Early mobilization versus plaster immobilization of simple elbow dislocations: a cost analysis of the FuncSiE multicenter randomized clinical trial.

INTRODUCTION: The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization in patients with a simple elbow dislocation. It was hypothesized that early mobilization would not lead to higher direct and indirect costs. MATERIALS AND METHODS: This study used data of a multicenter randomized clinical trial (FuncSiE trial). From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation were recruited and randomized to early mobilization (immediate motion exercises; n = 48) or 3 weeks plaster immobilization (n = 52). Patients completed questionnaires on health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence. Follow-up was 1 year. Primary outcome were the total costs at 1 year. Analysis was by intention to treat. RESULTS: There were no significant differences in EQ-5D, SF-36 PCS, and SF-36 MCS between the two groups. Mean total costs per patient were €3624 in the early mobilization group versus €7072 in the plaster group (p = 0.094). Shorter work absenteeism in the early mobilization group (10 versus 18 days; p = 0.027) did not lead to significantly lower costs for loss of productivity (€1719 in the early mobilization group versus €4589; p = 0.120). CONCLUSION: From a clinical and a socio-economic point of view, early mobilization should be the treatment of choice for a simple elbow dislocation. Plaster immobilization has inferior results at almost double the cost.

Cost-effective trauma implant selection: AAOS exhibit selection.

Today's increasingly complex health-care landscape requires that physicians take an active role in minimizing health-care costs and expenditures. Judicious choice of implants, a fracture-driven treatment algorithm, capitation models, use of generic fracture implants, and reuse of external fixation constructs all represent mechanisms that can result in substantial savings. In some health-care environments, these cost savings programs may be directly linked to physician reimbursement in the form of gainsharing plans. Evidence-based critical evaluations of implant usage patterns are necessary to help control implant-related health-care spending but are lacking in the current literature. Physicians need to acknowledge their influence and responsibility in this realm and assume an active role to help reduce costs.

The MAGEC system for spinal lengthening in children with scoliosis: A NICE Medical Technology Guidance.

Scoliosis-structural lateral curvature of the spine-affects around four children per 1,000. The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller, which lengthens the rod; this system avoids repeated surgical lengthening. Rod implants brace the spine internally and are lengthened as the child grows, preventing worsening of scoliosis and delaying the need for spinal fusion. The Medical Technologies Advisory Committee at the National Institute for Health and Care Excellence (NICE) selected the MAGEC system for evaluation in a NICE medical technologies guidance. Six studies were identified by the sponsor (Ellipse Technologies Inc.) as being relevant to the decision problem. Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded. The key weakness was selection of a single comparator study. The External Assessment Centre (EAC) identified 16 conventional growth rod studies and undertook meta-analyses of relevant outcomes. Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions. The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods. The EAC critiqued and updated the model structure and inputs, calculating robust cost savings of £12,077 per patient with MAGEC rods compared with conventional rods over 6 years. The year of valuation was 2012. NICE issued a positive recommendation as supported by the evidence (Medical Technologies Guidance 18).

From disclosure to transparency: the use of company payment data.

BACKGROUND: It has become standard practice in medical journals to require authors to disclose their relationships with industry. However, these requirements vary among journals and often lack specificity. As a result, disclosures may not consistently reveal author-industry ties. METHODS: We examined the 2007 physician payment information from 5 orthopedic device companies to evaluate the current journal disclosure system. We compared company payment information for recipients of $1 million or more with disclosures in the recipients' journal articles. Payment data were obtained from Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. Disclosures were obtained in the acknowledgments section, conflict of interest statements, and financial disclosures of recipients' published articles. We also assessed variations in disclosure by authorship position, payment-article relatedness, and journal disclosure policies. RESULTS: Of the 41 individuals who received $1 million or more in 2007, 32 had published articles relating to orthopedics between January 1, 2008, and January 15, 2009. Disclosures of company payments varied considerably. Prominent authorship position and article-payment relatedness were associated with greater disclosure, although nondisclosure rates remained high (46% among first-, sole-, and senior-authored articles and 50% among articles directly or indirectly related to payments). The accuracy of disclosures did not vary with the strength of journals' disclosure policies. CONCLUSIONS: Current journal disclosure practices do not yield complete or consistent information regarding authors' industry ties. Medical journals, along with other medical institutions, should consider new strategies to facilitate accurate and complete transparency.

Is surgery for displaced, midshaft clavicle fractures in adults cost-effective? Results based on a multicenter randomized, controlled trial.

OBJECTIVES: To determine the cost-effectiveness of open reduction internal fixation (ORIF) of displaced, midshaft clavicle fractures in adults. DESIGN: Formal cost-effectiveness analysis based on a prospective, randomized, controlled trial. SETTING: Eight hospitals in Canada (seven university-affiliated and one community hospital). PATIENTS/PARTICIPANTS: One hundred thirty-two adults with acute, completely displaced, midshaft clavicle fractures. INTERVENTION: Clavicle ORIF versus nonoperative treatment. MAIN OUTCOME MEASUREMENTS: Utilities derived from SF-6D. RESULTS: The base case cost per quality-adjusted life-year (QALY) gained for ORIF was $65,000. Cost-effectiveness improved to $28,150/QALY gained when the functional benefit from ORIF was assumed to be permanent with cost per QALY gained falling below $50,000 when the functional advantage persisted for 9.3 years or more. In other sensitivity analyses, the cost per QALY gained for ORIF fell below $50,000 when ORIF cost less than $10,465 (base case cost $13,668) or the long-term utility difference between nonoperative treatment and ORIF was greater than 0.034 (base case difference 0.014). Short-term disutility associated with fracture healing also affected cost-effectiveness with the cost per QALY gained for ORIF falling below $50,000 when the utility of a fracture treated nonoperatively before union was less than 0.617 (base case utility 0.706) or when nonoperative treatment increased the time to union by 20 weeks (base case difference 12 weeks). CONCLUSIONS: The cost-effectiveness of ORIF after acute clavicle fracture depended on the durability of functional advantage for ORIF compared with nonoperative treatment. When functional benefits persisted for more than 9 years, ORIF had a favorable value compared with many accepted health interventions.

Health-economic evaluation in implant trials: design considerations.

In today's world, demonstration of the safety, efficacy, and quality of a new treatment strategy is no longer sufficient in many countries for market entry and reimbursement in the public healthcare system. This implies that new implants in orthopedic and orthopedic trauma surgery not only must be shown to lead to better medical outcome compared with the standard of care implant, but also must be shown to exhibit "good value" for the money for the public health-care system based on sound economic data from health-economic studies. The purpose of this article is to elucidate a framework for health-economic aspects alongside implant trials, with the assumption that the new implant is more costly but potentially better than the control implant. Cost-effectiveness, cost-utility, and cost-benefit studies are suitable for the assessment of the health-economic value of a new implant. The following criteria should be considered for a health-economic study design in the context with an implant: i) it should state medical benefits of the new implant compared with the control implant; ii) it should precise the type of health economic study; iii) it should define the methodological approach, perspective of the study, and types of costs; iv) if necessary, it should state discount costs and/benefits; and v) a sound sensitivity analysis should be included. Furthermore, close cooperation between researchers, clinicians, and health economists is essential.

The dynamic vacuum orthosis: a functional and economical benefit?

In a prospective, randomised study, 27 patients with internally fixed ankle fractures were treated post-operatively for a period of six weeks by application of either a new dynamic vacuum orthosis with permitted mobilisation to 10 degrees -0 degrees -10 degrees at the ankle joint or a synthetic cast. Full weight bearing was allowed in both groups after two weeks. The cast group was prescribed four weeks of physiotherapy following six weeks of immobilisation. After ten weeks, the Olerud and Molander score showed a significant difference in favour of the orthosis. Early functional outcomes were significantly better for this group after six weeks and ten weeks. Patients in the orthosis group who were in formal employment returned to work 24 days earlier than those in the control group. Treatment of the orthosis patients took up three to four times less working time for the medical personnel. A saving of 38 euros on directly ascertainable costs could be evaluated. Rehabilitation of ankle fractures with a dynamic vacuum orthosis leads to better early functional results and greater patient satisfaction. The orthosis fulfils the conditions for early return to work. Treatment with an orthosis not only reduces working time for medical personnel but economises on expenditure for treatment and rehabilitation.

Surgical revision rates of hooks versus hybrid versus screws versus combined anteroposterior spinal fusion for adolescent idiopathic scoliosis.

STUDY DESIGN: Multi-institution retrospective review. OBJECTIVE: To determine the surgical revision rates of hook, hybrid, anteroposterior, and total pedicle screw constructs for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Much debate continues on the safety, efficacy, and cost of thoracic pedicle screws. Nonetheless, there are no large series that have evaluated the revision rate of various constructs in AIS to determine the need for repeat surgery, and therefore, the added indirect costs and risks of additional procedures. METHODS: We retrospectively reviewed the surgical case logs of 1428 patients with AIS at 2 institutions from 1990 to 2004, and the clinical records and radiographs of revision cases. Patients were classified into 1 of 4 groups: hook, hybrid hook and screw, all pedicle screw, and combined anteroposterior fusion constructs. Overall, there were 65 (4.6%) returns to the operating room, or 55 (3.9%) cases after excluding infections without concomitant pseudarthrosis. RESULTS: Of the 65 revision cases, there were 52 females and 13 males, at an average age at first surgery of 13.9 years (range, 9-18 years), and an average age at revision of 14.7 years (range, 12-23 years). For the revision cases, the average initial Cobb was 61.9 degrees (range 44 degrees -110 degrees ), and this was not statistically different within the cohorts (P > 0.05). In terms of revision rate, all hook constructs had a higher revision rate secondary to instrumentation failure when compared with screws, while both hook and hybrid constructs had an overall higher surgical revision rate when compared with screw constructs or anteroposterior constructs (all P

ISSLS prize winner: cost-effectiveness of two forms of circumferential lumbar fusion: a prospective randomized controlled trial.

STUDY DESIGN: Economic evaluation alongside a prospective, randomized controlled trial from a secondary care National Health Service (NHS) perspective. OBJECTIVE: To determine the cost-effectiveness of titanium cages (TC) compared with femoral ring allografts (FRA) in circumferential lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: A randomized controlled trial has shown the use of TC to be clinically inferior to the established practice of using FRA in circumferential lumbar fusion. Health economic evaluation is urgently needed to justify the continued use of TC, given that this treatment is less effective and, all things being equal, is assumed more costly than FRA. METHODS: Eighty-three patients were randomly allocated to receive either the TC or FRA as part of a circumferential lumbar fusion between 1998 and 2002. NHS costs related to the surgery and revision surgery needed during the trial period were monitored and adjusted to the base year (2005-2006 Pounds Sterling). The Short Form-6D (SF-6D) was administered before surgery and at 6, 12 and 24 months in order to elicit patient utility and subsequently Quality-Adjusted Life Years (QALYs) for the trial period. Return to paid employment was also monitored. Bootstrapped mean differences in discounted costs and benefits were generated in order to explore cost-effectiveness. RESULTS: A significant cost difference of pound 1950 (95% CI, pound 849 to pound 3145) in favor of FRA was found. Mean QALYs per patient over the 24-month trial period were 0.0522 (SD, 0.0326) in the TC group and 0.1914 (SD, 0.0398) in the FRA group, producing a significant difference of -0.1392 (95% CI, -0.2349 to -0.0436). With regard to employment, incremental productivity costs were estimated at pound 185,171 in favor of FRA. CONCLUSION: From an NHS perspective, the trial data show that TC is not cost-effective in circumferential lumbar fusion. The use of FRA was both cheaper and generated greater QALY gains. In addition, FRA patients reported a greater return to work rate.

Uso de tornillos transpediculares en el tratamiento de la inestabilidad espinal / Treatment with transpedicular screws for spinal instability

Los tornillos transpediculares han sido usados clínicamente de una manera amplia en los últimos 20 años y han llegado a ser el método estándar para la fijación posterolateral y fusión de la columna dorsal, lumbar y sacra. En nuestro medio el uso de ese tipo de instrumentación es muy limitado debido a la poca disponibilidad de estos sistemas en el mercado local y al costo de los mismos. En manos de cirujanos espinales entrenados y experimentados este sistema tiene una elevada tasa de seguridad, efectividad y menor número de complicaciones que cualquiera de los otros sistemas de instrumentación disponibles en nuestro medio. Presentamos los resultados preliminares del primer estudio prospectivo en nuestro país sobre este tipo de instrumentación en 33 pacientes sometidos a fijación espinal con tornillos transpediculares, haciendo también una revisión bibliográfica del tema, exponemos nuestras experiencias y los resultados obtenidos.CONCLUSION: El sistema transpedicular puede ser usado de forma confiable tanto en trauma como en patología degenerativa de la columna dorsal y lumbosacra. La fijación nos permite conseguir una remisión de dolor espinal en el 100% de los casos, una buena tasa de fusión ósea, mínimas complicaciones y reicorporación temprana de los pacientes a sus actividades...

Uso de tornillos transpediculares en el tratamiento de la inestabilidad espinal / Treatment with transpedicular screws for spinal instability

Los tornillos transpediculares han sido usados clínicamente de una manera amplia en los últimos 20 años y han llegado a ser el método estándar para la fijación posterolateral y fusión de la columna dorsal, lumbar y sacra. En nuestro medio el uso de ese tipo de instrumentación es muy limitado debido a la poca disponibilidad de estos sistemas en el mercado local y al costo de los mismos. En manos de cirujanos espinales entrenados y experimentados este sistema tiene una elevada tasa de seguridad, efectividad y menor número de complicaciones que cualquiera de los otros sistemas de instrumentación disponibles en nuestro medio. Presentamos los resultados preliminares del primer estudio prospectivo en nuestro país sobre este tipo de instrumentación en 33 pacientes sometidos a fijación espinal con tornillos transpediculares, haciendo también una revisión bibliográfica del tema, exponemos nuestras experiencias y los resultados obtenidos.CONCLUSION: El sistema transpedicular puede ser usado de forma confiable tanto en trauma como en patología degenerativa de la columna dorsal y lumbosacra. La fijación nos permite conseguir una remisión de dolor espinal en el 100% de los casos, una buena tasa de fusión ósea, mínimas complicaciones y reicorporación temprana de los pacientes a sus actividades...(AU)

Evaluation of indication-based use of transpedicular instrumentations with different rigidity for lumbar spinal fusion: a prospective pilot study with 3 years of follow-up.

In a prospective cohort study in 94 patients with 3 years' follow-up the efficacy of rigid and semi-rigid transpedicular instrumentation for lumbar spine fusion was evaluated via three established scores. Patient groups were similar in respect of anthropometric data. The indication for using the semi-rigid technique was a fairly stable intraoperative situation; for the more common unstable situations, the rigid technique was chosen. Selecting implant rigidity on these criteria led to results with an improvement rate well within the upper success range reported in the literature. Among people in employment, a lengthy preoperative sick leave was an important predictor for unsatisfactory outcome.

A novel vacuum device for extremity immobilisation during digital angiography: preliminary clinical experiences.

Our objective was to develop and evaluate a non-invasive device for rigid immobilisation during extremity angiography. The patented BodyFix immobilisation device (Medical Intelligence, Schwabmünchen, Germany) consists of a vacuum pump connected to special cushions and a plastic foil that covers the body part to be immobilised. First, the patient's extremity is covered by a thin plastic bag and then wrapped in one of the cushions, placed on the top of the therapy couch, and covered with the plastic foil. The air is evacuated from the cushion under the covering foil by the vacuum pump, resulting a hardening of the cushion and thus immobilisation of the patient's extremity. The rigid immobilisation resulted in a complete absence of motion artefacts in the majority of patients. No pixeling of the images was required in any of the 100 patients vs 32% in the control group. Repetition of series could be avoided in all cases and a substantial increase in the quality of the images was obtained. Setup of the device takes an additional 1-2 min. Vacuum immobilisation allows for comfortable, effective immobilisation during digital subtraction angiography, eliminating motion artefacts. This device has become an indispensable tool in daily clinical routine at our department.

Single Price/Case Price Purchasing in orthopaedic surgery: experience at the Lahey Clinic.

BACKGROUND: Hospital revenues for orthopaedic operations are not keeping pace with inflation or with rising hospital expenses. In an attempt to reduce the hospital cost of orthopaedic operations by reducing the cost of operating-room supplies, we developed a Single Price/Case Price Purchasing Program for implants used in total hip arthroplasty, total knee arthroplasty, and total shoulder arthroplasty as well as for arthroscopic shavers and burrs, interference screws, and bone-suture anchors. METHODS: The Lahey Clinic asked orthopaedic vendors to supply all instruments, implants, and disposable items related to these selected products for one single price per unit or case. For example, a single price for total hip arthroplasty implants included instruments, acetabular cups, acetabular liners, acetabular screws, femoral stems, femoral heads, and stem centralizers, if required. The hospital implemented the Single Price/ Case Price Purchasing Program with a competitive-bid request for proposal. Surgeons evaluated the responses to the bidding process, and they made final decisions on product selection. RESULTS: The Single Price/Case Price Purchasing Program at the Lahey Clinic was successful in reducing the cost of orthopaedic implants and supplies. In the present article, we could not disclose the specific prices that we agreed to pay our vendors. The specific cost reductions were 32 percent for hip implants with a change of vendor, 23 percent for knee implants without a change of vendor, 25 percent for shoulder implants with a change of vendor, 45 percent for arthroscopic shavers and burrs without a change of vendor, 45 percent for interference screws without a change of vendor, and 23 percent for bone-suture anchors without a change of vendor. CONCLUSIONS: The Single Price/Case Price Purchasing Program at the Lahey Clinic allowed the hospital to reduce its cost of orthopaedic operations by lowering the cost of operating-room supplies. This cost reduction is important in a health-care economy in which hospital revenues per unit of service or care are decreasing.