The Compress® transcutaneous implant for rehabilitation following limb amputation.

Amputation is an unfortunate outcome of a variety of orthopedic conditions. Many amputees can be functionally fitted with conventional suspension sockets. A substantial subset, however, fails this conventional treatment and is unable to function. In Europe, an alternative to socket-based prostheses has been available for 25 years. Patients there who are unable to functionally use socket-based prostheses have been offered the possibility for transcutaneous osseointegration. With this technology, the prosthetic limb can be rigidly attached to the residual bone, and the socket is eliminated, in many cases enabling improved function and patient satisfaction. In the United States, regulatory barriers have greatly limited the adoption and acceptance of transdermal osseointegration. The Compress® device was developed as an alternate means of fixation for massive endoprostheses, such as distal femoral replacements. A uniquely designed prosthesis is rigidly anchored to the end of the cortical bone and is then subjected to a large axial stress. The bone then grows avidly into the device, providing permanent osseointegration. We have recently adopted this device for transcutaneous use. These procedures have been performed in the United States on a custom regulatory basis. Results of this have been encouraging, and we are planning to begin a regulatory trial in the near future.

Effectiveness of foot fasciotomies in foot and ankle trauma.

BACKGROUND: Foot compartment syndrome (FCS) has been reported to cause neuropathic pain, claw or hammer toes, and motor and sensory disturbances. The optimal treatment of FCS is controversial. The purpose of this study was to determine if foot fasciotomies improve patient outcomes in high-energy, combat-related lower extremity trauma. METHODS: Medical records of patients with documented FCS from May 2007 to January 2009 were retrospectively reviewed. Consecutive, matched control patients were identified based on similar hindfoot, mid-foot and/or forefoot injuries who did not undergo foot fasciotomy during the same period. The primary outcomes analysed were the development of claw or hammer toes and neuropathic pain. RESULTS: 19 patients with foot fasctiotomies were identified and matched with 19 controls. Median follow-up was 19.5 months (range, 3.5-47.5 months) for the combined cohorts. The most common mechanism of injury was an explosive blast. Nine fasciotomy and nine control patients sustained open foot fractures. Significantly more patients with foot fasciotomies developed claw toes (50% vs 17%, p=0.03). There were no significant differences in the development of neuropathic pain, sensory deficits, motor deficits, chronic pain, stiffness or infection. The fasciotomy patients underwent an average of 5.5 surgeries per patient versus 4 surgeries per patient in the control group. CONCLUSIONS: Fasciotomy of the foot did not prevent neuropathic pain and deformities in patients with FCS in this study.

Public attitudes towards genomic risk profiling as a component of routine population screening.

Including low penetrance genomic variants in population-based screening might enable personalization of screening intensity and follow up. The application of genomics in this way requires formal evaluation. Even if clinically beneficial, uptake would still depend on the attitudes of target populations. We developed a deliberative workshop on two hypothetical applications (in colorectal cancer and newborn screening) in which we applied stepped, neutrally-framed, information sets. Data were collected using nonparticipant observation, free-text comments by individual participants, and a structured survey. Qualitative data were transcribed and analyzed using thematic content analysis. Eight workshops were conducted with 170 individuals (120 colorectal cancer screening and 50 newborn screening for type 1 diabetes). The use of information sets promoted informed deliberation. In both contexts, attitudes appeared to be heavily informed by assessments of the likely validity of the test results and its personal and health care utility. Perceived benefits included the potential for early intervention, prevention, and closer monitoring while concerns related to costs, education needs regarding the probabilistic nature of risk, the potential for worry, and control of access to personal genomic information. Differences between the colorectal cancer and newborn screening groups appeared to reflect different assessments of potential personal utility, particularly regarding prevention.

Link Between Clinical Predictors of Heterotopic Ossification and Histological Analysis in Combat-Injured Service Members.

BACKGROUND: Heterotopic ossification (HO) is a debilitating condition that occurs following traumatic injury and may restrict range of motion and delay rehabilitation. The timing and efficacy of surgical resection have varied widely, and there is a gap in knowledge between clinical predictors of HO recurrence and histological analysis. METHODS: Thirty-three service members seen at Walter Reed National Military Medical Center for symptomatic HO were enrolled in an institutional review board-approved study. Participants took oxytetracycline on four scheduled days prior to HO resection to determine the mineral apposition rate (bone growth rate). RESULTS: Detailed histological analyses included scanning electron microscopy with backscattered electron imaging and light microscopy. Data indicated that the mineral apposition rate of trauma-induced HO was approximately 1.7 µm/day at the time of operative intervention, which was 1.7 times higher than the rate in non-pathological human bone. The mineral apposition rate and postoperative alkaline phosphatase values were demonstrated to be positively and significantly related (ρ = 0.509, p = 0.026, n = 19). When the analysis was limited to patients with no more than a two-year period from injury to excision (thereby removing outliers who had a longer time period than their counterparts) and traumatic brain injury and nonsteroidal anti-inflammatory drugs (known correlates with HO development) were controlled for in the statistical analysis, the mineral apposition rate and recurrence severity were significantly related (ρ = -0.572, p = 0.041, n = 11). CONCLUSIONS: Data demonstrated a link between benchtop research and bedside care, with the mineral apposition rate elevated in patients with HO and correlated with recurrence severity; however, a larger sample size and more clinical factors are needed to refine this model. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

The development of a rat model to investigate the formation of blast-related post-traumatic heterotopic ossification.

Currently, there is no animal model in which to evaluate the underlying physiological processes leading to the heterotopic ossification (HO) which forms in most combat-related and blast wounds. We sought to reproduce the ossification that forms under these circumstances in a rat by emulating patterns of injury seen in patients with severe injuries resulting from blasts. We investigated whether exposure to blast overpressure increased the prevalence of HO after transfemoral amputation performed within the zone of injury. We exposed rats to a blast overpressure alone (BOP-CTL), crush injury and femoral fracture followed by amputation through the zone of injury (AMP-CTL) or a combination of these (BOP-AMP). The presence of HO was evaluated using radiographs, micro-CT and histology. HO developed in none of nine BOP-CTL, six of nine AMP-CTL, and in all 20 BOP-AMP rats. Exposure to blast overpressure increased the prevalence of HO. This model may thus be used to elucidate cellular and molecular pathways of HO, the effect of varying intensities of blast overpressure, and to evaluate new means of prophylaxis and treatment of heterotopic ossification.

Stakeholder attitudes towards the role and application of informed consent for newborn bloodspot screening: a study protocol.

INTRODUCTION: Newborn bloodspot screening (NBS) involves testing a small sample of blood taken from the heel of the newborn for a number of serious and life-limiting conditions. In Canada, newborn screening programmes fall under provincial and territorial jurisdiction with no federal coordination. To date, we know very little about the underlying beliefs around different consent practices or how terminology is interpreted by different individuals. Differences in attitudes may have important healthcare consequences. This study will provide empirical data comparing stakeholder opinions on their understanding of consent-related terminology, the perceived applicability of different consent approaches to newborn screening, and the requirements of these different approaches. METHODS AND ANALYSIS: Parents, healthcare professionals and policymakers will be recruited in the provinces of Ontario and Newfoundland and Labrador. Parents will be identified through records held by each provincial screening programme. Healthcare professionals will be purposively sampled on the basis of engagement with newborn screening. Within each province we will identify policymakers who have policy analysis or advisory responsibilities relating to NBS. Data collection will be by qualitative interviews. We will conduct 20 interviews with parents of young children, 10 interviews with key healthcare professionals across the range of appropriate specialties and 10 with policymakers at each site (40 per site, total, N=80). The examination of the transcripts will follow a thematic analysis approach. Recruitment started in June 2014 and is expected to be complete by June 2015. ETHICS AND DISSEMINATION: This study received ethics approval from the Ottawa Health Science Network Research Ethics Board, the Children's Hospital of Eastern Ontario Research Ethics Board (both Ontario), and the Health Research Ethics Authority (Newfoundland and Labrador). RESULTS: These will be reported in peer-reviewed publications and conference presentations. The results will have specific application to the development of parent education materials for newborn screening.

Blast injuries and heterotopic ossification.

Heterotopic ossification (HO) is perhaps the single most significant obstacle to independence, functional mobility, and return to duty for combat-injured veterans of Operation Enduring Freedom and Operation Iraqi Freedom. Recent research into the cause(s) of HO has been driven by a markedly higher prevalence seen in these wounded warriors than encountered in previous wars or following civilian trauma. To that end, research in both civilian and military laboratories continues to shed light onto the complex mechanisms behind HO formation, including systemic and wound specific factors, cell lineage, and neurogenic inflammation. Of particular interest, non-invasive in vivo testing using Raman spectroscopy may become a feasible modality for early detection, and a wound-specific model designed to detect the early gene transcript signatures associated with HO is being tested. Through a combined effort, the goals of early detection, risk stratification, and development of novel systemic and local prophylaxis may soon be attainable.

Family history tools in primary care: does one size fit all?

Family health history (FHH) has potential value in many health care settings. This review discusses the potential uses of FHH information in primary care and the need for tools to be designed accordingly. We developed a framework in which the attributes of FHH tools are mapped against these different purposes. It contains 7 attributes mapped against 5 purposes. In considering different FHH tool purposes, it is apparent that different attributes become more or less important, and that tools for different purposes require different implementation and evaluation strategies. The context in which a tool is used is also relevant to its effectiveness. For FHH tools, it is unlikely that 'one size fits all', although appreciation of different purposes, users and contexts should facilitate the development of different applications from single FHH platforms.

Ethical, legal, and social issues in health technology assessment for prenatal/preconceptional and newborn screening: a workshop report.

Prenatal/preconceptional and newborn screening programs have been a focus of recent policy debates that have included attention to ethical, legal, and social issues (ELSIs). In parallel, there has been an ongoing discussion about whether and how ELSIs may be addressed in health technology assessment (HTA). We conducted a knowledge synthesis study to explore both guidance and current practice regarding the consideration of ELSIs in HTA for prenatal/preconceptional and newborn screening. As the concluding activity for this project, we held a Canadian workshop to discuss the issues with a diverse group of stakeholders. Based on key workshop themes integrated with our study results, we suggest that population-based genetic screening programs may present particular types of ELSIs and that a public health ethics perspective is potentially highly relevant when considering them. We also suggest that approaches to addressing ELSIs in HTA for prenatal/preconceptional and newborn screening may need to be flexible enough to respond to diversity in HTA organizations, cultural values, stakeholder communities, and contextual factors. Finally, we highlight a need for transparency in the way that HTA producers move from evidence to conclusions and the ways in which screening policy decisions are made.