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).

Physical interpretation of the reference features in textural fractography of fatigue fractures

Reference features of a fatigue fracture surface are the reference texture and reference crack growth rate which are unambiguously mutually related. The reference texture is a subset of the image texture in SEM fractographs. It is expected to be common to all fractures caused by loadings in which significant events occur sufficiently regularly and frequently. The ratio of the reference and the conventional crack growth rate called reference factor is a characteristic of a particular loading. Its value may be related to the sequence of successive sizes of the cyclic plastic zone, while the mechanism of the effect of overloads follows the models of Wheeler and Willenborg. Application to a set of nine test specimens from aluminium alloy loaded by three different loading regimes is shown.

Interobserver reliability of classification and characterization of proximal humeral fractures: a comparison of two and three-dimensional CT

Interobserver reliability for the classification of proximal humeral fractures is limited. The aim of this study was to test the null hypothesis that interobserver reliability of the AO classification of proximal humeral fractures, the preferred treatment, and fracture characteristics is the same for two-dimensional (2-D) and three-dimensional (3-D) computed tomography (CT). Members of the Science of Variation Group--fully trained practicing orthopaedic and trauma surgeons from around the world--were randomized to evaluate radiographs and either 2-D CT or 3-D CT images of fifteen proximal humeral fractures via a web-based survey and respond to the following four questions: (1) Is the greater tuberosity displaced? (2) Is the humeral head split? (3) Is the arterial supply compromised? (4) Is the glenohumeral joint dislocated? They also classified the fracture according to the AO system and indicated their preferred treatment of the fracture (operative or nonoperative). Agreement among observers was assessed with use of the multirater kappa (κ) measure. Interobserver reliability of the AO classification, fracture characteristics, and preferred treatment generally ranged from "slight" to "fair." A few small but statistically significant differences were found. Observers randomized to the 2-D CT group had slightly but significantly better agreement on displacement of the greater tuberosity (κ = 0.35 compared with 0.30, p < 0.001) and on the AO classification (κ = 0.18 compared with 0.17, p = 0.018). A subgroup analysis of the AO classification results revealed that shoulder and elbow surgeons, orthopaedic trauma surgeons, and surgeons in the United States had slightly greater reliability on 2-D CT, whereas surgeons in practice for ten years or less and surgeons from other subspecialties had slightly greater reliability on 3-D CT. Proximal humeral fracture classifications may be helpful conceptually, but they have poor interobserver reliability even when 3-D rather than 2-D CT is utilized. This may contribute to the similarly poor interobserver reliability that was observed for selection of the treatment for proximal humeral fractures. The lack of a reliable classification confounds efforts to compare the outcomes of treatment methods among different clinical trials and reports.

Physical activity and exercise in the maintenance of the adult skeleton and the prevention of osteoporotic fractures

In the prevention of osteoporosis and osteoporoticrelated fractures, strategies aimed at maximizing peak bone mass during childhood and adolescence; maintaining or attenuating bone loss during the adult years; and increasing or preserving muscle mass, strength, power, and function are all considered critical. To this end, physical activity and exercise are recognized as important modifiable lifestyle variables that can strengthen the skeleton and muscles and reduce the risk of falls and subsequent fracture, as well as enhance quality of life...