Forearm bone mineral density and incidence of hip fractures in Swedish urban and rural men 1987-2002

Background: It is not known whether the recently described break in the trend in hip fracture incidence in many settings applies in both women and men, depends on changes in bone mineral density (BMD) or changes in other risk factors, or whether it is apparent in both urban and rural settings. Methods: We evaluated changes in annual hip fracture incidence from 1987 to 2002 in Swedish men aged ≥60 years in one urban (n=25,491) and one rural population (n=16,432) and also secular differences in BMD, measured by single-photon absorptiometry at the distal radius and multiple other risk factors for hip fracture in a population-based sub-sample of the urban and the rural men aged 60–80 years in 1988/89 (n=202 vs. 121) and in 1998/99 (n=79 vs. 69). Results: No statistically significant changes in the annual age-adjusted hip fracture incidence per 10,000 were apparent from 1987 to 2002 in urban (0.38 per year, 95% CI-0.12 to 0.88) or rural men (-0.05 per year, 95% CI -0.63 to 0.53). BMD was similar in 1988/89 and 1998/99 when examining both urban (-19.6 mg/cm², 95% CI -42.6 to 3.5) and rural (-23.0 mg/cm², 95% CI -52.1 to 6.1) men. Conclusions: Since no secular change in age-adjusted hip fracture incidence was found during the study period, a levelling off in hip fracture incidence is present also in Swedish men. Because BMD on a group level was similar in 1988/89 and 1998/99, changes in other risk factors ought to be either of minor importance or counteracted by changes in different risk factors.

Osteo-cise : Strong bones for life': protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures

Background : Osteoporosis affects over 220 million people worldwide, and currently there is no 'cure' for the disease. Thus, there is a need to develop evidence-based, safe and acceptable prevention strategies at the population level that target multiple risk factors for fragility fractures to reduce the health and economic burden of the condition.

Methods : The 'Osteo-cise: Strong Bones for Life' study will investigate the effectiveness and feasibility of a multi-component targeted exercise, osteoporosis education/awareness and behavioural change program for improving bone health and muscle function, and reducing falls risk in community-dwelling older adults at an increased risk of fracture. Men and women aged 60 years or above will participate in an 18-month randomised controlled trial comprising a 12-month structured and supervised community-based program and a 6-month 'research to practise' translational phase. Participants will be randomly assigned to either the 'Osteo-cise' intervention or a self-management control group. The intervention will comprise a multi-modal exercise program incorporating high velocity progressive resistance training, moderate impact weight-bearing exercise and high challenging balance exercises performed three times weekly at local community-based fitness centres. A behavioural change program will be used to enhance exercise adoption and adherence to the program. Community-based osteoporosis education seminars will be conducted to improve participant knowledge and understanding of the risk factors and preventative measures for osteoporosis, falls and fractures. The primary outcomes measures, to be collected at baseline, 6, 12, and 18 months, will include DXA-derived hip and spine bone mineral density measurements and functional muscle power (timed stair-climb test). Secondary outcomes measures include: MRI-assessed distal femur and proximal tibia trabecular bone micro-architecture, lower limb and back maximal muscle strength, balance and function (four square step test, functional reach test, timed up-and-go test and 30-second sit-to-stand), falls incidence and health-related quality of life. Cost-effectiveness will also be assessed.

Discussion : The findings from the Osteo-cise: Strong Bones for Life study will provide new information on the efficacy of a targeted multi-modal community-based exercise program incorporating high velocity resistance training, together with an osteoporosis education and behavioural change program for improving multiple risk factors for falls and fracture in older adults at risk of fragility fracture. Trial Registration: Australian New Zealand Clinical Trials Registry reference ACTRN12609000100291

Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures : vital D study

Background Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study.

Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants.

Results Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods.

Conclusion The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected.

Annual high-dose oral vitamin D and falls and fractures in older women : a randomized controlled trial

Context Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor.

Objective To determine whether a single annual dose of 500 000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture.

Design, Setting, and Participants A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008.

Intervention 500 000 IU of cholecalciferol or placebo.

Main Outcome Measures Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels.

Results Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing.

Conclusion Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures.

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.

Severely impacted valgus proximal humeral fractures : surgical technique

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 > or = 160 degrees 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.

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.

Prospective randomized controlled trial comparing dynamic hip screw and screw fixation for undisplaced subcapital hip fractures

Background
Neck of femur fractures (NOFFs) are a common cause of morbidity and mortality in our community. Minimally displaced intracapsular fractures are treated with internal fixation by a two-hole dynamic hip screw (DHS) or three partially threaded cancellous screws. Data to support the superiority of one are limited. This prospective randomized controlled trial compares outcomes with these two fixation methods.

Methods
We prospectively recruited patients over 50 years, with an acute fracture subcapital NOFF, who walked and lived independently, and were cognitively intact. They were randomized into DHS or cancellous screw groups and followed up for 2 years (overall 75.9%). Outcomes of mortality, revision, loss of fixation, avascular necrosis, surgical complications, WOMAC, Harris hip score and SF-12 were measured.

Results
We recruited 62 patients (31 DHS, 29 cancellous screws, 2 failed consent). Six deaths (19.3%) were seen in each group. A total of 3.2% of DHS (1 out of 31) and 10.3% (3 out of 29) of cancellous screw patients required re-operation (P = 0.272). There was no statistical significant difference in patient satisfaction, quality of life (QoL), radiological union or osteonecrosis. There are trends towards better functional scores and QoL in cancellous screws, particularly at 1 year (P = 0.0061), but with a higher re-operation rate. There was a combined mortality and transition to institutional care of 40.0% (24 out of 60) at 2 years.

Conclusions
This study found no difference in outcomes between DHS and cancellous screws in the treatment of subcapital NOFFs in a fit, independent population, but we found a high level of physical decline in previously fit, independently ambulating patients. A large, multicentre trial will be required to differentiate between these two fixation methods.

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).