header advert
Results 41 - 60 of 89
Results per page:
Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 560 - 561
1 Nov 2011
Petrisor B Bhandari M Kooistra BW Dijkman BG Sprague S
Full Access

Purpose: To investigate

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

if the sending modality (fax or email) would affect, the six-week response rate of an orthopaedic survey.

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

to receive their survey by fax or email.

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 575 - 575
1 Nov 2011
Bhandari M Kooistra BW Busse J Walter SD Tornetta P Schemitsch EH
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 582 - 582
1 Nov 2011
Bhandari M Dijkman BG Busse JW Walter SD
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 562 - 562
1 Nov 2011
Sprague S Rocca GD Dosanjh S Schemitsch EH Bhandari M
Full Access

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,

the attitude of the orthopaedic surgeon toward victims and batterers, and

the clinical relevance of intimate partner violence in orthopaedic surgery.

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%);

some women have personalities that cause the abuse (20%); and

the battering would stop if the batterer quite abusing alcohol (40%).

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 592 - 592
1 Nov 2011
Goldstein C Petis S Kowalczuk M Drew B Petrisor B Bhandari M
Full Access

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,

definition of successful lumbar fusion and

reliability, sensitivity and specificity of the investigations used to assess the spinal fusion.

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 590 - 591
1 Nov 2011
Schemitsch EH Bhandari M
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 593 - 593
1 Nov 2011
Goldstein C Petrisor B Drew B Bhandari M
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 592 - 592
1 Nov 2011
Hoang-Kim M Bhandari M Beaton DE Schemitsch EH
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 581 - 581
1 Nov 2011
Simunovic N Sprague S Guyatt GH Devereaux P Walter SD Schemitsch EH Bhandari M
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 561 - 561
1 Nov 2011
Simunovic N Bhandari M Kooistra BW Dijkman B
Full Access

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

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

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

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


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 574 - 574
1 Nov 2011
Bhandari M Bojan A Eckholm C Brink O Adili A Sprague S Hussain N Joensson A
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 560 - 560
1 Nov 2011
Schemitsch EH Bhandari M
Full Access

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

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

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

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


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 583 - 583
1 Nov 2011
Goulding K Poolman R Schemitsch EH Bhandari M Petrisor B
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 583 - 583
1 Nov 2011
Bhandari M Thompson DD Kaplan IV Paralkar VM Buljat G Sanders D Schwappach J Vukicevic S
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 279 - 280
1 Jul 2011
Slobogean G Bhandari M O’Brien PJ
Full Access

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).


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 281 - 281
1 Jul 2011
Wu V Huff H Bhandari M
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 256 - 256
1 Jul 2011
Simunovic N Sprague S Bhandari M
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 259 - 259
1 Jul 2011
Goldstein C Schemitsch EH Bhandari M Mathew G Petrisor B
Full Access

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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 164 - 164
1 May 2011
Buijze G Doornberg J Ham J Ring D Bhandari M Poolman R
Full Access

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 582 - 583
1 Oct 2010
Wei D Bhandari M Poolman R Rosenwasser M Wolfe V
Full Access

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.