Accreditation for Cone Beam Orthopaedic Imaging: Answers to 7 Questions

Providers must be accredited by a CMS-approved organizationCarestream OnSight 3D Extremity System

The process for securing accreditation for Cone Beam CT orthopaedic imaging can be a bit confusing. However, it’s a necessary process. Any facility performing CT scans must obtain accreditation prior to receiving reimbursements from Medicare and many private payers.

The process for securing accreditation is worth it. Adding the capability for in-house cone beam CT exams can have major benefits for orthopaedic practices. It can help speed your workflow, boost your productivity, and support a higher standard of care. It can even help differentiate your practice from the competition.

Read on to learn the simple answers to 7 common accreditation questions. Continue reading

Building Orthopaedic Practice Revenue: Four Economic Models

Evaluating the economic impact of the OnSight 3D Extremity System

 

Before investing in a new piece of imaging equipment, orthopaedic practices need to understand the potential financial impact. Contribution to patient care is paramount; however, so is the potential to increase orthopaedic practice revenue.Chart showing financial impact

The Carestream OnSight 3D Extremity System is a novel and relatively new Cone Beam CT (CBCT) scanner designed for easy, day-to-day extremity evaluation in the orthopedic practice.  As this technology becomes more widely available, orthopedic practices need to understand the economic implications of owning this next generation clinical tool. Continue reading

Aunt Minnie Names OnSight 3D Extremity System ‘Best New Radiology Device’

Customer Input Drives Carestream’s Engineering Innovation

Carestream was proud to receive the Aunt Minnie award for Best New Radiology Device at RSNA16 in Chicago. The prestigious award was given to Carestream for our innovative OnSight 3D Extremity System that brings a new modality and clinical value to the orthopaedic market.

Andrew Hartmann, Carestream’s Vice President and General Manager for ultrasound and cone beam CT; and Jim Burns, Chief Technology Officer, X-ray Solutions at Carestream, sat down at RSNA16 to talk about what drives the company’s product innovation. The dominant themes: customer input and innovation.

Carestream spends considerable time interacting with customers to design and refine its products. Customers at RSNA commented on different features in the product that they had proposed during the design process.

Similarly, about 100 sonographers, physicians, radiologists, radiology administrators, and sonography students from throughout the world touched, prodded, and gave feedback on Carestream’s Touch Prime Ultrasound product throughout its development.

A second theme in the conversation was innovation. 3D cone beam is a new modality and Carestream is making it available to a new market segment: orthopaedic offices. By doing so, Carestream is broadening the possibilities for clinical collaboration and changing the clinical workflow. By moving the modality closer to the patient, it paves the way for an improved patient experience. CBCT imaging provides more information to the surgeon over 2D X-ray with the added convenience of potentially fewer office visits for the patient.

Customer input and smart engineering innovation: it’s an award-winning combination. Listen to the full conversation between Jim Burns and Andrew Hartmann.

Orthopaedic Practice: 4 Ways to Increase Revenue

In-house imaging provides orthopaedic practices with ancillary revenue stream

“Where you win or lose the game in a medical practice is on the revenue side of the balance sheet.”

Orthopaedic practices, like all medical practices, are feeling the pinch of increased costs, reimbursement pressure, and time-consuming administrative procedures. But on the positive side, there are many opportunities to increase revenue to make your orthopedic practice not only more Chart shows revenue increasingprofitable, but more efficient, for and more satisfying for your patients.

The AAOS created a useful 45-page guide, Enhancing Your Practices Revenue: Pearls and Pitfalls (A Primer for Orthopaedic Surgeons (1). It gives excellent recommendations for adding services, staff, and equipment that are likely to generate incremental revenue in an orthopedic practice.

These suggestions include Non-Physician Extenders (NPEs) such as Physician Assistants (PAs), Nurse Practitioners (NPs), and Athletic Trainers (AT/ATCs), who can “increase physician productivity, patient satisfaction, quality of care, and physician revenue.” Another idea for ancillary revenue generation for orthopedic practices is to add non-surgical physicians who can provide coverage when the surgeon is in the OR. Urgent care centers are another opportunity to make use of your physical set-up and location to build revenue after hours or on weekends.

Continue reading

Carestream OnSight 3D Extremity System Gains FDA 510(k) Clearance

Aunt Minnie Selects OnSight Product as Finalist for “Best New Radiology Device”

Editor’s note: the CARESTREAM OnSight 3D Extremity System was named the winner for Best New Radiology Device by Aunt Minnie in October!

September has been a big month for our CARESTREAM OnSight 3D Extremity System. The product received FDA 510(k) clearance and is available for order in the United States. It was also selected as a Finalist for “Best New Radiology Device”by Aunt Minnie. The publication chose the product in part because of the niche it fills – “a small CT scanner designed for extremity studies”.Carestream OnSight Aunt Minnie finalist

This affordable, compact system offers high-quality, lower-dose 3D imaging studies (compared to traditional CT) for use by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers. The system also comes with 3D software from Carestream designed to give orthopedic specialists more information on pathology than what might be possible with 2D imaging.

The extremity imaging system can help in treating a host of orthopaedic conditions that affect the biomechanical behavior of the joints such as arthritis, meniscus loss, instability and malalignment syndromes. The system also offers less radiation than traditional CT systems while delivering excellent image quality.

A key feature of the product is its ability to capture weight-bearing images. Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo recently concluded a study, noting the benefit of weight-bearing images for orthopaedic patellofemoral diagnosis.

Orthopaedic imaging is a major focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages. Youth and adults often suffer sports-related injuries to their knees, ankles and feet while older adults experience arthritis, joint instability, meniscus loss and other conditions.

Carestream’s new extremity imaging system enables healthcare providers to capture high-quality 3D images and conduct a patient consultation in a single visit—which helps improve productivity and convenience for both specialists and patients. An additional benefit is the ability for patients to view a 3D image that illustrates their condition or injury to help them understand the reason for a treatment or surgical procedure.

The OnSight 3D Extremity System will be demonstrated at the American Society for Surgery of the Hand (ASSH) conference that begins on Sept. 29.

#NHITweek

Editor note: In Europe, the device cannot be marketed or sold until compliant with 93/42/EEC.

 

Helen Titus

Helen Titus is the worldwide X-ray & Ultrasound Solutions Marketing Director at Carestream

Research: Impact of Weight-bearing Images in Orthopaedic Imaging

Study favors weight-bearing images for orthopaedic patellofemoral diagnosis and surgery

In clinical orthopedics advanced imaging like computed axial tomography (CT) scanning, has become invaluable to the evaluation and management of patients with musculoskeletal disease. Bone detail is much better visualized with 2D and 3D CT renderings of patients with problems like glenoid fracture, failed shoulder instability surgery, and meniscal root avulsions.

Conventional CT technology requires subject in supine position

High-quality images provide multiplanar 2D and 3D visualization for practitioners who think and work in three dimensions. However, a significant limitation of CT technology has been that it forces image acquisition with the subject in a supine, relaxed position. When imaging an injured knee, for example, the leg is in full extension and the muscles relaxed.

The conventional measures of patellofemoral alignment include the congruence angle, patellar tilt angle, and tibial tubercletrochlear groove offset distance. There are clearly defined limits of normal use for each of these measures, and they are used by surgeons to plan corrective operations on the patellofemoral joint. The degree of knee flexion and activity of the quadriceps are known to influence patellar tracking on the trochlea, but these factors are removed when images are taken with the patient supine.

Some have tried to simulate weight bearing in a CT scanner by custom designing a rig to apply longitudinal  load  through  the  patient  for  imaging  of  the  spine or  lower  extremity. These  methods  are  at worst,  a  poor depiction  of  functional  anatomy;  and  at  best , a cumbersome  and a less-than-accurate simulation of function.

Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo undertake study

Myself and other researchers from the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo are currently performing research on a new  cone  beam CT scanner,  the  CARESTREAM OnSight  3D  Extremity  System,  developed by Carestream Health. The system is designed to offer high-quality, portable,  low-dose  3D  point-of­ care imaging by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities, and other healthcare providers.

We have been performing institutional IRB-approved clinical trials and basic sciences studies with the prototype model. These studies are being carried out at the Erie County Medical Center, Buffalo’s regional orthopedic tertiary care facility. Based on early data, we are convinced that many imaging studies should be acquired with subjects in positions that represent true human function, such as weight bearing on the lower extremities.

Comparing Carestream OnSight 3D Extremity System to predicate devices

We compared the 2D imaging performance of the CARESTREAM OnSight 3D  Extremity System to the predicate CARESTREAM DRX-1 Detector used with the CARESTREAM DRX-Evolution System. We compared the 3D volumetric imaging performance of the OnSight system to a multiple detector computed  tomography (MDCT) scanner  (“predicate device”). The purpose of the study was to demonstrate equivalent diagnostic  image quality between the investigational and predicate devices, using a Radlex subjective quality rating scale.

The evaluation was performed on equal numbers of knees, ankles, feet, elbows, and hands from 33 cadaveric human specimens and 13 living human subjects. Four independent, board-certified radiologists of varying general reading experience performed evaluations of the images/exams captured using both the investigational and predicate devices.

Results: OnSight 3D Extremity System produced 2D images with equivalent diagnostic image quality to predicate system

In summary, the CBCT system produced 2D images with equivalent diagnostic image quality to the predicate system for a range of exams, and 3D images were rated equal or better when compared to the predicate device for a range of exams on cadaveric specimens and human subjects.

  • More than 80% of all the 2D images were rated diagnostic or exemplary, whereas approximately 98% of all 3D images were rated diagnostic or exemplary.
  • More than 75% of all Radlex rating responses counted for all 2D images were rated equivalent or favored the investigational device.
  • Approximately 85% of the Radlex rating responses counted for the 3D images were rated equivalent or favored the investigational device.

Examples of representative scans are seen below.

2D and 3D orthopaedic renderings generated by the CBCT scanner

Figure 5: 2D and 3D renderings generated by the CBCT scanner

Our conclusion from this study is that for cases of patella instability, it may be desirable to obtain images while the patient is weight bearing on a flexed knee with their quadriceps muscles active. Improvement in objective measures of patella alignment should lead to improved clinical and surgical care of patients with this condition.

New study: comparing measures of ankle stability

A second clinical study is currently under way to take advantage of the unit’s ability to obtain images in weight bearing. The research will compare measures of ankle stability from the investigational weight-bearing cone beam computed tomography scanner to the same measures on gravity stress X-ray in patients who have supination-external rotation ankle fractures.

These and future studies may validate the value of the OnSight 3D Extremity System. Potential benefits include better quality images with a lower radiation dose than conventional computed tomography. The unit is proposed for use in orthopedic offices, but it might have applications to the operating room or at athletic competition sites. The unit is less expensive than a traditional in-hospital or radiology center CT scanner, and can be used with existing electrical systems (220V). Most important however, is the potential to acquire images while bearing weight and in more functionally relevant positions.

Editor’s note: The CARESTREAM OnSight 3D Extremity System received FDA 510(k) clearance in September 2016 and is available for order in the United States.

Dr. John Marzo, UBMD

Dr. John Marzo is a physician with UBMD Orthopaedics & Sports Medicine, Associate Professor of Clinical Orthopaedics, Jacobs School  of  Medicine  and  Biomedical  Sciences,  University at Buffalo and  former  Medical  Director,  Buffalo Bills. He is also a member of Carestream’s Advisory Group, a collective of medical professionals that advises the company on healthcare IT trends.