Radiological analysis of 37 segments in cervical spine implanted with a peek stand-alone device, with at least one year follow-up.

BACKGROUND: High incidence of subsidence in cervical stand-alone cages was reported in the literature. PURPOSE: The goal of this study was to assess the radiological outcomes of a PEEK anchored stand-alone cage (MC+®) with a minimum of 1 year follow-up. STUDY DESIGN: A retrospective radiological evaluation. PATIENT SAMPLE: The study was conducted in 4 hospitals and involved 28 patients (37 levels) treated by ACDF (Anterior Cervical Discectomy and Fusion) for spondylotic radiculopathy and/or myelopathy. OUTCOME MEASURES: We analyzed fusion, disc height, cage or anchor micro plate migration, discal and segmental lordosis and subsidence. METHODS: All the patients were controlled at least one year after surgery with an average of 31 months. Antero-posterior and lateral X-rays were performed pre-operatively, immediate post-operatively, and at final follow up. The different radiographic measurements were performed with the assistance of software (SpineView®). CT-scans were performed for each case at final follow-up to assess the fusion. RESULTS: No migration or breakage was reported for either the cage or the anchor micro plate. The fusion rate was 94.1% at the final follow-up. No subsidence was observed. The disc height increased between preop and final follow-up from 23.3% to 44.3%, from 22.1% to 35.1% and from 38.3% to 51.5% for anterior, posterior and midline disc height respectively. Mean Functional Spinal Unit Lordosis increased from 0.9° preop to 3.0° at final follow-up. No new kyphotic situation could be noticed. At the final follow-up, 96% of the patients stated they would undergo the procedure again. CONCLUSION: With a high rate of proven fusion, restoration of disc height and spinal alignment in most cases, and absence of subsidence or migration, our radiological results with MC+® at more than 1 year of follow-up show the implanted device to be safe and effective for use in treating degenerative conditions of the cervical spine.

Functional and radiographic outcome of thoracolumbar and lumbar burst fractures managed by closed orthopaedic reduction and casting.

STUDY DESIGN: Retrospective review. OBJECTIVES: To determine clinical and radiographic outcomes of thoracolumbar and lumbar burst fractures without neurologic injury treated by closed reduction and casting. Patient factors associated with poor outcome are identified. SUMMARY OF BACKGROUND DATA: The results of ambulatory bracing, surgery, and prolonged recumbency for burst fractures have been reported. There are no reports of results of closed reduction and casting. METHODS: Retrospective review of 41 neurologically intact patients with thoracolumbar and lumbar burst fractures was performed. Four patients with neurologic injury who refused surgery were included, for a total of 45 patients. All patients had closed reduction and casting. Functional, pain, and employment status were assessed using the Denis system. Neurologic function was graded using the Frankel scale. Radiographic evaluation of vertebral kyphosis, regional kyphosis, anterior body compression, and sagittal index were performed at time of injury, postreduction, 4 months, and final follow-up. RESULTS: Sixty-four percent of patients had minimal or no pain. Eight percent had constant, severe pain. At time of injury, 71% of patients were employed. At 8-month follow-up, 58% of patients were employed. Closed reduction resulted in significant correction of vertebral wedging from a mean of 15 degrees to 5 degrees. Deformity tended to recur by 4 months, but the degree of residual deformity appears to be less than that reported in other series. No complications resulted from the fracture reduction procedure. CONCLUSIONS: Closed reduction and casting of thoracolumbar and lumbar burst fractures is a safe treatment method that yields acceptable functional and radiographic results.

Health technology assessment for medical devices in Europe. What must be considered.

OBJECTIVE: To inform about the specifics of medical devices and the resulting consequences for health technology assessment (HTA) and to present the European industry position on this topic. METHODS: The paper is based on an intensive debate within Eucomed, the European trade association in the field of medical devices, informed by an HTA Experts Group, comprising experts from within and outside the medical device industry. RESULTS: Based on the specifics of medical devices, there are a number of methodologic considerations that require a tailored HTA, differing from the approach taken for, for example, pharmaceutical products. These differences have an impact on the selection of the technology, the timing of the assessment, the study design, and the patient population. CONCLUSION: The European medical device industry can commit to an HTA that takes into consideration the specifics of medical technologies, which is appropriate and fair, and which is done under full participation of industry. Under these circumstances HTA can be a useful tool to support rational decision making in health care.