We aimed to use data from a randomized controlled trial (RCT) comparing the sliding hip screw vs. intramedullary nailing (IMN) for trochanteric fractures to examine complication rates between those managed with a short vs. long IMN.

This is a secondary analysis using one arm of an RCT of patients ≥18 years with trochanteric fractures. We examined differences in fracture-related (femoral shaft fracture, implant failure, surgical site infection (SSI), nonunion, limb shortening, and pain) and medical (organ failure, respiratory distress, stroke, deep vein thrombosis [DVT] gastrointestinal upset, pneumonia, myocardial infarction, sepsis, or urinary tract infection) adverse events (AE), and readmission between short vs. long IMNs.

We included 412 trochanteric fracture patients, 339 (82.2%) of whom received a short (170mm–200mm) nail, while 73 (17.7%) received a long (260mm–460 mm) nail. Patients in the long group were more likely to be admitted from home (vs. an institution), and have comorbidities, or more complex fracture types.

Patients in the long group had higher rates of fracture-related AE (12.3%) vs. the short group (3.5%). Specifically, SSI (5.5% vs. 0.3%) and pain (2.7% vs. 0.0%) were significantly higher in the long group. Patients in the long group were also more likely to develop DVT (2.7% vs. 0.3%), and be readmitted to the hospital (28.8% vs. 20.7%).

Following covariable adjustment, long nails remained associated with a higher odds of fracture-related AE (5.11, 1.96–13.33) compared to short nails. We found no association between the adjusted odds of readmission and nail length (1.00, 0.52–1.94).

Our analyses revealed that trochanteric fracture patients managed with long IMN nails may have a higher odds of fracture-related AE compared to short nails. Future research is required to validate these findings with larger event rates, and further optimize IMN for trochanteric fracture patients.

Aims

Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA).

Aims

To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials.

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.

Aims

The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population.

Aims

To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures.

Artificial intelligence and machine-learning analytics have gained extensive popularity in recent years due to their clinically relevant applications. A wide range of proof-of-concept studies have demonstrated the ability of these analyses to personalize risk prediction, detect implant specifics from imaging, and monitor and assess patient movement and recovery. Though these applications are exciting and could potentially influence practice, it is imperative to understand when these analyses are indicated and where the data are derived from, prior to investing resources and confidence into the results and conclusions. In this article, we review the current benefits and potential limitations of machine-learning for the orthopaedic surgeon with a specific emphasis on data quality.

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.

Aims

Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery.

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.

International literature reports a 30% lifetime prevalence of intimate partner violence (IPV, domestic abuse). Many of those affected have little interaction with healthcare. Since a third of abused patients sustain musculoskeletal injuries, the fracture clinic has potential for identifying victims of abuse. The aim was to identify the proportion of fracture clinic patients who had suffered IPV within the past year.

A prospective questionnaire study of patients in three UK adult fracture clinics was conducted. There were no gender/age exclusions and the target sample size was 278. This study had ethics approval and the questionnaire used is validated in this population.

Of 336 respondents, 46% were females with 63% aged over 40 (212/336). The total prevalence of IPV within the preceding 12 months was 9% (29/336). The lifetime prevalence of IPV amongst respondents was 20% (68/336). 38% of patients suffering from IPV had been physically abused by their partner (11/29 vs. 7% in controls, p<0.001). None of the patients were being seen for an injury related to abuse. Two thirds of respondents thought that staff should ask routinely about IPV (64% 216/336) but only 5% had been asked about abuse (18/336).

This is the first study in the UK investigating prevalence of IPV in orthopaedics. There is a high lifetime prevalence of abuse in fracture clinic patients. Patients are willing to disclose abuse within the fracture clinic setting and are supportive of staff asking about abuse. This presents an opportunity to identify those at risk in this vulnerable population.

Aims

The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap versus normal saline) and irrigation pressure (very low versus low versus high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury levels at 12-months post-injury.

Objectives

The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF).

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.

Objectives

The diagnosis of surgical site infection following endoprosthetic reconstruction for bone tumours is frequently a subjective diagnosis. Large clinical trials use blinded Central Adjudication Committees (CACs) to minimise the variability and bias associated with assessing a clinical outcome. The aim of this study was to determine the level of inter-rater and intra-rater agreement in the diagnosis of surgical site infection in the context of a clinical trial.

Objectives

Despite the fact that research fraud and misconduct are under scrutiny in the field of orthopaedic research, little systematic work has been done to uncover and characterise the underlying reasons for academic retractions in this field. The purpose of this study was to determine the rate of retractions and identify the reasons for retracted publications in the orthopaedic literature.

Objectives

Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making.

Objectives

Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property.

Objectives

Current studies on the additional benefit of using computed tomography (CT) in order to evaluate the surgeons’ agreement on treatment plans for fracture are inconsistent. This inconsistency can be explained by a methodological phenomenon called ‘spectrum bias’, defined as the bias inherent when investigators choose a population lacking therapeutic uncertainty for evaluation. The aim of the study is to determine the influence of spectrum bias on the intra-observer agreement of treatment plans for fractures of the distal radius.

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: Bone Joint Res 2014;3:161–8.

Introduction

There has been a paradigm shift in orthopaedic research, it is now recognized that the extent to which interventions really make a difference to a patient's overall life is indicated by measuring one's general health status. The primary aim of this study was to report how the methodology of current evidence in hip fracture research can improve if studies included patients with cognitive impairment.

Purpose

We explored the role of patients beliefs and attitudes towards their likelihood of recovery from severe physical trauma.

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

Our hypothesis was that closed tibia fractures treated with intramedullary nails are impacted by surgeon and center volumes.

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.

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: 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: 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: 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: 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.