons through the internet-based Orthopaedic Trauma Association member list. All surgeons received the same questionnaire. In a factorial randomized, controlled fashion, they were allocated

to receive or not receive an additional cover page promising co-authorship of the survey’s final paper if they filled in and returned the survey (an “academic incentive”), and

Results: For 429 surveyed surgeons, six-week response rates were similar for surgeons in the incentive – and no-incentive groups (36.8% vs. 35.4%, respectively, p=0.39). Similarly, response rates did not significantly differ between emailed and faxed surgeons (32.9% vs. 39.9%, respectively, p=0.13). The mean time to response seemed shorter in the incentive-group than in the no-incentive group (p=0.058).

Conclusion: We cannot recommend promising co-authorship to increase the response rates of surveys to orthopaedic surgeons. Additionally, emailed and faxed surveys yielded statistically similar response rates, leaving the decision regarding what modality to employ to time and money constraints.

Purpose: Radiographic healing is a common outcome measure in orthopaedic trials and adjudication by outcome assessors is often conducted using only plain radiographs. We explored the effect of adding clinical notes to radiographs in the adjudication process of a pilot trial of tibial shaft fractures.

Method: Radiographic and clinical data from a multicenter clinical trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. An independent adjudication committee of three blinded orthopaedic trauma surgeons evaluated radiographs for time to fracture healing. This committee then evaluated clinical notes associated with each radiographic follow up visit and were asked to either revise or maintain their initial impression. We calculated the proportion of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of the clinical notes and its relative influence on the committee’s decisions.

Results: Forty-seven of 51 patients were determined to have radiographic evidence of healing during the trial follow-up period, and consideration of the 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.

Conclusion: Addition of clinical notes changed the adjudication committee’s decision of radiographic fracture healing in a substantial number of cases. Our findings suggest that orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing.

Purpose: In recent years, there has been an increased appreciation of the importance of intimate partner violence (IPV), which is also known as domestic violence, spouse abuse, and battering, as a serious public health problem. Domestic violence is the most common cause of nonfatal injury to women in North America. As providers of musculoskeletal care and first-contact health care practitioners for many patients, orthopaedic surgeons should be knowledgeable regarding screening and possible interventions for IPV victims. The Canadian Orthopaedic Association and the American Academy of Orthopaedic Surgeons have both prepared explicit statements that orthopaedic surgeons should play a role in the screening and appropriate identification of victims of IPV. We aimed to identify the knowledge, attitudes, and beliefs about IPV among orthopaedic surgeons who are members of the Orthopaedic Trauma Association.

Method: We surveyed members of the Orthopaedic Trauma Association to identify attitudes toward IPV by posting a survey on the Orthopaedic Trauma Association website for its membership to complete. The survey consisted of three sections:

the general attitude of the orthopaedic surgeon toward intimate partner violence,

Results: One-hundred-and-fifty-three orthopaedic surgeons responded. The majority of the respondents were male (99%) with practices in North America (96%). Surgeons underestimated the prevalence of IPV in their practices and communities and manifested several key misconceptions:

victims must be getting something out of the abusive relationships (16%);

In the past year, approximately half of the surgeons (50.8%) acknowledged identification of a victim of IPV; however, only 4.0% of respondents currently screened for IPV among female patients with injuries. Surgeons expressed concerns about lack of knowledge in the management of abused women (30%) Guidelines for the detection and management of IPV were uncommon in most surgeons’ practices (7.8%).

Conclusion: There is a strong rationale for addressing IPV as an issue that is relevant to the field of orthopaedic surgery just as it has been shown to be relevant to primary care, emergency medicine, and obstetrics and gynecology. Our study found that orthopaedic surgeons underestimated the prevalence of IPV in their practices, held multiple misperceptions about IPV, and demonstrated discomfort in identifying and treating IPV. Targeted educational programs on IPV are needed for surgeons who routinely care for injured women.

Purpose: A lack of consensus regarding the radiologic criteria to diagnose spinal non-union limits inferences from clinical research. This systematic review aimed to examine the spectrum of radiologic investigations used to assess lumbar spinal fusion and the definitions of successful spine union used in the spine literature.

Method: We comprehensively searched three electronic databases from 1950 to 2009 (MEDLINE, Embase and the Cochrane Central Register of Controlled Trials) for clinical studies involving posterolateral fusion of the lumbar spine. English-language studies including adult patients and reporting a definition of successful fusion were included. Studies examining the reliability and validity of radiologic investigations were also identified. Key measures included

radiologic investigations,

Results: Among 1165 potentially eligible studies, 91 met our inclusion criteria. Of the studies 78% (n = 71) used plain radiographs to diagnose non-union, 4% (n = 4) used CT scans and 18% (n = 16) used both. Fifty-one studies used both static (xray or CT) and dynamic (flexion-extension xray) images, 35 used only static images and five used only dynamic radiographs. In total, we identified fifty-two different radiographic definitions of successful fusion. More than half of the studies (n = 50, 55%) failed to provide a reference for the definition used. The most common definition of fusion (7 studies) used static radiographs and defined fusion as continuous intertransverse bony bridging with this quality of fusion at all intended levels. Seven studies evaluated reliability of xray criteria but no studies provided complete validation of the definitions. Only 3 studies provided some validation and reliability estimates of thin-slice CT scanning in diagnosing spinal non-union. Significant variability in reliability, sensitivity and specificity exists for all radiologic investigations in the diagnosis of spinal non-union.

Conclusion: The radiologic investigations and definitions of successful posterolateral fusion used in the spine literature vary substantially. Choice of radiologic criteria should be based upon reliability and validity testing. Studies using fusion criteria that have not been shown to be reliable or valid should be interpreted with caution.

Purpose: Intimate partner violence (IPV), also known as domestic violence, is a pattern of coercive behaviors that include repeated physical, sexual and emotional abuse. Musculoskeletal injuries are common manifestations of IPV. We aimed to determine the proportion of women presenting to orthopaedic fracture clinics for treatment of orthopaedic injuries that have experienced IPV defined as physical, sexual, or emotional abuse within the past 12 months.

Method: We completed a cross-sectional study of 282 injured women attending two Level I trauma centres in Canada. Female patients presenting to the orthopaedic fracture clinics completed two validated self-reported written questionnaires (Woman Abuse Screening Tool (WAST) and the Partner Violence Screen (PVS)) to determine the prevalence of IPV. The questionnaire also contained questions that pertain to the participant’s demographic, fracture characteristics, and experiences with health care utilization.

Results: The overall prevalence of IPV (emotional, physical, and sexual abuse) within the last 12 months was 32% (95% Confidence Interval 26.4% to 37.2%) (89 of 282 women). One in 12 injured women disclosed a history of physical abuse (24/282, 8.5%) in the past year. Seven women (2.5%) indicated the cause for their current visit was directly related to physical abuse, of which five were fractures. We did not identify any significant trends in ethnicity, socioeconomic status, or injury patterns as markers of domestic abuse. Of 24 women with physical injuries, only four had been asked about IPV by a physician, none of whom were their treating orthopaedic surgeons.

Conclusion: Our study confirms a high prevalence of IPV among female patients with injuries attending orthopaedic surgical clinics in Ontario. Similar to previous research our study found that women of all ages, ethnicities, social economic status, and injury patterns may experience IPV. Surgeons should consider screening all injured women for domestic violence in their clinics.

Purpose: A significant proportion of spine fusion operations may result in a non-union. Electromagnetic stimulation is a non-invasive method used to promote spine fusion although the efficacy of its use in this regard remains uncertain. The purpose of this systematic review and meta-analysis is to evaluate the effect of electromagnetic stimulation on spine fusion.

Method: Five electronic databases (MEDLINE, Embase, CINAHL, PubMed and the Cochrane Central Register of Controlled Trials) were searched from database inception to July 2009 for randomized controlled trials of electrical stimulation and spinal fusion. In addition, we performed a hand search of four relevant journals from January 2000 to July 2009, the on-line proceedings of the North American Spine Society Annual Meeting from 2002 to 2008 and bibliographies of eligible trials. Trials randomizing adult patients undergoing any type of spine fusion to active treatment with direct current, capacitance coupled or pulsed electromagnetic field stimulation or placebo and reporting on fusion rates were included. Two independent reviewers extracted data regarding clinical outcomes, stimulation device, treatment regimen and methodologic quality.

Results: Of 1650 studies identified seven met the inclusion criteria. Electromagnetic stimulation in lumbar spine fusion was evaluated in five studies and two addressed cervical spine fusions. The use of electromagnetic stimulation in lumbar spine fusion resulted in a significant decrease in the risk of non-union (relative risk 0.60, 95% confidence interval 0.38 to 0.93, p = 0.02, I2 = 57%). The observed reduction in risk of nonunion with electromagnetic stimulation was not affected by smoking or the number of levels fused. Due to limited and conflicting trials, similar effects were not observed in the two studies evaluating cervical spine fusion rates (relative risk 0.85, 95% confidence interval 0.29 to 2.53, p = 0.77, I2 = 56%).

Conclusion: Pooled analysis shows a 40% reduction in the risk of non-union of lumbar spine fusions with the use of electromagnetic stimulation although a similar effect was not observed for fusions of the cervical spine. However, due to study heterogeneity the current indications for the use of electrical stimulation in spine fusion remain somewhat unclear.

Purpose: Today, numerous functional outcome tools exist to assess the patient’s ability to carry out basic and instrumental activities of daily living. Furthermore, the increase in range of mobility measures reflect differences in rating scales, scores, administration and scoring options which make outcome results difficult to assess across trials. Because of the lack of consensus among investigators, we wanted to identify the citation patterns of the functional outcomes tools used by investigators in hip fracture RCTs. We believed that the lack of proper citation is an underlying factor in the diverse usage of outcome tools.

Method: We extracted the citations of disability tools from 59 Level 1 hip fracture RCTs. Disability was defined using the WHO classification (ICF). We excluded measures assessing body structure. The text and reference lists of the identified articles were screened in order to compile relevant literature on the instrument used in the RCT. Disability tools which were cited in the references were also compared to original development articles.

Results: Overall 68 different instruments were identified that measured disability in the hip fracture literature. According to ICF, 47 tools measured body function alone, 13 tools evaluated activity limitations and participation restriction and 8 were composite scoring systems. We found that 34.2% of the trials did not provide any citations to the tools assessing body function. In trials measuring activity and participation, 23.2% provided instrument citations. In trials using composite scoring systems, 19.4% of the trials provided instrument citations. All of the instrument citations when provided by the investigators were found to correspond to original development articles or trials.

Conclusion: The appropriate choice of a functional outcome instrument is fundamental in order to ensure that the results that are obtained reflect the patient. However, if citations of the indices and scales themselves are lacking, trial methodology and results could be informative but not replicated. In the future, we recommend that rigor in quality reporting include proper instrument citations.

Purpose: Unbiased outcome assessment in orthopedic clinical trials has the potential to improve trial validity. The approaches used to limit bias in outcome assessment in orthopaedic trials remain unclear. The objective of this systematic review was to assess the reporting and process of outcomes assessment practices in the current orthopaedic trauma literature.

Method: We searched eight high-impact-factor medical and orthopaedic journals manually and using the MED-LINE electronic database for reports of randomized controlled trials published from 2005 to 2008 pertaining to the surgical treatment of trauma-related injuries. Two reviewers independently determined study eligibility and extracted relevant data from included trials.

Results: Of the 7910 citations identified during our search, 47 randomized controlled trials, which included a total of 4706 patients, met our inclusion criteria. Of 47 studies, 39 (83%) provided a statement to describe some process of outcome assessment and 29 (74%) reported using an unblinded individual as the outcome adjudicator. Four studies (10%) reported using a second assessor to verify outcome measurements, and three studies (8%) reported the use of an adjudication committee to reach endpoint decisions via consensus. No included study provided a rationale for the use of their chosen approach to adjudication. The most commonly adjudicated outcomes included fracture healing (15 studies), reoperation rate (6 studies), and general clinical assessment of post-operative complications and limb function (30 studies), mainly by orthopaedic surgeons. Blinding of outcome assessors was not performed or unclear in 38 studies (81%).

Conclusion: Despite the importance of the outcome assessment process in orthopedic trauma trials, key aspects of outcome assessment are insufficiently reported. This limits the ability of readers to assess the validity of published trials.

Purpose: Estimating recruitment for clinical trials is vital to ensuring the feasibility of larger multi-centre trials. We compared estimates of potential recruitment from a prospective eight-week screening study and a retrospective chart review across sites participating in three fracture management trials.

Method: During the planning phase of two multi-centre, randomized controlled trials regarding the operative treatment of hip (two studies) and tibial shaft (one study) fractures, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening all incoming patients for eligibility in the concerning trial, without actually enrolling any patient, for eight weeks. These prospective and retrospective estimates were correlated with each other (for 74 sites) and with actual one-year recruitment rates in the definitive trial (for nine sites).

Results: On average, a centre’s prospective estimate was only slightly lower than its retrospective estimate (3.1 patient-difference, p=0.64). Both predictions were substantial overestimations of recruitment in the definitive trial; only 31% (95% confidence interval: 28%–35%) of retrospectively estimated patients and 34% (95% confidence interval: 30%–37%) of prospectively estimated patients were recruited in the definitive trials (p< 0.001 and p=0.001 for both overestimations, respectively). The overall costs of conducting retrospective chart reviews and prospective screening studies in 65 sites were $68,107 ($CAN) and $153,725 ($CAN), respectively.

Conclusion: Compared to relatively simple and inexpensive chart reviews, prospectively screening for eligible patients at clinical sites did not result in more accurate predictions of accrual in large randomized controlled trials.

Purpose: The popularity of intramedullary nails (IMN) for trochanteric hip fractures has grown substantially with little supportive evidence that IMN are superior to conventional sliding hip screws (SHS). We aimed to assess the impact of SHS or IMN intramedullary nailing on functional outcomes and rates of re-operation in elderly patients with fractures.

Method: We conducted a multi-center, pilot randomized trial including three clinical sites across Sweden, Denmark, and Canada. We randomized 85 elderly patients with stable and unstable trochanteric hip fractures to either SHS or an IMN. The primary outcome, revision surgery, was independently adjudicated at one year. Secondary functional outcomes included the Parker Mobility Score (PMS), the Merle D’Aubigne Score, the Short Form-12 (SF-12) and the Euroquol-5D.

Results: Eighty five patients were enrolled. Fifteen patients died prior to the one year follow up. Across treatment groups, patients did not differ in age, gender and fracture type. The overall revision risk was 11.6% (8/69) and did not differ significantly between groups (IMN: 5; SHS: 3). Patients treated with IMN had significantly higher Merle D’Aubigne function subscores at 6 (p=0.01) and 12 months (p=0.05). Gamma3 nails approached significantly higher scores in the Parker mobility score at 6 (p=0.08) and 12 months (p=0.056). Non-significant differences were identified in the SF-12 and Euroquol-5D quality of life measures; however, in both scores, the Gamma3 nailed trended to higher scores than the sliding hip screw.

Conclusion: Our findings of early functional gains without increased risk of revision surgery support the increased popularity of IMN for the management of trochanteric hip fractures in elderly patients.

Purpose: Failure to adequately recruit patients in orthopaedic trials has often led to early stopping and publication of research findings from smaller sample sizes than originally planned. The purpose of this study is to demonstrate the effect of sample size in a large, clinical trial by using SPRINT trial data to evaluate the results that would have been reported if the trial were stopped at various enrollments.

Method: The SPRINT trial evaluated reamed vs. unreamed nailing in 1226 tibia fractures. We analyzed the re-operation rates after various increments in sample size and compared the early results that would have been reported at smaller enrollments with those seen in the final, adequately powered study.

Results: In the final analysis of 1226 patients, there was a significant reduction in the risk of re-operation with reamed nails for closed fractures (35% reduction; p=0.02) and a trend towards an increased risk of re-operation for open fractures (23% increase; p=0.26). In stark contradiction, the results for the first 50 patients enrolled in the trial revealed a substantial increased risk for reamed nails in closed fractures (risk increase: 165%). It was not until enrollment reached 800 patients that the results reflected the final findings of an advantage for reamed nails. In open fractures, the trend favoring unreamed nails was not seen until 200 patients had been enrolled.

Conclusion: Our findings suggest that stopping the SPRINT trial early would have led to misleading estimates of the treatment effect between reamed and unreamed nails.