Lodox-Statscan: FDA and Trauma Use

• The Lodox-Statscan (LS) is a whole-body X-ray scanner for skeletal and soft tissue imaging, with low radiation doses
• Thoraco-abdominal studies can be obtained in 3-5 minutes using LS
• The amount of radiation used is approximately one-third of conventional radiography
• The Food and Drug Administration (FDA) approved LS for use in the USA
• The use of LS technology has been incorporated into the Advanced Trauma Life Support protocols of numerous trauma centers
• The Lodox-Statscan device (LS) was initially designed for the South African diamond-mining industry
• It was inteneded for conducting low-dose, whole-body scans on mining workers
• The LS was first used for medical applications around 1999

FDA Approval and Trauma Centers

• The Lodox-Statscan device got approved in the USA in 2002 by the Food and Drug Administration (FDA)
• It was for standard emergency and radiographic examination of trauma patients
• About 25 trauma centers across the globe have added the LS technology to their emergency management protocols
• The LS has become a useful diagnostic tool within medicine
• Recent publications show the device being effectively used in pediatrics, pediatric trauma, neurosurgery, forensic medicine, and internal medicine
• The Lodox-Statscan is currently the only FDA-approved device of its kind
• A new 2D/3D, full body scanner (EOS http://www.biospacemed.com) has been introduced to the market, but may not be applicable in injured patients

Technical Specs

• The LS is mounted on an X-ray tube emitting a collimated fan-beam of X-rays
• The opposite end of the C-arm has an X-ray detector unit that includes scintillator arrays linked to charge-coupled devices
• The C-arm travels at up to 138 mm/s along the table
• It takes 13 seconds to complete a whole-body anterior-posterior (a.p.) scan
• The C-arm can be rotated axially around the patient up to 90°
• Subsequent whole-body, horizontal beam, shoot-through lateral, erect, and oblique views can be attained
• The radiation dose from digital radiation compared to conventional dose varies from 72% for the chest to 2% for the pelvis, averaging at 6%
• The radiation skin-entry dose is 36 mrem (range 18-67 mrem) on average
• Meanwhile, the conventional dose is 591 mrem (range 20-2280 mrem)

Costs

• The acquisition costs for the LS machine are similar to conventional hospital imaging products
• The running and material costs are low because the device is compatible with digital computerized software via conventional computer hardware
• No extra staff, service or time costs are required

Fields of Application - Trauma Management

• Boffard et al conducted a clinical trial comparing effectiveness between the LS and the standard ATLS X-ray protocol when detecting injuries
• Compared to a.p. radiographs, no loss of information was reported in the cervical spine, pelvis, chest, the cervicothoracic junction, or in long bones
• Beningfield et al did a study of 39 patients that compared LS images with conventional images using a scoring system
• The digital images were judged as being superior for the lungs, soft tissues, and mediastinum

Studies

• Shenarts et al compared five-view conventional cervical spine radiographs with the gold standard computed tomography CT scan
• Sensitivity was at 54% for conventional X-rays and 96% for the CT scans
• Berry et al reported sensitivity at 73%, specificity at 100% and negative predictive value at 92%
• This was for conventional radiographs in detecting thoracolumbar lesions
• Guillamondegui et al founded sensitivity at 68% and specificity at 98%
• This was for conventional pelvic radiographs
• Overall sensitivity of LS imaging was 62% and specificity was 99%
• Sensitivity and specificity findings for individual body regions were similar to or better than conventional
• A modified ATLS protocol (Bernese) was done to lower radiography time before secondary survey

Time advantages

• Radiography time was reduced
• It went from an average of 37 to 26 minutes
• Scanning time was around 4 minutes with LS compared to 26 minutes with conventional graphs
• Total emergency room time remained unchanged at a median of 29 minutes

Pediatric Trauma

• Radiation effects are major in children
• They may affect the immature skeleton
• It interferes with chondrogenesis and reabsorption of calcified cartilage as well as bone at the growth plate
• Relative digital radiation and radiation skin entry doses with LS imaging may be suitable for pediatric polytrauma patients
• Maree et al measured the entry and effective doses of different radiological examinations in children using LS and Shimadzu radiography units in 2007
• They calculated a standard deviation for the entry dose of 0-0.6%
• Pitcher et al evaluated how effective LS machines were for pediatric polytrauma
• It was found to be effective for triage and had similar quality to conventional radiography
• Some revised their polytrauma imaging protocols from ATLS X-rays plus local radiographs to a new protocol
• New protocols comprise an LS a.p. and lateral bodygram
• Lodox scans were found to have enhanced diagnostic yield and shorter imaging times in the ER

Other applications

• The LS device has potential in this field.
• The device is used in the management of acute ventriculoperitoneal shunt dysfunction
• South African studies show benefits of the LS in forensic practice

Summary and Outlook

• The device is FDA-approved
• LS has been proven to be just as or slightly better than conventional radiographs
• CT scanning leads to increased costs and radiation exposure
• Combining the use of LS, focused abdominal sonography, and thorough clinical examination may reduce the number of CT scans needed
• The Ls is less effective in excluding lesions of the cervical spine
• Not be considered as a replacement for CT scans in the instances
• High-speed, high-quality and low-dose body images make this device high potential for the future