header advert
Results 61 - 80 of 89
Results per page:
Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 499 - 499
1 Oct 2010
Siebelt M Bhandari M Bloem R Pilot P Poolman R Siebelt T
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 549 - 549
1 Oct 2010
Hoang-Kim A Beaton D Bhandari M Kulkarni A Santone D Schemitsch E
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 71 - 72
1 Mar 2010
Hoang-Kim A Beaton D Bhandari M Santone D Schemitsch E
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 16 - 17
1 Mar 2010
Bhandari M Sprague S Dosanjh S D’Aurora V Shearer H Brink O Mathews D
Full Access

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,

Attitude of Orthopaedic Surgeon Towards Victims and Batterers and

Clinical Relevance of IPV in Orthopaedic Surgery.

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 6 - 6
1 Mar 2010
Petrisor B Bhandari M Schemitsch EH Sprague S Sanders D Jeray K Hanson B
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 70 - 70
1 Mar 2010
Bhandari M Chan S
Full Access

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

survey authors when items in the CLEAR NPT were not reported, to determine if they were actually conducted.

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

proscription of surgery until after 6 months. Optimizing peri-operative care and avoiding premature re-operation may substantially decrease the need for re-operation in tibial fracture patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 7 - 7
1 Mar 2010
Bhandari M Karanicolas PJ Walter SD Heels-Ansdell D Guyatt GH
Full Access

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);

Surgeons’ ability to accurately rate the quality of reduction in blinded images;

Surgeons’ perceptions of difficulties rating the blinded images.

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.


Full Access

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

survey authors when items in the CLEAR NPT were not reported to determine if they were actually conducted.

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 6 - 6
1 Mar 2010
Zlowodzki M Brink O Switzer J Wingerter S James J Bruinsma DR Petrisor BA Kregor PJ Bhandari M
Full Access

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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 250 - 250
1 May 2009
De Beer J Bhandari M Devereaux P Gulenchyn K Montgomery AG
Full Access

Prior to TJR, clinical cardiovascular risk assessment is typically limited by severe exercise restrictions. Noninvasive pharmacological cardiovascular stress tests may predict major perioperative cardiovascular events in patients undergoing orthopaedic surgery. We undertook a pilot study to inform the feasibility of a large prospective cohort study.

Patients were eligible if they were aged > forty-five, undergoing elective TJR, and had known atherosclerotic disease or risk factors for atherosclerotic disease. We recruited patients at the Hamilton Health Sciences, Henderson Hospital. Prior to surgery patients underwent dipyridamole stress perfusion imaging and dobutamine stress echocardiography. For both tests the interpreters evaluated seventeen myocardial segments and were blinded to information about patients’ clinical risk factors. The attending surgeons and research personnel following patients after surgery were blinded to results of the noninvasive pharmacological cardiovascular stress tests. All patients had an ECG performed and troponin T drawn six to twelve hours postoperatively and on the first, second and third days after surgery.

Starting in November 2005 we recruited thirty patients over six months; seventeen (57%) patients were male, twenty-one (70%) underwent TKA, and nine (30%) underwent THA. The length of surgery was seventy-two (SD 38) minutes and the length of hospital stay was five (SD 3) days. We successfully followed all patients to thirty days after surgery. Three patients (10%; 95% CI, 3–26%) suffered a perioperative myocardial infarction. Twenty nine patients underwent dipyridamole stress perfusion imaging prior to surgery; a reversible defect involving 30–50% of the myocardium increased the likelihood of a perioperative myocardial infarction (likelihood ratio [LR] 4.0; 95% CI, 1.2–13.3). Twenty-six patients underwent dobutamine stress echo-cardiography; a reversible defect increased the likelihood of a perioperative myocardial infarction (LR 4.0; 95% CI, 0.7–22.9).

This pilot study demonstrates the need for, and feasibility of, a large prospective cohort study to determine if preoperative noninvasive pharmacological cardiovascular stress testing has additional predictive value, beyond clinical variables, for the occurrence of myocardial infarction in patients undergoing major hip and knee surgery.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 237 - 237
1 May 2009
Bhandari M Siegel J Sung J Tornetta P
Full Access

We aimed to quantify the sample sizes and magnitude of treatment effects in a review of orthopaedic randomised trials with statistically significant findings.

We conducted a comprehensive search (PubMed, Cochrane) for all randomised controlled trials between 1/1/95 to 12/31/04. For continuous outcome measures (ie functional scores), we calculated effect sizes (mean difference/standard deviation). Dichotomous variables (ie infection, nonunion) were summarised as absolute risk differences and relative risk reductions (RRR). Effect sizes > 0.80 and RRRs> 50% were defined as large effects.

Our search yielded 433 RCTs, of which 76 RCTs with statistically significant findings on 184 outcomes (122 continuous/62 dichotomous outcomes) met study eligibility criteria. The mean effect size across studies with continuous outcome variables was 1.7 (95% confidence interval: 1.43–1.97). Almost one in three results, despite being reported as statistically significant did meet the definition of a large effect size (ES< 0.80). For dichotomous outcomes, the mean risk difference was 30% (95%confidence interval:24%–36%) and the mean relative risk reduction was 61%.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 254 - 254
1 May 2009
Bederman SS McKee MD Schemitsch EH Bhandari M
Full Access

Fat embolism syndrome (FES) is a potentially lethal condition commonly seen in poly-traumatised patients, particularly those with multiple long-bone fractures. Treatment has centered around supportive care and early fracture fixation. Several clinical small trials have suggested corticosteroids benefit patients with FES but its use remains controversial. Our objective was to determine the effect of corticosteroids in preventing FES in patients with multiple long-bone fractures.

We conducted a meta-analysis of randomised trials, searching computerised databases for published studies from 1966–2006. Additionally, we performed hand searches of major orthopaedic journals, meeting proceedings, and texts. Our primary outcome was the rate of FES. Secondary outcomes included presence of hypoxia, petechiae, mortality, infection, and delayed union.

Of the one hundred and four studies identified, nine were potentially eligible, and only seven met all our eligibility criteria. From our pooled analysis of three hundred and eighty-nine patients, we found that corticosteroids reduced the risk of FES by 78% (95%CI: 43–92%, heterogeneity p-value=0.62, I2=10%) and that only eight patients needed to be treated (NNT=7.5) to prevent one case of FES (95%CI: five to thirteen patients). We did not find any significant differences in the rates of mortality, infection, or delayed union.

The current evidence suggests that the use of corticosteroids is beneficial in the prevention of fat embolism syndrome in patients with multiple long-bone fractures. The use of corticosteroids does not appear to significantly increase the risk of complications although a confirmatory large randomised trial is needed.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 17 - 17
1 Mar 2009
Poolman R Keijser L de Waal Malefijt M Blankevoort L Farrokhyar F Bhandari M
Full Access

Background: The selection of presentations at orthopedic meetings is an important process. If the peer reviewers do not consistently agree on the quality score, the review process is arbitrary and open to bias. The aim of this study was:

1) To describe the inter reviewer agreement of a previously designed scoring scheme to rate abstracts submitted for presentation at the Dutch Orthopedic Association.

2) To test if quality of reporting of submitted abstracts increased in the years after the introduction of the scoring scheme.

3) To examine if a review process with a larger workload had lower inter rater agreement.

Methods: We calculated intraclass correlation coefficients (ICC) to measure the level of agreement among reviewers using the International Society of the Knee (ISK) abstract quality of reporting system. Acceptance rate and quality of the abstracts are described.

Results: Of 419 abstracts 229 (55%) were accepted. Inter-reviewer agreement to rate abstracts was substantial 0.68 (95%CI 0.47, 0.83) to almost perfect 0.95 (95%CI 0.92, 0.97) and did not change over the eligible time period. Less abstracts were accepted after 2004 (p = 0.039). The mean ISK abstract score, maximally 100 points, for accepted abstracts ranged from 60.4 (95%CI 57.7, 63.0) to 63.8 (95% CI 62.0, 65.7). The mean ISK abstract score for rejected abstracts varied from 45.8 (95%CI 40.3, 51.2) to 50.6 (95% CI 46.5, 54.8). Both scores for accepted and rejected abstracts did not change over time. Workload of the reviewers did not influence their level of agreement (p=0.167).

Interpretation: The ISK abstract rating system has an excellent inter observer agreement. Other scientific orthopedic meetings could adopt this ISK rating system for further evaluation in local or international setting.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 18 - 18
1 Mar 2009
Poolman R Struijs P Krips R Sierevelt I Marti R Farrokhyar F Zlowodzki M Bhandari M
Full Access

Background: While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold:

1) to examine the reporting of outcome measures in orthopaedic trials,

2) to determine the feasibility of blinding in published orthopaedic trials and

3) to examine the association between the magnitude of treatment differences and methodological safeguards such as blinding.

Specifically, we focused on an association between blinding of outcome assessment and the size of the reported treatment effect; in other words: does blinding of outcome assessors matter?

Methods: We reviewed 32 identified RCTs published in the Journal of Bone and Joint Surgery (American Volume), in 2003 and 2004 for the appropriate use of outcome measures. These RCTs represented 3.4% (32/938) of all studies published during that time period. All RCTs were reviewed by two of us for:

1) the outcome measures used and

2) the use of a methodological safeguard: blinding.

We calculated the magnitude of treatment effect of blinded compared to un-blinded outcome assessors.

Results: The methodological validation and clinical usefulness of the clinician-based, patient-based, and generic outcome instruments varied. Ten of the 32 RCTs (31%) used a modified outcome instrument. Of these 10 trials, 4 (40%) failed to describe how the outcome instrument was modified. Nine (90%) of the 10 articles did not describe how their modified instrument was validated and retested. Sixteen (50%) of the 32 RCTs did not report blinding of outcome assessors where blinding would have been possible. Among those studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects (standardized mean difference 0.76 versus 0.25, p=0.01). Similarly, in those studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects (Odds ratio 0.13 versus 0.42, unblinded versus blinded, p< 0.001). The ratio of odds ratios (unblinded to blinded) was 0.31 suggesting that unblinded outcomes assessment was associated with an exaggeration of the benefit of a treatment’s effectiveness in our cohort of studies.

Conclusion: Reported outcomes in RCTs are often modified and rarely validated. Half of the RCTs did not blind outcome assessors even though blinding of outcome assessors would have been feasible in each case. Treatment effects may be exaggerated if outcome assessors are unblinded. Emphasis should be placed on detailed reporting of outcome measures to facilitate generalization. Outcome assessors should be blinded where possible to prevent bias.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 18 - 18
1 Mar 2009
Poolman R Struijs P Krips R Sierevelt I Lutz K Zlowodzki M Bhandari M
Full Access

Background: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals.

Methods: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the four highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003–2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score.

Results: We found that only the Journal of Bone and Joint Surgery–American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p> 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC=0.80, 95%CI:0.60 to 0.90).

Conclusions: Our findings suggest that readers should not assume that

1) studies labelled as Level I have high reporting quality and

2) Level I studies have better reporting quality than Level II studies.

One should address methodological safeguards individually.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 111 - 112
1 Mar 2009
Poolman R Sierevelt I Farrokhyar F Mazel J Blankevoort L Zlowodzki M Bhandari M
Full Access

Background: The Journal of Bone and Joint Surgery, American Edition (the Journal) recently initiated a section called “Evidence-Based Orthopaedics”. Furthermore, a Levels of Evidence rating is now used in the Journal to help readers in clinical decision-making. Little is known if this recent emphasis of Evidence-based Medicine (EBM) influenced surgeons’ perceptions about and competence in evidence-based medicine. Therefore, we examined perceptions and competence in evidence-based medicine among Dutch orthopaedic surgeons.

Methods: Members of the Dutch Orthopaedic Association were surveyed to examine surgeons’ attitudes towards evidence-based medicine and competence in evidence-based medicine. We evaluated perceptions using a newly developed instrument tailored to surgical practice. Univariate analysis, and a multivariable analysis using Generalized Estimating Equations were performed to model the competence instrument.

Results: 367 Surgeons responded (60%). Orthopaedic surgeons welcomed evidence-based medicine. Practical evidence-based medicine resources were perceived as the best methods to move from eminence-based to evidence-based practice. Four variables were significantly and positively associated with the competence instrument:

1) younger age, particularly age between 36 and 45 years,

2) experience of less than 10 years,

3) having a PhD degree, and

4) working in an academic or teaching setting.

The majority of the respondents (65%) were aware of the Journal’s evidence-based medicine section, and 20% used the Journal’s evidence-based medicine abstracts in clinical decision-making. This increased awareness in evidence-based medicine was also reflected in a frequent use of Cochrane reviews in clinical decision-making (27%). Surgeons who used the Journal’s evidence-based medicine abstracts and Cochrane reviews had significantly higher competence scores.

Conclusions: Evidence-based medicine is welcomed by Dutch orthopaedic surgeons. Recent emphasis of evidence-based medicine is reflected in an increased awareness about the Journal’s evidence-based medicine section, Levels of Evidence, and the largest evidence-based medicine resource: Cochrane reviews. Younger orthopaedic surgeons had better knowledge about evidence-based medicine. Development and use of evidence-based resources as well as pre-appraised summaries like the Journal’s evidence-based medicine abstracts and Cochrane reviews were perceived as the best way to move from eminence based- to evidence-based orthopaedic practice.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 31 - 31
1 Mar 2008
Audigé L Griffin D Bhandari M Kellam J Rüedi T
Full Access

We applied the technique of path analysis to investigate the effect of potential prognostic factors, including injury characteristics and treatment choices, on the risk of delayed healing or non-union after operative treatment of tibial shaft fractures.

Data were collected in a prospective observational study of 41 Swiss hospitals over two years, and analysed by regression models and path analysis. Path analysis is a technique to visualize the most important associations between clinical factors and outcome in a ‘causal path diagram’ that summarises the most likely cause and effect relationships.

Factors having a direct relationship with the occurrence of delayed healing or non-union included open fracture (RR 6.7), distal shaft location (RR 2.2), and initial treatment with an external fixator (RR 2.8). There were many other significant inter-relationships within the final diagram. For example, the choice of treatment was related to factors such as fracture aetiology, AO classification, location and skin injury. Fracture classification was not associated with delayed healing and non-union after adjustment for other factors including treatment choice.

The association of hypothesised risk factors, such as soft tissue injury and fracture location, with delayed healing or non-union was confirmed and measured. This study suggested that the use of an external fixator had a direct, negative effect on outcome, and that the use of nails or plates might contribute to delayed healing or non-union by their association with post-operative diastasis. These observations support this first use of path analysis in orthopaedics as a powerful technique to interpret data from an observational study.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 42 - 42
1 Mar 2008
Bhandari M Devereaux P Swiontkowski M Tornetta P Obremskey W Koval K Sprague S Schemitsch E Guyatt G
Full Access

In a meta-analysis of fourteen trials (N=1901 patients) in patients with displaced hip fractures, we identified significant reductions in the risk of revision surgery with internal fixation compared to arthroplasty. A trend towards increased mortality with arthroplasty was identified.

The purpose of this study was to determine the effect of arthroplasty (hemi-arthroplasty, bipolar arthroplasty and total hip arthroplasty) in comparison to internal fixation for displaced femoral neck fractures on rates of mortality and revision surgery

Arthroplasty for displaced femoral neck fractures, in comparison to internal fixation, significantly reduces the risk of revision surgery at the cost of greater infection rates, blood loss and operative time, and a possible increase in early mortality.

Over 220,000 fractures of hip occur per year in North America representing an annual seven billion dollar cost to the health care system. Current evidence suggests internal fixation may reduce mortality risk at the consequence of increased revision rates. A large trial is needed to resolve this issue.

We searched computerized databases (MEDLINE, COCHRANE and SCISEARCH) for published clinical studies from 1969–2002 and identified additional studies through hand searches of major orthopaedic journals, bibliographies of major orthopaedic texts and personal files. We found a non-significant trend toward an increase in the relative risk of dying with arthroplasty when compared to internal fixation (relative risk=1.27, 95% confidence interval, 0.84–1.92, p = 0.25; homogeneity p= 0.45). Arthroplasty appeared to increase the risk of dying when compared to pin and plate, but not in comparison to internal fixation using screws (relative risk= 1.75 vs 0.86, respectively, p< 0.05). Fourteen trials provided data on revision surgery (n=1901 patients). The relative risk of revision surgery with arthroplasty was 0.23 (95% confidence interval, 0.13–0.42, p = 0.0003, homogeneity p = < 0.01).