Functional outcomes are important for patients with bone tumors undergoing lower extremity endoprosthetic reconstruction; however, there is limited empirical evidence evaluating function longitudinally. The objective of this study was to determine the changes in function over time in patients undergoing endoprosthetic reconstructions of the proximal femur, distal femur and proximal tibia. We conducted a secondary analysis of functional outcome data from the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. Patient function was assessed with the Musculoskeletal Tumor Society Score 93 (MSTS) and the Toronto Extremity Salvage Score (TESS), which were administered preoperatively and at 3, 6 and 12 months postoperatively. Both instruments are scored from 0-100, with higher scores indicated greater function. Mean functional scores were evaluated over time and we explored for differences among patients undergoing proximal femur reconstructions (PFR), distal femur reconstructions (DFR) and proximal tibia reconstructions (PTR). The patient-importance of statistically significant differences in function was evaluated utilizing the minimally important difference (MID) of 12 for the MSTS and 11 for the TESS. We explored for differences in change scores between each time interval with paired t-tests. Differences based on endoprosthetic reconstruction undertaken were evaluated by analysis of variance and post-hoc comparisons using the Tukey test. A total of 573 patients were included. The overall mean MSTS and TESS scores were 77.1(SD±21) and 80.2(SD±20) respectively at 1-year post-surgery, demonstrating approximately a 20-point improvement from baseline for both instruments. When evaluating change scores over time by type of reconstruction, PFR patients experienced significant functional improvement during the 3-6 and 6-12 month follow-up intervals, DFR patients demonstrated significant improvements in function at each follow-up interval, and PTR patients reported a significant decrease in function from baseline to 3 months, and subsequent improvements during the 3-6 and 6-12 month intervals. On average, patients undergoing endoprosthetic reconstruction of the lower extremity experience important improvements in function from baseline within the first year. Patterns of functional recovery varied significantly based on type of reconstruction performed. The results of this study will inform both clinicians and patients about the expected rehabilitation course and functional outcomes following endoprosthetic reconstruction of the lower extremity.
Functional outcomes are commonly reported in studies of musculoskeletal oncology patients undergoing limb salvage surgery; however, interpretation requires knowledge of the smallest amount of improvement that is important to patients – the minimally important difference (MID). We established the MIDs for the Musculoskeletal Tumor Society Rating Scale (MSTS) and Toronto Extremity Salvage Score (TESS) in patients with bone tumors undergoing lower limb salvage surgery. This study was a secondary analysis of the recently completed PARITY (Prophylactic Antibiotic Regimens in Tumor Surgery) study. This data was used to calculate: (1) the anchor-based MIDs using an overall function scale and a receiver operating curve analysis, and (2) the distribution-based MIDs based on one-half of the standard deviation of the change scores from baseline to 12-month follow-up, for both the MSTS and TESS. There were 591 patients available for analysis. The Pearson correlation coefficients for the association between changes in MSTS and TESS scores and changes in the external anchor scores were 0.71 and 0.57, indicating “high” and “moderate” correlation. Anchor-based MIDs were 12 points and 11 points for the MSTS and TESS, respectively. Distribution-based calculations yielded MIDs of 16-17 points for the MSTS and 14 points for the TESS. The current study proposes MID scores for both the MSTS and TESS outcome measures based on 591 patients with bone tumors undergoing lower extremity endoprosthetic reconstruction. These thresholds will optimize interpretation of the magnitude of treatment effects, which will enable shared decision-making with patients in trading off desirable and undesirable outcomes of alternative management strategies. We recommend anchor-based MIDs as they are grounded in changes in functional status that are meaningful to patients.
Many studies report the incidence and prevalence of surgical site infections (SSIs) following open fractures; however, there is limited information on the treatment and subsequent outcomes of superficial SSIs in open fracture patients. There is also a lack of clinical studies describing the prognostic factors that are associated with failure of antibiotic treatment (non-operative) for superficial SSI. To address this gap, we used data from the FLOW (Fluid Lavage in Open Fracture Wounds) trial to determine how successful antibiotic treatment was for superficial SSIs and to identify prognostic factors that could be predictive of antibiotic treatment failure. This is a secondary analysis of the FLOW trial dataset. The FLOW trial included 2,445 operatively managed open fracture patients. FLOW participants who had a non-operatively managed superficial SSI diagnosed in the 12 months post-fracture were included in this analysis. Participants were grouped into two categories: 1) participants whose superficial SSI resolved with antibiotics alone and 2) participants whose SSI did not resolve with antibiotics alone (defined as requiring surgical management or SSI being unresolved at final follow-up (12-months post-fracture for the FLOW trial)). Antibiotic treatment success and the date when this occurred was defined by the treating surgeon. A logistic binary regression analysis was conducted to identify factors associated with superficial SSI antibiotic success. Based on biologic rationale and previous literature, a priori we identified 13 (corresponding to 14 levels) potential factors to be included in the regression model. Superficial SSIs were diagnosed in168 participants within 12 months of their fracture. Of these, 139 (82.7%) had their superficial SSI treated with antibiotics alone. The antibiotic treatment was successful in resolving the superficial SSI in 97 participants (69.8%) and unsuccessful in resolving the SSI in 42 participants (30.2%). We found that superficial SSIs that were diagnosed later in follow-up were associated with failure of treatment with antibiotic alone (Odds ratio 1.05 for every week in diagnosis delay, 95% Confidence Interval 1.004–1.099; p=0.03). Age, sex, fracture severity, fracture pattern, wound size, time from injury to initial surgical irrigation and debridement were not associated with antibiotic treatment failure. Our secondary analysis of prospectively collected FLOW data found antibiotics alone resolved superficial SSIs in 69.8% of patients diagnosed with superficial SSIs. We also found that superficial SSIs that were diagnosed earlier in follow-up were associated with successful treatment with antibiotics alone. This suggests that if superficial SSIs are diagnosed and treated promptly, there is a higher probability that they will resolve with antibiotic treatment.
Negative pressure wound therapy (NPWT) is commonly used to manage severe open fracture wounds. The recently completed X randomized controlled trial (RCT) evaluated the effect of NPWT versus standard wound management on 12-month disability and rate of deep infection among patients with severe open fractures of the lower limb and reported no differences. Using data from the Y trial of open fracture patients, we aimed to evaluate the impact of NPWT on the odds of having deep infections and health-related quality of life (HRQL). Our analyses included participants from the Y trial who had Gustilo II and III lower extremity fractures. To adjust for the influence of injury characteristics on type of dressing received, a propensity score was developed from the dataset. A one-to-one matching algorithm was then used to pair patients with a similar propensity for NPWT. Mixed effects logistic regression was used to evaluate the association between type of wound dressing and development of a deep infection requiring operative management (dependent variable) in the matched cohort. Gustilo type, irrigation solution, fracture location, mechanism of injury, and degree of contamination were included as adjustment variables. To determine any differences in HRQL between the NPWT and standard wound dressing groups, we conducted two multi-level models with three levels (centre, patient, and time) and included Short Form-12 (SF-12) Physical Health Component (PCS) and SF-12 Mental Health Component (MCS) as dependent variables. Gustilo type, irrigation solution, fracture location, mechanism of injury, degree of contamination, and pre-injury SF-12 scores were included as adjustment variables. All tests were 2-tailed with alpha=0.05. After applying propensity score-matching to adjust for the influence of injury characteristics on type of dressing used, there were 270 matched pairs of patients available for comparison. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.22 times higher in patients who received NPWT compared to those who did not receive NPWT (Odds Ratio (OR) 4.22, 95% Confidence Interval (CI) 2.26–7.87. 1,329 participants were included in our HRQL analysis and those treated with NPWT had significantly lower SF-12 PCS at all follow-up visits (6w, 3m, 6m, 12m) post fracture (p=0.01). Participants treated with NPWT had significantly lower SF-12 MCS at 6-weeks post-fracture (p=0.03). Unlike the X trial, our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management and that being treated with NPWT was associated with lower physical quality of life in the 12 months post-fracture. While there may have been other potential adjustment variables not controlled for in this analysis, our results suggest that the use of this treatment should be re-evaluated.
Distracted driving is now the number one cause of death among teenagers in the United States of America according to the National Highway Traffic Safety Administration. However, the risks and consequences of driving while distracted spans all ages, gender, and ethnicity. The Distractions on the Road: Injury eValuation in Surgery And FracturE Clinics (DRIVSAFE) Study aimed to examine the prevalence of distracted driving among patients attending hospital-based orthopaedic surgery fracture clinics. We further aimed to explore factors associated with distracted driving. In a large, multi-center prospective observational study, we recruited 1378 adult patients with injuries treated across four clinics (Hamilton, Ontario, Toronto, Ontario, Calgary, Alberta, Halifax, Nova Scotia) across Canada. Eligible patients included those who held a valid driver's license and were able to communicate and understand written english. Patients were administered questions about distracted driving. Data were analyzed with descriptive statistics. Patients average age was 45.8 years old (range 16 – 87), 54.3% male, and 44.6% female (1.1% not disclosed). Of 1361 patients, 1358 self-reported distracted driving (99.8%). Common sources of distractions included talking to passengers (98.7%), outer-vehicle distractions (95.5%), eating/drinking (90.4%), music listening/adjusting the radio (97.6%/93.8%), singing (83.2%), accepting phone calls (65.6%) and daydreaming (61.2%). Seventy-nine patients (6.3%), reported having been stopped by police for using a handheld device in the past. Among 113 drivers who disclosed the cause of their injury as a motor vehicle crash (MVC), 20 of them (17%) acknowledged being distracted at the time of the crash. Of the participants surveyed, 729 reported that during their lifetime they had been the driver in a MVC, with 226 (31.1%) acknowledging they were distracted at the time of the crash. Approximately, 1 in 6 participants in this study had a MVC where they reported to be distracted. Despite the overwhelming knowledge that distracted driving is dangerous and the recognition by participants that it can be dangerous, a staggering amount of drivers engage in distracted driving on a fairly routine basis. This study demonstrates an ongoing need for research and driver education to reduce distracted driving and its devastating consequences.
Brazilian jiu-jitsu (BJJ) is a grappling-based martial art which can lead to injuries both in training and in competitions. There is a paucity of data regarding injuries sustained while training in Brazilian jiu-jitsu both in competitive and non-competitive jiu-jitsu athletes. Our primary objective was to determine the prevalence of injuries sustained during jiu-jitsu training and competition. Our secondary objectives were to describe the types of injuries, and to determine which participant and injury characteristics are associated with desire to discontinue jiu-jitsu following injury, and characteristics are associated with requiring surgery for an injury. We conducted a survey of all BJJ participants at one club in Hamilton Ontario. We developed a questionnaire using focus groups, key informants and the previous literature. The questionnaire included questions on demographics, injuries in competition and/or training, treatment received, and whether the participant considered discontinuing BJJ following injury. The primary analysis was descriptive. The secondary analysis consisted of unadjusted logistic regression analyses to evaluate the association between selected demographic and injury patterns and those who considered quitting jiu-jitsu as a result of their injuries as a dependent variable. Seventy BJJ athletes participated in this study (response rate 85%). The majority of respondents were male (90%), over the age of 30 years (58.6%), and junior trainees (white belts [37.2%] or blue belts [42.9%]). Ninety one percent of participants were injured in training and 60% of competitive athletes were injured in competitions. Significantly more injuries were sustained overall (p < 0 .001) for each body region (p∼0.001) in training in comparison to competition. Two-thirds of injured participants required medical attention, with 15% requiring surgery. Participants requiring surgical treatment were six and a half times more likely to consider quitting compared to those requiring other treatments, including no treatment (OR: 6.50, 95% CI: 1.53–27.60). Participants required to take more than four months off training were five and a half times more likely to consider quitting compared to those who took less time off (OR: 5.48, 95% CI: 2.25–13.38). We identified that nine out of ten jiu-jitsu practitioners surveyed suffered injury while in training and the most severe injuries for the majority of practitioners occurring during training. The most common injuries identified involved the fingers, neck, knee, and shoulder, with the majority of respondents seeking medical or surgical treatment or requiring physiotherapy or rehabilitation. Potential participants in BJJ should be informed regarding significant risk of injury and instructed regarding appropriate precautions and safety protocols. BJJ practitioners and instructors should be especially cognizant of safety during training, where the majority of injuries occur.
Internal fixation is currently the standard of care for Garden I and II femoral neck fractures in the elderly. However, there may be a degree of posterior tilt on the preoperative lateral radiograph above which failure is likely, and primary arthroplasty would be preferred. The purpose of this study was to determine the association between posterior tilt and the risk of subsequent arthroplasty following internal fixation of Garden I and II femoral neck fractures in the elderly. This study represents a secondary analysis of data collected in the FAITH trial, an international multicenter randomized controlled trial comparing the sliding hip screw to cannulated screws in the management of femoral neck fractures in patients aged 50 years or older. For each patient who sustained a Garden I or II femoral neck fracture and had an adequate preoperative lateral radiograph, the amount of posterior tilt was categorized as < 2 0 degrees or ≥20 degrees. Multivariable Cox proportional hazards analysis was used to assess the association between posterior tilt and subsequent arthroplasty during the two-year follow-up period, while controlling for potential confounders. Of the 555 patients in the study sample, posterior tilt was classified as ≥20 degrees for 67 (12.1%) and < 2 0 degrees for 488 (87.9%). Overall, 13.2% (73/555) of patients underwent subsequent arthroplasty in the 24-month follow-up period. In the multivariable analysis, patients with posterior tilt ≥20 degrees had a significantly increased risk of subsequent arthroplasty compared to those with posterior tilt < 2 0 degrees (22.4% (15/67) vs 11.9% (58/488), Hazard Ratio (HR) 2.22, 95% confidence interval (CI) 1.24–4, p=0.008). The other factor associated with subsequent arthroplasty was age ≥80 (p=0.03). In this study of patients with Garden I and II femoral neck fractures, posterior tilt ≥20 degrees was associated with a significantly increased risk of subsequent arthroplasty. Primary arthroplasty should be considered for Garden I and II femoral neck fractures with posterior tilt ≥20 degrees, especially among older patients.
Despite long-standing dogma, a clear relationship between the timing of surgical irrigation and the development of subsequent deep infection has not been established in the literature. Traditionally, irrigation 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 multi-centre 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 irrigation (within six hours of injury versus beyond six hours) and subsequent reoperation rate for infection or healing complications within one year for patients with open extremity fractures requiring surgical treatment. To adjust for the influence of patient and injury characteristics on the timing of irrigation, a propensity score was developed from the data set. 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 (StataCorp LP, College Station, TX, USA). Two thousand, two hundred eighty-six of 2,447 patients randomized to the trial from 41 orthopaedic trauma centers across five countries had complete data regarding time to irrigation. Prior to matching, the patients managed with early irrigation had a higher proportion requiring reoperation for infection or healing complications (17% versus 12.8%, p=0.02), however this does not account for selection bias of more severe injuries preferentially being treated earlier. After the propensity score-matching algorithm was applied, there were 373 matched pairs of patients available for comparison. In the matched cohort, reoperation rates did not differ between early and late groups (16.1% vs 16.6%, p=0.84). When accounting for propensity matching in a logistic regression analysis, early irrigation was not associated with reoperation (OR 0.93, 95% CI 0.62 to 1.40, p=0.73). When accounting for other variables, late irrigation does not independently increase risk of reoperation.
Persistent post-surgical pain and associated disability are common after a traumatic fracture repair. Preliminary evidence suggests that patients' beliefs and perceptions may influence their prognosis. We sought to explore this association. We used data from the Fluid Lavage of Open Wounds trial to determine, in 1560 open fracture patients undergoing surgical repair, the association between Somatic PreOccupation and Coping (captured by the SPOC questionnaire) and recovery at 1 year. Of the 1218 open fracture patients with complete data available for analysis, 813 (66.7%) reported moderate to extreme pain at 1 yr. The addition of SPOC scores to an adjusted regression model to predict persistent pain improved the concordance statistic from 0.66 to 0.74, and found the greatest risk was associated with high SPOC scores [odds ratio: 5.63, 99% confidence interval (CI): 3.59–8.84, absolute risk increase 40.6%, 99% CI: 30.8%, 48.6%]. Thirty-eight per cent (484 of 1277) reported moderate to extreme pain interference at 1 yr. The addition of SPOC scores to an adjusted regression model to predict pain interference improved the concordance statistic from 0.66 to 0.75, and the greatest risk was associated with high SPOC scores (odds ratio: 6.06, 99% CI: 3.97–9.25, absolute risk increase: 18.3%, 95% CI: 11.7%, 26.7%). In our adjusted multivariable regression models, SPOC scores at 6 weeks post-surgery accounted for 10% of the variation in short form-12 physical component summary scores and 14% of short form-12 mental component summary scores at 1 yr. Amongst patients undergoing surgical repair of open extremity fractures, high SPOC questionnaire scores at 6 weeks post-surgery were predictive of persistent pain, reduced quality of life, and pain interference at 1 yr.
Shoulder impingement is one of the most common non-traumatic upper limb causes of disability in adults. Often resulting in pain and disability, management remains highly debated. This meta-analysis of randomized trials aims to evaluate the efficacy of surgical intervention in the setting of shoulder impingement in comparison to non-operative or sham treatments. Two reviewers independently screened MEDLINE, EMBASE, PUBMED and Cochrane databases for randomized control trials published from 1946 through to May 19th, 2018. A risk of bias assessment was conducted for all included studies and outcomes were pooled using a random effects model. The primary outcome was improvement in pain up to two years. Secondary outcomes included functional outcome scores reported at the short term (/=2 years). Heterogeneity was assessed using the I2statistic. Functional outcome scores were presented along with minimal clinically important differences to provide clinical context to findings. Twelve RCT's (n=1062 patients) were included in this review. Eligible patients were a mean age of 48 (SD +/− 4) years with 45% being male gender. The pooled treatment effect of surgical intervention for shoulder impingement did not demonstrate any benefit to surgery with respect to pain relief (mean difference [MD] −0.07, 95% CI −0.40 to 0.26) or short-term functional outcomes (standardized mean difference [SMD] −0.09, 95% confidence interval [CI] −0.27 to 0.08). Surgical intervention did result in a small statistically significant but clinically unimportant improvement in long term functional outcomes (SMD 0.23, 95% CI 0.06 to 0.41). Evidence suggests surgical intervention has little, if any, benefit for impingement pathology in the middle-aged patient.
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.
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:
Our hypothesis was that closed tibia fractures treated with intramedullary nails are impacted by surgeon and center volumes. Data from 813 patients with closed tibia fractures were obtained from the SPRINT study. Using multiple regression, we examined the effect of center and surgeon volume (categorized as high, moderate, or low), and geographic differences by country (Canada, USA, and the Netherlands) on health-related quality-of-life and revision surgeries to gain union at one year. Our measures of quality-of-life were the Short-Form 36 Health Survey Questionnaire (SF-36 PCS) and the Short Musculoskeletal Function Assessment (SMFA).Purpose
Method
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
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. We reviewed the proceedings of the 2009 Annual American Association of Hip and Knee Surgeons (AAHKS) and Orthopaedic Trauma Association (OTA). Information including the number of studies, self-reported conflicts, nature of conflicts, and direction of study results were extracted. Conflicts were compared between arthroplasty and trauma meetings.Purpose
Method
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. A systematic search of MEDLINE, EMBASE, and COCHRANE databases was conducted from inception to May 2010 for all trials involving the use of cross-linked polyethylene for total hip arthroplasty. Eligibility for inclusion in the review was: use of a random allocation of treatments; a treatment arm receiving cross-linked polyethylene and a treatment arm receiving conventional polyethylene for total hip arthroplasty; and use of radiographic wear as an outcome measure. Eligible studies were obtained and read in full by two co-authors who then independently applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to each study. Pooled mean differences were calculated for the following continuous outcomes: bedding-in, linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear. Pooled risk ratios were calculated for radiographic osteolysis and revision hip arthroplasty.Purpose
Method
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. A literature search was performed by a library sciences professional. Two authors excluded papers not relevant to the study in two stages with clearly outlined criteria and adjudication. Inter-observer agreement was measured with the kappa statistic. Data extraction was performed by the same two authors with measure of agreement and adjudication from a third author. Data extraction included: incidence of malrotation, method used for measurement of malrotation and use of intraoperative techniques to minimize malrotation.Purpose
Method
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. Participants completed the Health Utility Index 3 (HUI) questionnaire at two weeks after hospital discharge, and three, six, and 12 months post-surgery. We calculated quality adjusted life years (QALYs) for each patient for the first 12 months following intramedullary nailing. A convenience sample of 235 SPRINT patients with similar baseline characteristics provided data on healthcare resource utilization. Costs associated with the healthcare resource utilization were obtained from the 2008 Physicians Schedule of Benefits and a Case Costing System.Purpose
Method
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. Forty orthopaedic residents attended a research course provided by the main author in preparation for this assessment. Immediately after formal teaching, these residents were administered a survey that assessed residents perceived and actual level of understanding of basic modes of presenting results including number needed to treat (NNT), relative risk (RR), odds ratio (OR), and absolute risk reduction (ARR). Residents were given a multiple choice clinical case scenario of fracture nonunion and asked to choose which result would be most efficacious at reducing nonunion. An All are equally efficacious option was given for each question. The multiple choice answers were purposefully identical with regard to effect size but answers differed in the way they were presented.Purpose
Method
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.Purpose
Method
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.