Treatment of tibial bone defects: pilot analysis of direct medical costs between distraction osteogenesis with an Ilizarov frame and the Masquelet technique.

PURPOSE: The cost implications of limb reconstruction techniques have not been adequately investigated. Aim of this pilot study was to compare the direct medical cost of tibial bone defects managed with distraction osteogenesis-Ilizarov method (ILF), or with Masquelet technique (MIF). METHODS: Data of 20 random patients treated in a single centre were analysed. Inclusion criteria included acute tibial defects, or post-debridement of nonunions with complete follow-up and successful union. The endpoint of clinical efficacy was the time-to-defect union. Comparisons were made between equally sized subgroups (ILF vs. MIF). RESULTS: The average defect length was 5.6 cm (2.6-9.6 cm). The overall cost of 20 cases reached £452,974 (mean £22,339, range £13,459-£36,274). Statistically significant differences favoring the MIF were found regarding the average time-to-union; number of surgeries, of admissions and follow-up visits, as well as the mean intraoperative cost (£8857 vs. £14,087). These differences lead to significant differences of the mean cost of the overall treatment (MIF £18,131 vs. ILF £26,126). Power analysis based on these data indicated that 35 patients on each group would allow detection of a 25% difference, with an alpha value of 0.05 and probability (power) of 0.9. CONCLUSIONS: The results and analysis presented highlight factors affecting the high financial burden, even in a best-case scenario, this type of surgery entails. Larger pivotal studies should follow to improve the cost efficiency of clinical practice.

Can CT-based assessment of lateral malleolus anatomy indicate when and how to perform an intramedullary fixation in distal fibula fractures? An analysis of 150 ankles.

PURPOSE: The primary aim was to analyse the lateral malleolus morphology with a focus on the shape of the distal fibula for IM fixation of the fibula in infra- and transsyndesmotic fracture patterns. The secondary aim was to propose a treatment algorithm according to the lateral malleolar anatomy. METHODS: 77 healthy, skeletally mature volunteers underwent CT scanning of the ankle. The fibula medullary canal and its cortical thickness were quantitatively analysed at 4 different levels measured from the fibular tip (1.5 cm, 3.0 cm, 4.5 cm, and 6.0 cm). A geometric classification was proposed, and a decision algorithm was developed. Statistical significance was set at a p-value < 0.05. RESULTS: The smallest diameter of the medullary canal of the fibula was at 6.0 cm from the tip of the fibula, in 98.2% of the ankles. The distal fibula can be classified into triangular and rectangular type, according to the cortical thickness index (p < 0.0001). In 16.7% ankles, the internal diameter of the fibula at 6.0 cm was equal or narrower than 3.5 mm (p < 0.05). CONCLUSION: The shape of the distal fibula as evaluated by CT-guided analysis allows for IM osteosynthesis of the lateral malleolus in 83% of individuals. In our study, the smallest diameter of the medullary canal of the fibula was located 6.0 cm from the tip of the lateral malleolus. Coronal CT evaluation is advantageous in indicating which type of IM implant should be used safely for infra- and transsyndesmotic fracture patterns, potentially reducing intraoperative risks.

The economic burden of infections following intramedullary nailing for a tibial shaft fracture in England.

OBJECTIVES: Determine the impact of infections on direct costs and healthcare resource use in England for patients undergoing intramedullary nailing (IMN) for tibial shaft fractures. DESIGN: Non-concurrent cohort based on retrospectively collected data with 2-year follow-up. SETTING: England. PARTICIPANTS: The study population included adult patients (≥18 years) in England with a diagnosis of tibial shaft fracture (International Classification of Diseases-10, S822) in the inpatient setting between May 2003 and June 2017 followed by a procedure for IMN for tibial shaft fracture within 30 days. Patient data were derived from the Clinical Practice Research Datalink linked to National Health Service Hospital Episode Statistics datasets. PRIMARY INDEPENDENT VARIABLE: Infection. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was total inpatient costs from index stay admission through 1 year of follow-up. Secondary outcome included cumulative total healthcare costs, and resource utilisation at 30 days, 90 days, 1 year and 2 years. RESULTS: Overall, 805 patients met the inclusion criteria. At index inpatient stay, 3.7% had a post-IMN infection, rising to 11.7% at 1 year. One-year inpatient costs were 80% higher for patients with infection (p<0.001). Total costs were estimated to be £14 756 (95% CI £13 123 to £16 593) for patients with infection versus £8279 (95% CI £7946 to £8626). Length of stay (LOS), readmission and reoperation were the key drivers of healthcare costs (all p<0.001). After adjustment, LOS was higher by 109% (95% CI 62% to 169%), from 10.5 days to 21.9 days, for patients with infection. The odds of being readmitted or requiring reoperation were higher by 5.18 times (95% CI 3.01 to 9.13) and 2.47 times (95% CI 1.48 to 4.09), respectively, for patients with infection versus those without infection. CONCLUSIONS: Post-IMN infection significantly increases inpatient costs, LOS, readmissions and reoperations associated with tibial fracture fixation. Healthcare burden could be reduced through novel surgical site infection prevention strategies.

Dementia and fragility fractures: Issues and solutions.

Dementia and fragility fractures are two conditions that pose significant morbidity and mortality to the elderly population. The occurrence of the 'gerontic' boom as a result of improved healthcare meant a continued increase in the prevalence of fragility fractures and dementia. This represents a major public health problem with significant socioeconomic repercussions. It is therefore important for healthcare professionals to gain a better understanding on the relationship between these two commonly co-existing conditions. In this review, we present the available literature surrounding the relationship between fragility fractures and dementia, and the common challenges faced in the management of these two conditions. Combining evidence from the literature along with our current clinical practice, we propose a management pathway aimed at early diagnosis, prevention and management of these two often co-existing conditions. This alongside with a multidisciplinary approach will not only translate to improved patient outcomes and survivorship, but also reduced healthcare cost and socio-economic burden. To date, there is insufficient evidence from the literature to suggest whether dementia is the cause or effect for fragility fractures, or if indeed there is a bidirectional relationship between the two conditions. Further studies are required to shed light onto this important clinical topic.

Effects of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III open tibia fractures treated with unreamed nails-A clinical and health-economic analysis.

Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) is licensed in Europe for open tibia fractures treated with unreamed nails. However, there is limited data available on the specific use of rhBMP-2 in combination with unreamed nails for open tibia fractures. The intention of the current study was to evaluate the medical and health-economic effects of rhBMP-2 in Gustilo-Anderson grade III open tibia fractures treated with unreamed nails based on individual patient data from two previously published studies. Linear regression analysis was performed on raw data of 90 patients that were either treated by standard of care with soft tissue management and unreamed nailing (SOC group) (n=50) or with rhBMP-2 in addition to soft tissue management and unreamed nailing (rhBMP-2 group) (n=40). For all types of revision, a significant lower percentage of patients (27.5%) of the rhBMP-2 group had to be revised compared to 48% of the patients of the SOC group (p=0.04). When only invasive secondary interventions such as bone grafting and nail exchange were considered, there was also a statistically significant reduction in the rhBMP-2 group with a revision rate of 10.0% (4 of 40 patients) compared to the SOC group with a revision rate of 28.0% (14 of 50 patients) (p=0.01). Mean fracture healing time of 228 days in the rhBMP-2 compared to 266 days in the SOC group was not statistically significant (p=0.24). Health-economic analysis based on a societal perspective with calculation of overall treatment costs after initial surgery and including productivity losses revealed savings of €6,239 per patient for Germany and €4,752 for the UK in favour of rhBMP-2 which was mainly driven by reduction of productivity losses. In conclusion, rhBMP-2 reduces secondary interventions in patients with grade III open tibia fractures treated with an unreamed nail and its use leads to financial savings for Germany and the UK from a societal perspective.

Cost analysis and outcomes of simple elbow dislocations.

AIM: To evaluate the management, clinical outcome and cost implications of three different treatment regimes for simple elbow dislocations. METHODS: Following institutional board approval, we performed a retrospective review of all consecutive patients treated for simple elbow dislocations in a Level I trauma centre between January 2008 and December 2010. Based on the length of elbow immobilisation (LOI), patients were divided in three groups (Group I, < 2 wk; Group II, 2-3 wk; and Group III, > 3 wk). Outcome was considered satisfactory when a patient could achieve a pain-free range of motion ≥ 100° (from 30° to 130°). The associated direct medical costs for the treatment of each patient were then calculated and analysed. RESULTS: We identified 80 patients who met the inclusion criteria. Due to loss to follow up, 13 patients were excluded from further analysis, leaving 67 patients for the final analysis. The mean LOI was 14 d (median 15 d; range 3-43 d) with a mean duration of hospital engagement of 67 d (median 57 d; range 10-351 d). Group III (prolonged immobilisation) had a statistically significant worse outcome in comparison to Group I and II (P = 0.04 and P = 0.01 respectively); however, there was no significant difference in the outcome between groups I and II (P = 0.30). No statistically significant difference in the direct medical costs between the groups was identified. CONCLUSION: The length of elbow immobilization doesn't influence the medical cost; however immobilisation longer than three weeks is associated with persistent stiffness and a less satisfactory clinical outcome.

Surgical management of infected non-unions: An update.

Infected non-union is a devastating complication post fracture fixation. While its incidence is small, its management is lengthy, challenging and costly. Complex reconstruction surgery is often required with unpredictable outcomes despite the significant advances that have been made in diagnostics, surgical techniques and antibiotic protocols. In this article we present recent approaches to the surgical treatment of this condition.

Assessment of umbilical cord tissue as a source of mesenchymal stem cell/endothelial cell mixtures for bone regeneration.

AIM: To enumerate and characterize mesenchymal stem cells (MSCs) and endothelial cells (ECs) in umbilical cord (UC) tissue digests. MATERIALS & METHODS: Cultured UC cells were characterized phenotypically, and functionally by using 48-gene arrays. Native MSCs and ECs were enumerated using flow cytometry. RESULTS: Compared with bone marrow (BM) MSCs, UC MSCs displayed significantly lower (range 4-240-fold) basal levels of bone-related transcripts, but their phenotypes were similar (CD73⁺, CD105⁺, CD90⁺, CD45⁻ and CD31⁻). UC MSCs responded well to osteogenic induction, but day 21 postinduction levels remained below those achieved by BM MSCs. The total yield of native UC MSCs (CD90⁺, CD45⁻ and CD235α⁻) and ECs (CD31⁺, CD45⁻ and CD235α⁻) exceeded 150 and 15 million cells/donation, respectively. Both UC MSCs and ECs expressed CD146. CONCLUSION: While BM MSCs are more predisposed to osteogenesis, UC tissue harbors large numbers of MSCs and ECs; such minimally manipulated 'off-the-shelf' cellular mixtures can be used for regenerating bone in patients with compromised vascular supply.

Assessment of Lateral Compression type 1 pelvic ring injuries by intraoperative manipulation: which fracture pattern is unstable?

PURPOSE: We performed a prospective study to document, by intra-operative manipulation under anaesthesia (MUA) of the pelvic ring, the stability of lateral compression type 1 injuries that were managed in a Level-I Trauma Centre. The documentation of the short-term outcome of the management of these injuries was our secondary aim. METHODS: A total of 63 patients were included in the study. Thirty-five patients (group A) were treated surgically whereas 28 (group B) were managed nonoperatively. Intraoperative rotational instability, evident by more than two centimetres of translation during the manipulation manoeuvre, was combined with a complete sacral fracture in all cases. RESULTS: A statistically significant difference was present between the length of hospital stay, the time to independent pain-free mobilisation, post-manipulation pain levels and opioid requirements between the two groups, with group A demonstrating significantly decreased values in all these four variables (p < 0.05). There was also a significant difference between the pre- and 72-hour post-manipulation visual analogue scale and analgesic requirements of the group A patients, whereas the patients in group B did not demonstrate such a difference. CONCLUSION: LC-1 injuries with a complete posterior sacral injury are inheritably rotationally unstable and patients presenting with these fracture patterns definitely gain benefit from surgical stabilisation.

What is the role of the orthopaedic surgeon in management of fragility fractures?

Fragility fractures are the most prevalent trauma condition that orthopaedic surgeons face today. Osteoporosis and susceptibility to falls are the key predisposing factors. Despite evidence supporting the impact of treating osteoporosis on reducing the incidence of fragility fractures, it is often left untreated. Orthopaedic surgeons are often the first physicians to assess and treat the patient after a fragility fracture. Their role therefore does not end in the skillful fixation of the fractures, but they have a unique opportunity to ensure that preventive measures are implemented. This includes falls prevention, investigation of possible causes underlying osteoporosis, attention to diet, exercise, calcium, and vitamin D supplementation as well as prescription of anti-resorptive and anabolic medication. The need for a dedicated multidisciplinary team needs to be emphasized and therefore effective communication between the different parties is of paramount importance.

The role and efficacy of denosumab in the treatment of osteoporosis: an update.

INTRODUCTION: Bone strength determinants such as bone mineral density and bone quality parameters are determined by life-long remodeling of skeletal tissue. Denosumab is a fully human mAb receptor activator of NF-κB ligand, which selectively inhibits osteoclastogenesis, the end product of a cascade interaction among numerous systemic and local factors and osteoblasts. It has been approved for clinical use by the FDA in the US and by the European Medicines Agency in Europe since June 2010 (trade name Prolia(™), Amgen, Thousand Oaks, CA, USA). AREAS COVERED: This review establishes the concerns and provides insights in issues concerning the cost-effectiveness and safety profile of this new pharmaceutical agent. There is an effort to clarify the special characteristics and the anti-catabolic role of denosumab in the bone tissue homeostasis and more specifically its potential clinical applications and clinical results in the field of postmenopausal osteoporosis. EXPERT OPINION: Administrated as a subcutaneous injection every 6 months, denosumab has been shown to decrease bone turnover and increase bone mineral density in postmenopausal women with low bone mass or osteoporosis and reduce vertebral, hip and nonvertebral fracture risk in postmenopausal women with osteoporosis. The rapid, sustained and reversible effect in suppressing osteoclastic bone resorption, the return of responsiveness on rechallenge, its good tolerability and ease of administration are features that distinguish it from other antiresorptive therapies.

Damage control orthopaedics: lessons learned.

Damage control orthopaedics (DCO) is a staged approach for the management of multiply injured patients. It is ideal for trauma patients presenting in an unstable or extremis physiological state. It focuses on the rapid resuscitation of these patients by providing temporary stabilisation of fractures while at the same time reducing the biological load of surgery. Early findings support its usefulness in controlling the lethal triad of hypothermia, acidosis and coagulopathy. Furthermore, recent evidence indicates that it regulates the evolving systemic inflammatory response, reducing the detrimental complications of adult respiratory distress syndrome, multiple organ dysfunction and subsequent mortality. Although DCO has been proven a useful surgical strategy for efficiently managing patients with multiple trauma, further work is required to establish fully its indications, results and cost implications.

Fondaparinux for the prevention or treatment of venous thromboembolism related to lower limb trauma: evidence today.

Patients with lower limb and pelvic trauma, or undergoing major orthopaedic surgery represent one of the highest risk groups for the development of venous thromboembolism (VTE). A significant number of pharmacological and mechanical agents have been used for the prophylaxis and treatment of VTE. Fondaparinux is a relative new pharmacological agent that selectively binds to antithrombin, and represents a new class of synthetic selective inhibitors of activated factor X. Eleven percent of the fondaparinux-related English language literature, between 2001 and 2007, refers to orthopaedic trauma, and was the sample assessed for this critical analysis review. The clinical studies evaluating the safety, efficacy, and financial implications associated with lower limb orthopaedic trauma show that fondaparinux has comparable results with the well-established use of enoxaparin. However, the scientific community has raised several issues regarding mostly fondaparinux's safety, timing of its 1(st) dose, bleeding side effects, duration of administration and lack of a reliable reversing agent. Further trials are necessary focusing on the safety and efficacy of this drug mostly in relation to clinical relevant outcomes and to different fields of trauma surgery (pelvis, long bone fractures and polytrauma patients).

The health economics of the treatment of long-bone non-unions.

A review of the existing evidence on economic costs of treatment of long-bone fracture non-unions has retrieved 9 papers. Mostly the tibial shaft non-unions have been utilised as models for these economic analyses. Novel treatment strategies like BMP-7 grafting, Ilizarov ring external fixation or supplementary use of therapeutic ultrasound devices have been compared with standard methods of treatment focusing on direct and indirect costs and expenses. A cost-identification query was conducted and revealed costs of pound 15,566, pound 17,200 and pound 16,330 for humeral, femoral, and tibial non-unions respectively on a "best-case scenario". The existing scientific evidence can only imply the extent of the economic burden of long-bone non-unions. Further systematic studies are needed to assess the direct medical, direct non-medical, indirect, and monetised quality of life and psychosocial costs of non-unions.

Pelvic and acetabular surgery within Europe: the need for the co-ordination of treatment concepts.

Pelvic and acetabular injuries are rare and represent the tip of the trauma iceberg. They often present with other associated injuries. Their management can pose difficulties even to the most experienced trauma surgeons and well-developed trauma systems. Despite the advancements made after the 1960s due to Judet and Letournel's contributions, the pelvic and acetabular sub-specialty has had difficulty in consolidating experience and developing realistic treatment protocols. By means of sharing ideas and results, "learning curves" of individuals and nations could be shortened. As a result, better health quality and advanced medical facilities for our future patients may be anticipated. In this article we examine the current problems affecting the provision of a high quality pelvic and acetabular service and analyse the needs for the co-ordination of treatment concepts within the European Landscape.

Health economics: a cost analysis of treatment of persistent fracture non-unions using bone morphogenetic protein-7.

OBJECTIVE: To compare the cost implications of treatment of persistent fracture non-unions before and after application of recombinant human bone morphogenetic protein-7 (BMP-7). METHOD: Of 25 fracture non-unions, 9 were treated using BMP-7 alone and 16 using BMP-7 and bone grafting. These patients were prospectively followed up, and the costs incurred were analysed. RESULTS: The mean number of procedures per fracture performed before application of BMP-7 was 4.16, versus 1.2 thereafter. Mean hospital stay and cost of treatment per fracture before receiving BMP-7 were 26.84 days and pound 13,844.68, versus 7.8 days and pound 7338.4 thereafter. The overall cost of treatment of persistent fracture non-unions with BMP-7 was 47.0% less than that of the numerous previous unsuccessful treatments (p=0.001). CONCLUSIONS: Treating fracture non-unions is costly, but this could be reduced by early BMP-7 administration when a complex or persistent fracture non-union is present or anticipated.