Purpose: To determine the effect of reamed versus non-reamed intramedullary (IM) nailing of femoral diaphyseal fractures on the rates of non-union and acute respiratory distress syndrome (ARDS).

Method: We searched the online databases of OVID, MEDLINE, EMBASE, PubMed, and the Cochrane collaboration for randomized clinical trials (RCT) from 1998 to 2009. Additional studies were identified by hand searches of major orthopaedic journals, reference lists of eligible studies, SCISEARCH, and title reviews of presentations from major orthopaedic trauma meetings. Inclusion criteria were trials evaluating the effect of reamed versus nonreamed closed interlocked intra-medullary nailing of femoral diaphyseal fractures on the rates of nonunion or acute respiratory distress syndrome (ARDS) in skeletally mature adults. Exclusion criteria included patients with pathologic fractures, skeletally immature patients, as well as observational and other non-randomized studies.

Results: Seventy-two citations were initially identified out of 1,147 studies. 6 studies matched all eligibility criteria as assessed by three independent reviewers. A total of 941 patients with 956 femoral diaphyseal fractures treated with intramedullary nailing met the eligibility criteria. The relative risk of non-union (four trials, n= 456 patients) was 0.29 [95% confidence interval (CI), 0.14 to 0.57; p< 0.00001] (ie. a 70% relative risk reduction of nonunion) in favour of a reamed intramedullary nail There was no significant difference in the rates of ARDS following reamed or non-reamed nailing, relative risk for ARDS (two trials, n=397) 1.10 [95% CI, 0.27 to 4.54, p=0.18].

Conclusion: The study suggests that reamed intramedullary nailing of femoral diaphyseal fractures significantly reduces the risk of non-union as compared to nonreaming. The risk of ARDS was not statistically significant between groups; however there was a slight trend towards ARDS iwith reamed IM fixation.

Purpose: Identification of novel therapeutics to accelerate acute fracture healing remains critical. A prostaglandin EP-2 receptor agonist (CP-533,536) has demonstrated acceleration of fracture healing in preclinical models.

Method: In a phase II randomized, blinded, placebo-controlled trial the efficacy of a single local injection of three doses of CP-533,536 (0.5mg, 1.5mg and 15mg) was compared to both placebo and a standard of care arm in patients with closed tibial shaft fractures treated with reamed inter-locked intramedullary nails. Patients were followed at two week intervals to six months with a final evaluation at one year. Fracture healing was independently adjudicated by a radiologist panel and an orthopedic surgeon panel.

Results: Ninety-nine patients were enrolled ranging in age from 17–76 years. Baseline characteristics were comparable across treatment groups. No statistically significant differences in median healing time between any of the CP-533,536 treatment groups and placebo were observed based on radiology panel assessment, however significant differences were demonstrated by an orthopedic panel. At weeks eight, 10, 12, 14 and 16 a higher percentage of subjects in the CP-533,536 1.5 and 0.5 mg groups were considered healed compared to the placebo and the 15 mg groups by the orthopedic panel assessment. Moreover, the CP-533,536 – 0.5 mg group showed a statistically higher (p≤0.05) mean radiographic healing score than placebo treated group at weeks eight, 14, 16, 18, and 24.

Conclusion: CP-533,536 demonstrated accelerated healing in patients with acute tibia fractures by an orthopedic panel. Confirmatory trials are required to assure validity of the observed treatment effects.

Purpose: To compare the functional outcome and quality-of-life following a displaced extra-articular proximal humerus fracture treated with open reduction and locking plate fixation versus non-operative management. To provide preliminary data for a subsequent prospective clinical trial.

Method: Eligible subjects were identified through retrospective searches of a large emergency department admission database and the orthopaedic trauma database. All subjects ages ³ 55 treated for a proximal humerus fracture between 2002 to 2005 were invited to participate. The Disabilities of Arm, Shoulder, and Hand (DASH), Health Utilities Index Mark 3 (HUI), Euroqol-5D (EQ-5D), and the SF-36 questionnaires were mailed to all eligible subjects. Initial radiographs were reviewed using the AO/OTA classification system. Only patients with A3, B1, B2, or B3 fractures were included.

Results: Thiry-four subjects were included: 15 were treated with sling immobilization and 19 with locked plate ORIF. The non-operative group was approximately seven years older (mean age 74 versus 67, p = 0.046). DASH scores were similar between the groups: ORIF 26.6 ± 24 and Sling 26.5 ± 20. The 95% CI surrounding the 0.01 point difference (−16.0 to 15.9) slightly exceeds the 13 point cutoff for the instrument’s measurement error (minimal detectable change). Using univariable analysis, no statistically significant differences in health state values were detected. The mean HUI value for the ORIF group was 0.68 versus 0.75 for the sling (p=0.48). Mean EQ-5D values were 0.77 for the ORIF group and 0.80 for the sling group (p=0.73). The SF-36 PCS scores were also similar between the two groups: ORIF 41.1 versus Sling 39.8 (p=0.77). When controlling for age and pre-injury function, a 0.09 point difference in HUI values was detected favouring the sling treatment (p=0.036). No differences in DASH, EQ-5D, or SF-36 PCS scores were detected using regression models.

Conclusion: The results of this small cohort suggest, for extra-articular fractures, the functional and quality of life outcomes may be similar between the two interventions. No trial comparing locked plate fixation and non-operative management has been reported. A total of 96 subjects will be needed for a prospective clinical trial comparing the two treatments (DASH difference 15, 80% power, 0.05 two-sided alpha).

Purpose: To examine patterns of physical injury associated with intimate partner violence (IPV) among women presenting to emergency room departments.

Method: Systematic searches of Medline, EMBASE, and CINAHL electronic databases from their earliest entries up to February 2008. Reference lists from the studies included from the electronic database search were reviewed for published and unpublished studies. We contacted study authors regarding published and unpublished information. After titles and abstracts were initially screened by a single reviewer, two reviewers screened the remaining full-text articles for inclusion into the review. Studies were included if they pertained in whole or in part to women who presented to an emergency department because of IPV and reported the location or type of injuries. Studies without comparison groups of non-IPV women and case series/case reports were excluded. We performed a meta-analysis of the available data using the random effects model.

Results: We identified 262 potentially relevant titles and abstracts, of which 7 articles were included in the review. The association between head, neck, or facial injuries and IPV was higher among studies that excluded women with verifiable injuries such as witnessed falls or motor vehicle collisions (pooled odds ratio 24 (95%CI: 15 Ã^-¿½ 38)). Thoracic, abdominal, or pelvic injuries were non-specific for IPV (pooled odds ratio 1.07 (95% CI: 0.89 Ã^-¿½ 1.29)). Injuries in the upper extremities were suggestive of non-IPV etiology (pooled odds ratio 0.51 (95%CI: 0.41 Ã^-¿½ 0.54)), as were lower extremity injuries (pooled odds ratio 0.15 (95%CI: 0.04 Ã^-¿½ 0.56)).

Conclusion: Among women presenting to emergency room departments, unwitnessed head, neck, or facial injuries are significant markers for intimate partner violence. Conversely extremity injuries are less likely to have been the consequence of IPV.

Purpose: Hip fractures are associated with a high rate of mortality and profound temporary and sometimes permanent impairment of independence and quality of life. While guidelines exist for the surgical treatment of hip fracture patients, the effect of surgical delay on mortality and other patient-important outcomes remains unclear. The objective of this systematic review and meta-analysis was to determine the effect of early surgery compared with delayed surgery on the risk of mortality, common postoperative complications, and length of hospital stay among elderly hip fracture patients.

Method: We searched MEDLINE and EMBASE for relevant prospective studies evaluating surgical delay in patients undergoing surgery for hip fractures published in all languages between 1966 and 2008. We identified additional studies through contacting experts, as well as hand searches of the bibliographies of relevant articles and the archives of orthopaedic annual meetings. Two reviewers independently assessed methodological quality and extracted relevant data. When necessary, we contacted authors for clarification of study design or to provide additional data. Data were pooled by use of a DerSimonian and Laird random-effects model based on the inverse variance method.

Results: Of 1917 citations identified, 16 observational studies, which included a total of 13,565 patients with complete mortality data, met our inclusion criteria. Irrespective of the cut-off for delay (24, 48, or 72 hours), earlier surgery (< 24, < 48, or < 72 hours) was significantly associated with a reduction in the risk of unadjusted one-year mortality (relative risk 0.55; 95% confidence interval, 0.40 to 0.75, p=0.0002) and adjusted mortality rates (relative risk 0.81; 95% confidence interval, 0.68 to 0.96, p=0.01). Earlier surgery also reduced in-hospital pneumonia (relative risk 0.59; 95% confidence interval, 0.37 to 0.93, p=0.02), pressure sores (relative risk 0.48; 95% confidence interval, 0.34 to 0.69, p< 0.0001) and hospital stay (weighted mean difference 9.95 days; 95% confidence interval, 1.52 to 18.39, p=0.02).

Conclusion: Earlier surgery reduced the risk of mortality, postoperative pneumonia, pressure sores, and length of hospital stay among elderly hip fracture patients suggesting that it may be warranted to reduce administrative delays whenever possible. However, potential residual confounding of observational studies may limit any definitive conclusions.

Purpose: Identifying optimal treatment strategies in patients with traumatic foot and ankle injuries has been hampered by the variety of different measurement tools and lack of validation of generic and foot-specific functional measures. It remains plausible that the choice of functional outcome measure may influence our ability to accurately measure treatment effects. This prospective observational study aims to correlate the scores across six functional outcome measures in patients with traumatic foot and ankle injuries and to examine agreement of scores and patients’ subjective health status.

Method: Patients with traumatic foot or ankle injuries completed two generic, the SF-12 Health Survey and the Short Musculoskeletal Functional Assessment (SMFA), and four specific health outcome measures, the Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM), American Academy of Orthopedic Surgeons (AAOS) Foot and Ankle Questionnaire and the American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale, at a single follow-up visit. Raw scores were calculated and used to assign patients to a categorical functional level (excellent, very good, good, fair or poor). Agreement between the assignments was assessed and Pearson correlation co-efficients were calculated for each pair of outcome scores. Statistical significance was determined using an α of 0.05.

Results: 52 patients (mean age 43.3 ± 16.8 years) were enrolled at a mean follow-up of 15.5 months. All correlations except for that between the AOFAS ankle-hindfoot scale and the mental component of the SF-12 were statistically significant. The strongest correlations were found between the SMFA, FFI, AAOS Foot and Ankle Questionnaire and the FAAM. Despite significant correlation between scores and patients’ subjective functional outcome, there was minimal agreement between assigned categorical functional levels.

Conclusion: The high correlations between scores on the generic and foot-specific functional measures suggest that it is likely unnecessary to use more than one instrument when examining functional outcome in patients with traumatic foot and ankle injuries. Generic tools also appear to function as well as specific scores in this population. However, assignment of patients to a categorical functional level based on raw outcome scores must be performed with caution as the results obtained may not accurately reflect functional outcome.

We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene.

The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I² = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery.

Background: Traditionally, non-displaced scaphoid fractures are considered by most as stable with predictable rates of healing with conservative treatment. There is a current trend in orthopedic practice, however, to treat non- or minimal displaced fractures with early open reduction and internal fixation. This trend is not evidence based. In this systematic review and meta-analysis, we pool data from trials comparing surgical and conservative treatment for acute scaphoid fractures, thus aiming to summarize the best available evidence.

Methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and reference list of articles, and contacted researchers in the field. We selected eight randomized controlled trials comparing surgical versus conservative interventions for acute scaphoid fractures in adults. Data were pooled using fixed-effects and randomeffects models with standard mean differences (SMD) and risk ratios for continuous and dichotomous variables respectively. Heterogeneity across studies was assessed with Forest plots and calculation of the I2 statistic.

Results: Four-hundred seventeen patients were included in eight trials (205 fractures were treated surgically and 212 conservatively). Most trials lacked scientific rigor. Four studies assessed functional outcome with validated physician- and patient-based outcome instruments. With the numbers available (200 patients), we found a significant difference according to our primary outcome measure, standardized patient-based outcome in favor of surgical treatment (p< 0.0001). With regard to our secondary parameters, we found heterogeneous results that favored surgical treatment for grip strength, time to union and time off work. In contrast we found no significant differences between surgical and conservative treatment for pain, range of motion, rate of nonunion, malunion, and infection, rate of complications, and total treatment costs.

Conclusions: Patient-rated functional outcome and satisfaction as well as time to return to function favored surgical treatment for acute scaphoid fractures. However, there is no evidence from prospective randomized controlled trials on physician-rated functional outcome, radiographic outcome, complication rates and treatment costs to favor surgical or conservative treatment for acute scaphoid fractures.

Background: There is no consensus on the surgical management of unstable distal radius fractures. In this systematic review and meta-analysis, we pool data from trials comparing external fixation and internal fixation for treatment of this injury.

Methods: We searched electronic databases and conference proceedings for published and unpublished trials. Two authors independently screened titles and s, reviewed manuscripts, graded methodological quality, and extracted all relevant information from eligible studies. Data were pooled using fixed-effects and random-effects models with standard mean differences (SMD) and risk ratios for continuous and dichotomous variables, respectively. Heterogeneity across studies was assessed with Forest plots and calculation of the I2 statistic. Subgroup analyses were defined a priori and performed where appropriate.

Results: We pooled data from nine comparative trials, totaling 750 patients (360 fractures treated with external fixation and 397 with internal fixation). Initially, we found substantial heterogeneity between studies and no significant difference according to our primary outcome measure, validated patient-reported outcomes (SMD=0.20, 95% confidence interval=[−0.12, 0.51], p=0.22, I2=65%). However, when we grouped studies by plate type, we eliminated heterogeneity within each subgroup and found locking volar plates demonstrated significantly better patient-reported outcomes compared to external fixation (SMD=1.30, 95% CI=[0.74, 1.86], p< 0.00001, I2=0%). Additionally, we found internal fixation yielded significantly better recovery of forearm supination and restoration of volar tilt (SMD=0.31, 95% CI=[0.15, 0.47], p=0.0002, I2=0; SMD=0.57, 95% CI=[0.57, 0.78], p< 0.00001, I2=0, respectively). Subgroup analyses showed external fixation yielded better wrist flexion among randomized studies (SMD= 0.43, p< 0.003, 95% CI=[ 0.67, 0.20], I2=0), and there was no significant difference in grip strength among studies with high methodological quality (SMD= 0.08, 95% CI=[−0.34, 0.18], p=0.54, I2=0%).

Conclusions: Open reduction and internal fixation of unstable distal radius fractures yields greater recovery of forearm supination, better restoration of anatomic volar tilt, and, for locking volar plates in particular, superior patient-reported function. External fixation may result in better wrist flexion, but no difference exists in terms of grip strength.

Background: One of the disadvantages of the Impact Factor (IF) is self-citation. The SCImago Journal Rank (SJR) indicator excludes self-citations and incorporates quality of citations that a journal receives by other journals, rather than absolute numbers. This study re-evaluated self-citation influence on the 2007 IF for 17 major orthopaedic journals and the difference in ranking using IF or SJR was investigated.

Methods: Divided in a general (n = 8) and specialized (n = 9) group, all journals were analysed for self-citation rate, self-cited rate and citation density. Rankings of the 17 journals for IF and SJR were determined and the difference in ranking was calculated.

Results: Specialized journals had higher self-citation rates (p = 0.05), self-cited rates (p = 0.003) and lower citation-densities (p = 0.01). Both groups correlated for self-citation rate and impact factor (general: r = 0.85 ; p = 0.008) (specialized: r = 0.71 ; p = 0.049).

When ranked for SJR instead of IF, five journals maintained rank, six improved their rank and six experienced a decline in rank. Biggest differences were seen for BMC MD (+7 places) and CORR (− 4 places). Group-analyses for the IF (general: 7.50 – 95%CI 3.19 to 11.81) (specialized: 10.33 – 95%CI 6.61 to 14.06) (p = 0.26), SJR (general: 6.63 – 95%CI 2.66 to 10.60) (specialized: 11.11 – 95%CI 7.62 to 14.60) (p = 0.07) and the difference between both rankings (general: 0.88 – 95%CI –1.75 to 3.50) (specialized: − 0.78 – 95%CI –2.20 to 0.65) (p = 0.20), showed an enhanced underestimation of sub-specialist journals.

Conclusion: Citation analysis shows that general journals tend to use more citations per published article and a larger portion of self-citations constitutes citations of sub-specialist journals compared to more general journals. The SJR excludes the influence of self-citation and awarded prestige by the SJR implies a different quality-evaluation for most orthopaedic journals. A disadvantage using this indicator, is an enhanced effect of underestimation of sub-specialist journals.

Background: Hip fracture trials have employed a wide range of patient-reported outcomes (PRO) suggesting a lack of consensus among clinicians on what are considered the most relevant outcomes. Variability in functional outcome reporting in hip fracture management creates challenges in the comparison of results across trials. The purpose of this study was to conduct a systematic review of the functional outcomes fielded in randomized controlled trials in post-operative hip fracture treatment for the aged. We hypothesized that over time there had been an increase in patient-reported outcomes along with aggregate scoring systems of hip function.

Methods: An electronic database search was conducted using key terms combining: ‘hip fracture’ with ‘RCT’ with ‘age 65 years and over’. s and titles were screened in duplicate and independently. All of the articles that met eligibility criteria were reviewed using the 21-point Detsky Quality Assessment Scale.

Results: In 2451 citations, 86 studies were included and also met accepted standards of inter-observer reliability (kappa, 0.92; 95% confidence interval, 0.87 to 0.98). The mean score (and standard error) for the quality of the randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3%–79.3%) and 27 (32.6%) of the trials scored < 75%. Medical trials had a higher mean quality score than did surgical trials (83.7% compared with 72.7 %, p = 0.025). 59 trials (30 Surgical, 11 medical and 18 rehabilitation trials) scored > 75% in quality. Out of 86 trials, 8 (13.6%) used EQ-5D for utility and 6 (10.1%) used the SF-36 health status measures. At most, 12 trials used the same composite score: 12 (13.9%) ADL Katz Index, 9 (10.4%) trials used the HHS and 8 (9.3%) trials used Parker’s mobility score.

Conclusion: Although in the past decade more studies have made use of outcome instruments that capture both impairment and functional status in one aggregate score, there is a lack of standardized assessment.

Purpose: Domestic violence is the most common cause of nonfatal injury to women in North America and musculoskeletal injuries were the second most common manifestation of intimate partner violence (IPV). We aimed to identify the perceptions, attitudes, and knowledge about IPV among orthopaedic surgeons.

Method: Using a systematic random sample, we mailed surveys to 362 members of the Canadian Orthopaedic Association to identify attitudes towards IPV. The questionnaire consisted of three sections:

General Attitude of Orthopaedic Surgeon Towards IPV,

Up to 3 follow up mailings were performed to enhance response rates.

Results: Respondents (N = 186, response rate: 51%) consisted of 167 (91%) male orthopaedic surgeons, all actively practicing at the time of the survey. Most orthopaedic surgeons (95%) estimated that victims of IPV comprised less than 10% of their patients, the majority of whom (80%) believed it was exceedingly rare.

Conclusion: Orthopaedic surgeons grossly underestimated the prevalence of IPV in their communities. Discomfort with the issue and lack of knowledge led to misconceptions about IPV. The relevance of IPV to surgical practice was well supported but prevalence studies are needed change the current paradigm in orthopaedics.

Background: The literature on hip fractures is increasingly reporting patient-reported outcomes along with aggregate scoring systems. However, this rapid growth in the number and types of patient-based outcomes can be confusing. The purpose of this paper is to conduct a systematic review of the functional outcome instruments fielded in high quality randomized clinical trials evaluating postoperative hip fracture management and rehabilitation in the aged.

Methods: An electronic database search was conducted using a variety of key terms combining: ‘hip fracture’ with ‘RCT’ with ‘age 65 years and over’. Abstracts and titles were screened in duplicate and independently. Studies were eligible based on the following criteria: hip fracture, randomized controlled trial, mean age of 65 years, and in the English language. Studies were excluded based on the following criteria: inclusion of fractures other than hip, minimum age of patient enrolment < 50 years old and prevention or fracture risk reduction as primary outcome of study. All of the articles that met eligibility criteria were reviewed using the Detsky Quality Assessment Scale.

Results: In 2451 citations, 86 studies were included and also met accepted standards of inter-observer reliability (kappa, 0.92; 95% confidence interval, 0.87 to 0.98). Discordance was resolved by consensus. The mean score (and standard error) for the quality of the randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3%–79.3%) and 27 (32.6%) of the trials scored < 75%. Medical trials had a higher mean quality score than did surgical trials (83.7% compared with 72.7 %, p = 0.025). Data was abstracted from the 59 trials (30 Surgical, 11 medical and 18 rehabilitation trials) scoring > 75% in quality. Surgical trials had 16.7% more measures of disability than measures of impairment. Furthermore, 70% of the surgical trials used composite scores when compared to either medical or rehabilitation trials. Eight trials (13.6%) used EQ-5D for utility and 6 (10.1%) used the SF-36 health status measures. At most, 10 trials used the same composite score: 10 (16,9%) ADL Katz Index, 9 (15.2%) trials used the Harris hip score and 5 (8.5%) trials used Parker’s mobility score.

Discussion/Conclusion: Although there is a trend towards studies assessing functional recovery as a primary outcome in the aged with hip fractures, none of the measures were used consistently. A lack of standardized assessment in these groups of patients will overestimate treatment effects.

Purpose: The choice of irrigating fluid and delivery pressure remains controversial. Identifying surgeons’ preferences in techniques and the rationale for their choices may aid in focusing educational activities to the orthopaedic community as well as planning future clinical trials. Our objective was to clarify current opinion with regard to the irrigation of open fracture wounds.

Method: We mailed and delivered a cross-sectional survey using a sample-to-redundancy strategy to members of the Canadian Orthopaedic Association and attendees of an international fracture course (AO, Davos, Switzerland) to examine surgeons’ preferences in the initial management of open fracture wounds.

Results: Of the 1,764 surgeons who received the questionnaire, 984 (55.8%) responded. In the management of open wounds, most surgeons surveyed, 676 (70.5%), favoured normal saline alone, however 16.8% used Bacitracin. Many surgeons, 695 (71%) used low pressures when delivering the irrigating solution to the wound, however variation exists in what constituted high versus low pressure lavage. Surgeons supported the need for a clinical trial evaluating outcomes following both the use of different irrigating solutions as well as irrigating pressures [803 (84.8%) and 730 (77.6%) respectively].

Conclusion: The majority of surgeons favour both normal saline and low pressure lavage for the initial management of open fracture wounds.

Purpose: The CLEAR NPT checklist provides guidelines for the reporting of non-pharmacological randomized controlled trials (RCTs). We aimed to

apply the CLEAR NPT to orthopaedic RCTs and

Methods: We searched for orthopaedic RCTs across eight journals in the period from January 2004 through December 2005. We applied the CLEAR NPT to all eligible studies, and then contacted authors to determine what methodological safeguards were actually used.

Results: We included eighty-seven RCTs from eighty-five scientific reports. In assessing the RCTs with the CLEAR NPT, seventy-three (84%) studies had unclear reporting of allocation concealment. Only seventeen (20%) studies made mention of operator skill or experience. Participant, ward staff, rehabilitation staff, clinical outcome assessor and non-clinical outcome assessor blinding were found to be unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%) and thirty-three (38%) studies respectively. Authors from forty-three RCTs responded to our survey. In direct contact, authors reported adequate allocation concealment 41% (95% CI = 25–58%) of the time when this was unclear from the RCT report. 70% of authors acknowledged that they had set objective measures such as minimum case criteria and/or comparison to good clinical outcomes. Authors specified that they had blinded relevant groups 28–40% of the time, despite unclear reporting in the publications.

Conclusions: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias reducing safeguards not reported in an RCT did not occur.

Winner of ISFR Best Paper Award

Introduction: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. We assessed the impact of reamed versus unreamed intramedullary nailing on re-operation rates.

Methods: The Study to Prospectively Evaluate Reamed Intamedullary Nails in Tibial Fractures (SPRINT) was a multi-center, randomized trial including 29 clinical sites. 1339 patients with tibial shaft fractures were randomized to either reamed or unreamed intramedullary nail insertion. Re-operations before 6 months were not permitted unless there was critical bone loss. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures.

Results: Of 1339 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender, and fracture types. The overall event rate was 17.8% (13.7% closed, 27%, open fractures). In 826 patients with closed fractures, patients with a reamed nail had a relative risk reduction of 33% (95%CI: 4–53%, P=0.03). This treatment effect was largely driven by differential autodynamization rates (rel risk: 0.42, p=0.01). Among 400 patients with open fractures, there was a trend towards an increased risk of an event (rel. risk=1.27, p=0.16) for those who received a reamed nail.

Conclusions: Our overall incidence of revision surgery was lower than reported in previous studies. Optimizing peri-operative care and avoiding premature re-operation may substantially decrease the need for re-operation in tibial fracture patients.

Purpose: Surgeons agree on the benefits of intramedullary nailing of tibial shaft fractures. The SPRINT primary objective aimed to assess the impact of reamed versus unreamed intramedullary nailing on rates of re-operation in patients with tibial shaft fractures.

Method: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Fractures (SPRINT) was a multi-centre, randomized trial including 29 clinical sites. SPRINT enrolled 1319 patients with open or closed tibial shaft fractures. Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were not permitted unless there was critical bone loss. Patients received a statically locked intramedullary nail with either reamed or unreamed insertion. The primary outcome was re-operation to promote healing, treat infection, or preserve the limb. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. Our sample size calculations required 1200 patients followed for 1 year.

Results: Of 1319 enrolled patients, 1226 patients were followed to 1 year. Across treatment groups, patients did not differ in age, gender and closed and open fracture types (I-IIIB). The overall event rate was 17.8% (13.7% closed, 26.5%, open fractures). A significant subgroup interaction effect in patients with open versus closed fractures (p=0.01) mandated a separate analysis for each subgroup. In 826 patients with closed fractures, patients with a reamed nail had a relative risk reduction of 33% (95%CI: 4–53%, P=0.03). This treatment effect was largely driven by differential autodynamization rates (rel. risk: 0.42, p=0.01). Among 400 patients with open fractures, there was a trend towards an increased risk of an event (rel. risk=1.27, p=0.16) for those who received a reamed nail.

Conclusion: Our overall incidence of revision surgery was lower than reported in previous studies. Possible reasons for the overall lower event rates in SPRINT are:

standardization of surgical and post-surgical care resulted in superior care among the SPRINT centres and surgeons and

Purpose: Although blinding of outcome assessors is crucial to minimize bias in clinical trials, the majority of surgical trials do not blind these individuals in part due to practical difficulties inherent in surgical interventions. We devised and tested techniques to blind outcome assessors in trials of femoral neck fracture fixation.

Method: We developed three techniques to mask radiographs of femoral neck fractures fixated with cancellous screws or dynamic hip screws: Blackout, Subtraction, and Overlay. 50 orthopaedic trauma surgeons assessed 32 radiographs blinded with each of these techniques. We considered:

The ability to mask the surgeons (the proportion of radiographs in which the surgeons were able to correctly identify the implant and the Bang Blinding Index);

Results: All three techniques achieved low proportions of correct identification of cancellous or dynamic screws (14.9% for Blackout, 26.9% for Subtraction, 22.1% for Overlay) and high proportions of “don’t know” responses (72.3%, 48.4%, 52.8% respectively). The Bang Blinding Indices were close to 0 (perfect blinding) for all three techniques (−0.024 to 0.008). The interrater reliability of quality of reduction in the blinded images (ICC = 0.55 – 0.57) was similar to the reliability of the unblinded radiographs (ICC = 0.60). Surgeons perceived the Overlay images as much more difficult to rate in 6.9% of radiographs, compared with 9.7% of Subtraction images (p=0.25) and 28.0% of Blackout images (p< 0.001).

Conclusion: Three techniques of blinding radiographs of femoral neck fractures successfully mask surgeons to the type of implant fixated, do not compromise reliability of reduction ratings, and do not make the rating process substantially more difficult. Trialists should explore creative approaches such as these to blind as many individuals as possible when designing trials, and should incorporate rigorous approaches to testing the success of blinding.

Purpose: Femoral neck fracture collapse and shortening has been a desired effect of parallel screw fixation to promote healing. While some degree of compression might be beneficial, it remains unknown whether the effects of uncontrolled femoral neck shortening leads to detectable functional impairment. We aimed to evaluate the effect of shortening and varus collapse after cancellous screw fixation of femoral neck fractures on patient functional status and quality of life.

Method: The databases of four University Hospitals were screened to identify patients with a healed isolated femoral neck fracture. Patients were contacted by telephone to complete Short-form 36(SF36) and Euroquol-5D(EQ5D) questionnaires (Primary outcome: SF36 physical functioning score[PF]). Femoral neck shortening and varus collapse were assessed by three independent reviewers blinded to functional outcome results based on the latest follow-up radiographs and categorized into three grades: None/Mild (within 5mm/5°), Moderate (5–10mm/5–10°), and Severe (> 10mm/> 10°). The minimal clinically important difference for SF36 PF score equals 12 points (1/2 of Standard deviation).

Results: Out of 660 patients screened at all four sites 70 met the inclusion criteria and were available for follow-up. The average follow-up was 20 months and an the average age was 71 years. Overall, there were 24/70 patients with none/mild femoral neck shortening, 25/70 with moderate shortening and 21/70 with severe shortening. Patients with severe shortening of their hip had significantly lower SF36 physical functioning scores (No/Mild vs. Severe shortening: 74 vs. 42 points, p=0.01). Similar important effects occurred with moderate shortening suggesting a gradient effect (No/Mild vs. Moderate shortening: 74 vs. 53 points). Some degree of varus collapse occurred in 39% of the patients and correlated moderately with the occurrence of shortening (r=0.66, p< 0.001).

Conclusion: A large proportion of displaced and undisplaced femoral neck fractures fixed with cancellous screws heal in a shortened position (66%) and varus (39%). The differences in function we observed represent patient important declines and suggest that uncontrolled sliding with cancellous screw fixation has limitations.

Purpose: The CONSORT statement for the reporting of randomized controlled trials (RCTs) has limitations in its applicability to non-pharmacological trials. In response, the CLEAR NPT, a checklist that provides guidelines for the reporting of RCTs in surgery, has been developed. We aimed to

apply the CLEAR NPT to orthopaedic RCTs across multiple journals from 2004–2005, and

We hypothesized that “lack of reporting” did not necessarily correlate with “not being conducted”.

Method: We searched for relevant orthopaedic RCTs across eight journals (four Orthopaedic, four General Medicine) in the period from January 2004 through December 2005. We applied the CLEAR NPT to all eligible studies. We contacted authors to determine what methodological safeguards were actually used, especially when details remained unclear from the publication.

Results: We included eighty-seven RCTs from eightyfive scientific reports. In assessing the RCTs with the CLEAR NPT, seventy-three (84%) studies had unclear reporting of allocation concealment. Only seventeen (20%) studies made mention of operator skill or experience. Participant, ward staff, rehabilitation staff, clinical outcome assessor and non-clinical outcome assessor blinding were found to be unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%) and thirty-three (38%) studies respectively. Authors from forty-three RCTs responded to our survey. In direct contact, authors reported adequate allocation concealment 41% (95% CI = 25–58%) of the time when this was unclear from the RCT report. 70% of authors acknowledged that they had set objective measures such as minimum case criteria and/or comparison to good clinical outcomes. Authors specified that they had blinded relevant groups 28–40% of the time, despite unclear reporting in the publications.

Conclusion: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias reducing safeguards not reported in an RCT did not occur. Our study reinforces the need for a tool like the CLEAR NPT to assess the methodology of surgical trials.