Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]

Background: Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years.

Design: A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the Roland-Morris Disability Questionnaire; timed 'Up and Go' test; and adverse effects. The presence of new fractures will be assessed by radiographs of the thoracic and lumbar spine performed at 12 and 24 months.

Discussion: The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice.

Trial registration: Australian Clinical Trial Register # [ACTRN012605000079640]

Methodological reflections on using pilot data from fracture patients to develop a qualitative study

Background: Qualitative studies are particularly valued for their exploratory nature but, like other research methods, they do require careful planning to ensure rigorous study design. Our objective was to undertake a pilot study to inform the development of a larger qualitative study.

Results: We conducted a series of brief interviews with out-patients in a hospital setting. The interviews were designed to elicit superficial information about whether (and how) post-fracture osteoporosis investigation and/or treatment were being initiated among patients receiving treatment or follow-up for a current or recent fracture. We used thematic analysis to identify key themes in the data that related to the broader research questions. We analysed data obtained from 11 out of a total of 12 interviews conducted. Participants were male and female, aged 19-83 years of age (median age 57 years). Participants attended 2-8 medical appointments to seek treatment and follow up for a current or recent fracture. The following four overarching themes emerged from thematic analysis of the data: fracture event, referral pathway, osteoporosis investigation and/or treatment, and communication by health practitioners and staff.

Conclusions: This pilot study was necessarily tentative and exploratory in nature, but provided a helpful snapshot of some typical experiences in the public health system following fracture. Several themes emerged for consideration in the design of the main study. Despite its critics, theoretical sampling and saturation continue to provide sustainable methods for ensuring that relevant themes and categories are covered in sufficient depth and breadth, appropriate to the needs of the study.

Prevention and treatment of infant and childhood vitamin D deficiency in Australia and New Zealand : a consensus statement

• Vitamin D deficiency has re-emerged as a significant paediatric health issue, with complications including hypocalcaemic seizures, rickets, limb pain and fracture.

• A major risk factor for infants is maternal vitamin D deficiency. For older infants and children, risk factors include dark skin colour, cultural practices, prolonged breastfeeding, restricted sun exposure and certain medical conditions.

• To prevent vitamin D deficiency in infants, pregnant women, especially those who are dark-skinned or veiled, should be screened and treated for vitamin D deficiency, and breastfed infants of dark-skinned or veiled women should be supplemented with vitamin D for the first 12 months of life.

• Regular sunlight exposure can prevent vitamin D deficiency, but the safe exposure time for children is unknown.

• To prevent vitamin D deficiency, at-risk children should receive 400 IU vitamin D daily; if compliance is poor, an annual dose of 150 000 IU may be considered.

• Treatment of vitamin D deficiency involves giving ergocalciferol or cholecalciferol for 3 months (1000 IU/day if < 1 month of age; 3000 IU/ day if 1-12 months of age; 5000 IU/day if > 12 months of age).

• High-dose bolus therapy (300 000-500 000 IU) should be considered for children over 12 months of age if compliance or absorption issues are suspected.

The post-fracture care gap among Canadian First Nations peoples : a retrospective cohort study

Summary Despite targeted attempts to reduce post-fracture care gaps, we hypothesized that a larger care gap would be experienced by First Nations compared to non-First Nations people. First Nations peoples were eight times less likely to receive post-fracture care compared to non-First Nations peoples, representing a clinically significant ethnic difference in post-fracture care.

Introduction First Nations peoples are the largest group of aboriginal (indigenous or native) peoples in Canada. Canadian First Nations peoples have a greater risk of fracture compared to non-First Nations peoples. We hypothesized that ethnicity might be associated with a larger gap in post-fracture care.

Methods Non-traumatic major osteoporotic fractures for First Nations and non-First Nations peoples aged ≥50 years were identified from a population-based data repository for Manitoba, Canada between April 1996 and March 2002. Logistic regression analysis was used to examine the probability of receiving a BMD test, a diagnosis of osteoporosis, or beginning an osteoporosis-related drug in the 6 months post-fracture.

Results A total of 11,234 major osteoporotic fractures were identified; 502 occurred in First Nations peoples. After adjustment for confounding covariates, First Nations peoples were less likely to receive a BMD test [odds ratio (OR) 0.1, 95% confidence interval (CI), 0.0–0.5], osteoporosis-related drug treatment (OR, 0.5; 95% CI, 0.3–0.7), or a diagnosis of osteoporosis (OR, 0.5; 95% CI, 0.3–0.7) following a fracture compared to non-First Nations peoples. Females were more likely to have a BMD test (OR, 5.0; 95% CI, 2.6–9.3), to be diagnosed with osteoporosis (OR, 1.7; 95% CI, 1.5–2.0), and to begin drug treatment (OR, 4.1; 95% CI, 2.7–6.4) compared to males.

Conclusions An ethnicity difference in post-fracture care was observed. Further work is needed to elucidate underlying mechanisms for this difference and to determine whether failure to initiate treatment originates with the medical practitioner, the patient, or a combination of both. It is imperative that all residents of Manitoba receive efficacious and equal care post-fracture, regardless of ethnicity.

Interobserver reliability of radial head fracture classification : two-dimensional compared with three-dimensional CT

Background: The Broberg and Morrey modification of the Mason classification of radial head fractures has substantial interobserver variation. This study used a large web-based collaborative of experienced orthopaedic surgeons to test the hypothesis that three-dimensional reconstructions of computed tomography (CT) scans improve the interobserver reliability of the classification of radial head fractures according to the Broberg and Morrey modification of the Mason classification.

Methods: Eighty-five orthopaedic surgeons evaluated twelve radial head fractures. They were randomly assigned to review either radiographs and two-dimensional CT scans or radiographs and three-dimensional CT images to determine the fracture classification, fracture characteristics, and treatment recommendations. The kappa multirater measure (κ) was calculated to estimate agreement between observers.

Results: Three-dimensional CT had moderate agreement and two-dimensional CT had fair agreement among observers for the Broberg and Morrey modification of the Mason classification, a difference that was significant. Observers assessed seven fracture characteristics, including fracture line, comminution, articular surface involvement, articular step or gap of ≥2 mm, central impaction, recognition of more than three fracture fragments, and fracture fragments too small to repair. There was a significant difference in kappa values between three-dimensional CT and two-dimensional CT for fracture fragments too small to repair, recognition of three fracture fragments, and central impaction. The difference between the other four fracture characteristics was not significant. Among treatment recommendations, there was fair agreement for both three-dimensional CT and two-dimensional CT.

Conclusions: Although three-dimensional CT led to some small but significant decreases in interobserver variation, there is still considerable disagreement regarding classification and characterization of radial head fractures. Three-dimensional CT may be insufficient to optimize interobserver agreement.

Primary hemiarthroplasty for treatment of proximal humeral fractures

Background: Primary hemiarthroplasty of the shoulder is used to treat complex proximal humeral fractures, although the reported functional results following this method of treatment have varied widely. The aim of this study was to prospectively assess the prosthetic survival and functional outcomes in a large series of patients treated with shoulder hemiarthroplasty for a proximal humeral fracture. By determining the factors that affected the outcome, we also aimed to produce models that could be used clinically to estimate the functional outcome at one year following surgery.

Methods: A thirteen-year observational cohort study of 163 consecutive patients treated with hemiarthroplasty for a proximal humeral fracture was performed. Twenty-five patients died or were lost to follow-up in the first year after treatment, leaving 138 patients who had assessment of shoulder function with use of the modified Constant score at one year postinjury.

Results: The overall rate of prosthetic survival was 96.9% at one year, 95.3% at five years, and 93.9% at ten years. The overall median modified Constant score was 64 points at one year, with a typically good score for pain relief (median, 15 points) and poorer scores, with a greater scatter of values, for function (median, 12 points), range of motion (median, 24 points), and muscle power (median, 14 points). Of the factors that were assessed immediately after the injury, only patient age, the presence of a neurological deficit, tobacco usage, and alcohol consumption were significantly predictive of the one-year Constant score (p < 0.05). Of the factors that were assessed at six weeks postinjury, those that predicted the one-year Constant score included the age of the patient, the presence of a persistent neurological deficit, the need for an early reoperation, the degree of displacement of the prosthetic head from the central axis of the glenoid seen radiographically, and the degree of displacement of the tuberosities seen radiographically.

Conclusions: Primary shoulder hemiarthroplasty performed for the treatment of a proximal humeral fracture in medically fit and cooperative adults is associated with satisfactory prosthetic survival at an average of 6.3 years. Although the shoulder is usually free of pain following this procedure, the overall functional result, in terms of range of motion, function, and power, at one year varies. A good functional outcome can be anticipated for a younger individual who has no preoperative neurological deficit, no postoperative complications, and a satisfactory radiographic appearance of the shoulder at six weeks. The results are poorer in the larger group of elderly patients who undergo this procedure, especially if they have a neurological deficit, a postoperative complication requiring a reoperation, or an eccentrically located prosthesis with retracted tuberosities.

Severe impacted valgus proximal humerus fractures : results of operative treatment

Background: The functional results associated with nonoperative treatment of severely impacted valgus fractures of the proximal part of the humerus are poor, and these injuries are difficult to treat with minimally invasive percutaneous fixation techniques. The aim of this study was to review the functional and radiographic results and complications of a new operative technique in a series of twenty-five patients.

Methods: Over a two-year period, we treated twenty-nine patients with a severely impacted valgus fracture of the proximal part of the humerus. Three patients were lost to follow-up and one died, leaving twenty-five patients who were available for the study. In all of the fractures, the head-shaft angle had been tilted into =160° of valgus and the greater tuberosity was displaced by >1 cm. All patients were treated with open reduction of the fracture, and the space created behind the humeral head was filled with Norian Skeletal Repair System (SRS) bone substitute. The fractures were stabilized with either screws or buttress plate fixation. Associated rotator cuff tears were repaired. All patients underwent functional outcome assessment with use of the Constant, DASH (Disabilities of the Arm, Shoulder and Hand), and SF-36 (Short Form-36) scores at one year, and twelve patients were followed for two years.

Results: All fractures united within the first year, all reductions were maintained, and no patient had signs of osteonecrosis of the humeral head on the latest follow-up radiographs. At one year, the median Constant score was 80 points and the median DASH score was 22 points. The functional results continued to be satisfactory in the twelve patients who were followed for two years. The results in our series were better than those achieved in studies of nonoperative treatment of similar fracture configurations. There were six clinically relevant complications, although none required a reoperation and all six patients had a satisfactory short-term functional outcome.

Conclusions: Internal fixation of severely impacted valgus fractures of the proximal part of the humerus, supplemented by Norian SRS bone substitute to fill the proximal humeral metaphyseal defect, produces good early functional and radiographic outcomes. Additional follow-up will be required to assess whether these initially satisfactory outcomes are maintained over the longer term.

Level of Evidence: Therapeutic study, Level IV (case series [no, or historical, control group]). See Instructions to Authors for a complete description of levels of evidence.

Interobserver reliability of coronoid fracture classification : two-dimensional versus three-dimensional computed tomography

Purpose : This study tests the hypothesis that 3-dimensional computed tomography (CT) reconstructions improve interobserver agreement on classification and treatment of coronoid fractures compared with 2-dimensional CT.

Methods : A total of 29 orthopedic surgeons evaluated 10 coronoid fractures on 2 occasions (first with radiographs and 2-dimensional CT and then with radiographs and 3-dimensional CT), separated by a minimum of 2 weeks. Surgeons classified fractures according to the classifications of Regan and Morrey and of O'Driscoll et al., identified specific characteristics, recommended the most appropriate treatment approach, and made treatment recommendations. The kappa multirater measure (κ) was calculated to estimate agreement between observers.

Results : Regardless of the imaging modality used, there was fair to moderate agreement for most of the observations. Three-dimensional CT improved interobserver agreement in Regan and Morrey's classsication (κ3-dimensional = 0.51 vs κ2-dimensional = 0.40; p < .001) and O'Driscoll et al.'s classifications (κ3-dimensional = 0.48 vs κ2-dimensional = 0.42; p = .009). There were trends toward better reliability for 3-dimensional reconstruction in recognition of coronoid tip fractures (κ3-dimensional = 0.19, κ2-dimensional = 0.03; p = .268), comminution (κ3-dimensional = 0.41 vs κ2-dimensional = 0.29; p = .133), and impacted fragments (κ3-dimensional = 0.39 vs κ2-dimensional = 0.27; p = .094), and in surgeons' opinions on the need for something other than screws or plate for surgical fixation (κ3-dimensional = 0.31 vs κ2-dimensional = 0.15; p = .138). Interobserver agreement on treatment approach was better with 2-dimensional CT (κ3-dimensional = 0.27, κ2-dimensional = 0.32; p = .015).

Conclusions : Three-dimensional CT reconstructions improve interobserver agreement with respect to fracture classification compared with 2-dimensional CT.

Resolving controversies in hip fracture care : the need for large collaborative trials in hip fractures

Summary: Hip fractures are a significant cause of morbidity and mortality worldwide and the burden of disability associated with hip fractures globally vindicates the need for high-quality research to advance the care of patients with hip fractures. Historically, large, multi-centre randomized controlled trials have been rare in the orthopaedic trauma literature. Similar to other medical specialties, orthopaedic research is currently undergoing a paradigm shift from single centre initiatives to larger collaborative groups. This is evident with the establishment of several collaborative groups in Canada, in the United States, and in Europe, which has proven that multi-centre trials can be extremely successful in orthopaedic trauma research.

Despite ever increasing literature on the topic of his fractures, the optimal treatment of hip ftractures remains unknown and controversial. To resolve this controversy large multi-national collaborative randomized controlled trials are required. In 2005, the International Hip Fracture Research Collaborative was officially established following funding from the Canadian Institute of Health Research International Oppurtunity Program with the mandate of resolving controversies in hip fracture management. This manuscript will describe the need, the information, the organization, and the accomplishments to date of the International Hip Fracture Research Collaborative.

Surgical treatment of lateral clavicle fractures associated with complete coracoclavicular ligament disruption: clinico-radiological outcomes of acromioclavicular joint sparing and spanning implants

Distal clavicle fracture associated with complete coracoclavicular ligament disruption represents an unstable injury, and osteosynthesis is recommended. This study was performed (1) to retrospectively analyse the clinico-radiological outcomes of two internal fixation techniques, and (2) to identify and analyse radiographic fracture patterns of fracture that are associated with this injury. Conclusions: Internal fixation of this fracture pattern is associated with a high union rate and favorable clinical outcomes with both techniques. A combination of distal radius plate and ligament reconstruction device resulted in stable fixation and significantly lower reoperation rates, and should be used when fracture geometry permits (Types 1 and 2).

Is lower income associated with an increased likelihood of qualification for treatment for osteoporosis in Canadian women?

The authors examined whether low income was associated with an increased likelihood of treatment qualification for osteoporotic fracture probability determined by Canada FRAX in women aged ≥50 years. A significant negative linear association was observed between income and treatment qualification when FRAX included bone mineral density (BMD), which may have implications for clinical practice.

Interobserver Variability in the Treatment of Little Finger Metacarpal Neck Fractures

Purpose To address the null hypothesis that surgeons shown radiographs of little finger metacarpal neck fractures with measured fracture angulation would recommend surgery as often as surgeons shown unmarked radiographs. Methods Members of the Science of Variation Group, an international collaboration of fully trained orthopedic and trauma surgeons, were asked to review 20 little finger metacarpal neck fracture cases, which included a vignette and 3 high-quality radiographs. Members were then randomized to review radiographs with or without measured fracture angulation on the lateral view and select operative or nonoperative management. Results Surgeons shown radiographs with measured angulation were more likely to recommend surgery, and there was less variability among these surgeons, particularly for fractures with less angular deformity. Conclusions Measured fracture angulation has a small but significant influence on treatment recommendations for little finger metacarpal neck fractures.

A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people : protocol for the ASPREE-Fracture substudy

Background Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people. Methods ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture-vertebral, hip and non-vert-non-hip-occurring post randomisation. Fall-related hospital presentations are a secondary outcome. Discussion This substudy will determine whether a widely available, simple and inexpensive health intervention-aspirin-reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention.

The effect of surgical timing on the outcome of patients with neck of femur fracture

Aims: To investigate the effect of surgical timing (in hours versus after hours and weekdays versus weekends) on the outcome of patients with neck of femur fracture. Methods: Patients who were admitted to a single tertiary referral hospital for surgical management of femoral neck fractures over a continuous period from 1/11/2002 to 12/7/2012 were identified from medical records and the operating theatre database. Results: A consecutive series of 2334 patients were included in the study. Of the patients who underwent surgery during the weekday and during usual hours, 18 % (207/1135) experienced an adverse event, compared to 16 % (193/1199) outside of these times. The difference between the two groups was not significant (p = 0.17). The same conclusion was made for the comparison between those who had surgery during the week with those who had surgery on the weekend (17 %, 267/1546 and 17 %, 133/788, respectively, p > 0.05). The proportion of patients who underwent surgery during hours that experienced an adverse event was significantly higher than those undergoing surgery out of hours (18 %, 327/1789 and 13 %, 73/545, respectively, p = 0.0081). When adjusted for age, ASA score and pre-operative stay, there was no statistical difference between those different sub-groups. Conclusions: There was no difference in the rates of adverse events between patients who had surgery during hours and weekdays with those who had surgery after hours or weekends. The careful selection of patients with appropriate hospital staff, resources and adequate theatre access, surgery during after hours and weekends may be safely considered to prevent a delay in surgical treatment for patient with neck of femur fracture.

Fracture prediction from repeat BMD measurements in clinical practice

Summary: We investigated whether repeat BMD measurements in clinical populations are useful for fracture risk assessment. We report that repeat BMD measurements are a robust predictor of fracture in clinical populations; this is not affected by preceding BMD change or recent osteoporosis therapy. Introduction: In clinical practice, many patients selectively undergo repeat bone mineral density (BMD) measurements. We investigated whether repeat BMD measurements in clinical populations are useful for fracture risk assessment and whether this is affected by preceding change in BMD or recent osteoporosis therapy. Methods: We identified women and men aged ≥50 years who had a BMD measurement during 1990–2009 from a large clinical BMD database for Manitoba, Canada (n = 50,215). Patient subgroups aged ≥50 years at baseline with repeat BMD measures were identified. Data were linked to an administrative data repository, from which osteoporosis therapy, fracture outcomes, and covariates were extracted. Using Cox proportional hazards models, we assessed covariate-adjusted risk for major osteoporotic fracture (MOF) and hip fracture according to BMD (total hip, lumbar spine, femoral neck) at different time points. Results: Prevalence of osteoporosis therapy increased from 18 % at baseline to 55 % by the fourth measurement. Total hip BMD was predictive of MOF at each time point. In the patient subgroup with two repeat BMD measurements (n = 13,481), MOF prediction with the first and second measurements was similar: adjusted-hazard ratio (HR) per SD 1.45 (95 % CI 1.34–1.56) vs. 1.64 (95 % CI 1.48–1.81), respectively. No differences were seen when the second measurement results were stratified by preceding change in BMD or osteoporosis therapy (both p-interactions >0.2). Similar results were seen for hip fracture prediction and when spine and femoral neck BMD were analyzed. Conclusion: Repeat BMD measurements are a robust predictor of fracture in clinical populations; this is not affected by preceding BMD change or recent osteoporosis therapy.