Stuart Miller, MD, is an orthopedic surgeon at MedStar Union Memorial Hospital and assistant professor at Johns Hopkins University School of Medicine, both based in Baltimore.
Dr. Miller spoke with Becker's Spine Review about trends in the orthopedic fixation market, orthobiologics and proper implant selection.
Question: What trends do you see in the orthopedic fixation market?
Dr. Stuart Miller: The market is undergoing consolidation as more healthcare systems seek to lessen the number of suppliers and to maximize efficiency. Despite this direction, several smaller companies are finding success with technological innovation. Cartiva introduced an implant for joint preservation, CrossRoads Extremity and MedShape have engineered better nitinol for bone fixation. The big companies are no longer [research and development] machines but more distribution systems, placing the onus of innovation on the smaller, more mobile companies.
Q: How does Ossio's OSSIOfiber differ from other orthopedic fixation platforms currently on the market?
SM: OSSIOfiber is a matrix of thousands of mineral fibers custom orientated with polymer acting as a glue. The resultant material is stronger than PEEK implants yet will be replaced by bone gradually over time. The process is very different from the bio-resorbables, such as [polylactic acid or polyglycolic acid], which would dissolve and then bone would fill in the gap. OSSIOfiber starts out stronger than cortical bone, and the bone cells adhere and infiltrate the implant, osseointegrating. The elimination of the bone/implant interface is very exciting and demonstrates a new class of bio-integrative implants.
Metals and plastics such as PEEK will always be a foreign object in and on the bone. Differences in mechanical characteristics will eventually be accommodated by the healing bone or will cause problems with the bone implant interface. The early enthusiasm for bio-resorbables a decade ago faded with the complications of sterile abscesses as well as the problems of degradation irritation of tissues. OSSIOfiber offers the benefits of bone allograft, complete incorporation into and replacement by native bone, without the adverse issues resulting from early resorption or infectious disease worries.
Q: Do you expect to see more bio-integrative materials used in orthopedics along the lines of OSSIOfiber Intelligent Bone Regeneration Technology?
SM: I would hope so. This material seems to be a kind of ‘Holy Grail’ of implant technology, offering early stability and later bio-integration. Ossio is currently developing and testing other implant designs, such as bone screws and anchors, with wonderful promise.
Q: What should orthopedic surgeons consider when choosing appropriate implant systems?
SM: First, the surgeon demands safety: that implants will cause no harm. Second, the system must be efficient, effective and perform its function, usually to facilitate bone healing. Third, the system should be cost-effective.
History has demonstrated commercial enthusiasm for devices that seemed great at first. Charnley's first 300 hips with Teflon coating all failed; better engineering led to metal and polyethylene interface. The early biologics, such as the Restore patch, had real immunologic issues; now allograft and xenograft patches enjoy clinical success. The bio-resorbable screws seemed good at first; although, uneven resorption and loose chunks in joints caused problems, which have yet to be resolved. Some [polylactic acid]devices continue to enjoy use but with guarded application. The PGA/PLA composites were to incur a more ‘amorphous’ degradation, but the handling characteristics such as the brittleness of the screws led to discontinuance. The OSSIOfiber offers the next generation of bio-resorbables, which can bio-integrate much more smoothly and reliably.
The implant systems must offer better fixation opportunities. Strong implants allow for early motion and rehabilitation. Patients are better informed than ever and want the best solutions. Hospital systems, faced with a myriad of surgeon preferences, are beginning to demand physician justification for one implant over another; new devices are hard to introduce into a hospital system framework. The days of ‘me too’ implant systems, driven by a surgeon preference due to a golfing buddy, are gone.
The new payment paradigms of bundled-reimbursement will not be favorable to implant removal. Systems that offer significantly less risk of needing to remove the implant become more important. Personally, I hate hardware removal. It takes up operating room time and my time which could be better served treating the initial disease instead of the disease intervention. I look forward to the time, I think not too far in our future, when we wonder why orthopedic surgeons used metal to hold bone for so many years.
Q: How are the Ossio implants increasing efficiencies in the clinical space?
SM: OSSIOfiber will facilitate firm bone stability, allowing early healing. The implant systems will be efficient and cost-effective. Implants that work with reliable mechanical integrity are essential; this material is strong and stable. Eliminating later need for hardware removal has an enormous benefit in overall healthcare system efficiency as well.
Q: What are some key factors driving change in the orthopedic care field today?
SM: As in so many aspects of modern life, technology drives the changes in orthopedic care. The marked improvements in imaging, biologics and pharmacology have been wonderful; now implant design takes us into the next realm. Materials which are more like bone and are replaced by strong, healthy bone will hopefully make metal essentially obsolete. The stress shielding of metal can have long term issues with bone health, as can the ability of metal to harbor infection. An implant that bio-integrates and becomes replaced by living cells offers a far better biologic solution.