The future of fracture repair may include 3D-printed synthetic bone

Scientists fix fractures with 3D-printed synthetic bone (MassDevice)
Scientists in the United States have successfully treated broken spines and skulls in animals using 3D-printed synthetic bone, opening the possibility of future personalized bone implants for humans to fix dental, spinal other bone injuries.

Unlike real bone grafts, the synthetic material – called hyper-elastic bone – is able to regenerate bone without the need for added growth factors, is flexible and strong, and can be easily and rapidly deployed in the operating room.
Giving details in a teleconference, the scientists said the results of their animal trials – published on Wednesday in the Science Translational Medicine journal – were “quite astounding”.
Human trials could begin with five years, they said.
The team found that when used in spinal injuries in rodents and to mend the skull of a monkey, the hyper-elastic bone, made mostly of a ceramic and polymer, quickly integrated with surrounding tissue and began regenerating bone.
It swiftly mended bones in the spines of the rats and healed the monkey’s skull in just four weeks, with no signs of infection or other side effects, the scientists said.
“Another unique property … is that it’s highly porous and absorbent – and this is important for cell and tissue integration,” said Ramille Shah of Northwestern University’s department of material science, engineering and surgery, who co-led the work.
“Even when it’s deformed or squeezed into a space, it still maintains high porosity, and this is also very important for blood vessels to infiltrate the scaffold so that it can further support cell and tissue growth.”
Other types of bone grafts currently in development are often too brittle to be shaped and handled by surgeons, and risk being rejected once inside the body, or may be too expensive or difficult to manufacture for widespread use.
With this hyper-elastic bone, however, many of those issues would be overcome, said Adam Jakus, Shah’s co-researcher at Northwestern University.
“It’s purely synthetic, very cheap and very easy to make,” he said. “It can be packaged, shipped and stored very nicely.”
Shah she hoped these properties would mean patients in developing countries would also benefit.
“There are a lot of paediatric patients, especially in third world countries, who are born with orthopaedic or Maxillofacial(face and jaw bone) defects,” she said. “And because the hyper-elastic bone is scalable at a low cost, (we hope) it would be accessible to those types of patients.”

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Medtronic disentangles from the Dr Durrani off-label INFUSE lawsuits

MEDTRONIC DISENTANGLES FROM DURRANI INFUSE LAWSUITS (Orthopedics This Week)
Medtronic plc actually had good legal news on September 23, 2016, regarding an Infuse lawsuit.
Spine patients in Ohio who had back surgery performed by federal fugitive, Atiq Durrani M.D., joined together to sue Medtronic because Durrani used Infuse in an alleged off-label fashion. Durrani is currently practicing back surgery on Pakistanis after fleeing the country just ahead of a Department of Justice (DOJ) posse on his tail for alleged Medicare false claims. He was the top Medicare billing doc in Ohio for a couple of years.
The good news for Medtronic is that the judge overseeing the combined cases ruled that there was no case because all but the fraud claims were pre-empted and fraud allegations were too vague.
The patients’ claims included alleged fraud; product liability for failure to warn, design defect, misrepresentation and negligence; and breach of warranty, according to court documents.
Most Wanted List
Durrani has made it up to number 18 on the DOJ’s “Most Wanted” list. See the list here.
He was indicted in 2013 on charges of health care fraud, false statements related to health care matters, mail fraud, and illegal drug distribution. Prosecutors said Durrani billed for millions for medically unnecessary procedures.
Durrani fled the country after his arrest in 2013. We reported in June 2015 that he was practicing as an orthopedic surgeon in Pakistan.
On its “Most Wanted” list, the government says Durrani often told patients that the medical situation was urgent and that surgery was needed right away or they would be at risk of suffering from grave injuries. For cervical spine patients, Durrani often told patients that there was a risk of paralysis or the head would fall off if the patient was in a car accident.
Durrani, said the indictment, never read patient radiology reports; rather he provided his own reading, which was either inconsistent with or contrary to the reports written by the radiologists.
The hospital where he practiced in Cincinnati paid $4.1 million in October 2015 to settle claims that the hospital billed for medically unnecessary spine surgeries.
Finally, the government says Durrani dictated his operative reports and other patient records months after the actual treatments. These reports and records contained false statements about the diagnoses of the patients, the procedures performed, and the instrumentations used in the procedures. In addition, Durrani failed to inform his patients of complications experienced during the surgeries.
Durrani Credentials
After he fled the country, we learned that Durrani had set up his own spine surgery clinic and joined the staff of a large hospital in Lahore, Pakistan. The hospital advertises that its surgeons are “U.S. Board Certified.”
Durrani claimed to be a “Diplomat” of the American Board of Orthopedic Surgeons (ABOS) on various websites. However, a web search of the ABOS website did not turn up the name of any orthopedic surgeon named Atiq Durrani. The ABOS also confirmed that no one by that name is U.S. board certified.
We contacted the hospital to ask about this, but received no reply.
According to a recent Brad Perriello MassDevice story, the Lahore hospital does not list him on its website.
We looked for him again. And found him at http://www.osi.com.pk/. He’s still cutting into people in a clinic in Pakistan and still lists all his claimed credentials. We asked Durrani for comment about his use of Infuse. Have not had a response yet, but our request went out in the middle of the night in Pakistan.
Durrani is still on the lamb, but Medtronic seems to have untangled itself from his legal troubles.

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1st Osteo-Integrated surgery performed in California

FIRST OSTEOINTEGRATED SURGERY PERFORMED IN CALIFORNIA (Orthopedics This Week)
Read more:  The osteointegrated prosthesis is one of Tigers 13 Trends
Daniel C. Allison, M.D., a board-certified orthopedic surgeon in Los Angeles, is preparing to perform the first bone anchored (osteointegrated) prosthesis surgery to be done in Southern California. The patient had previously had an above-the-knee-amputation.
“We are very excited to be the first practice in Southern California to offer the surgery,” said Allison. “We are constantly working to bring the latest surgical innovation techniques to our joint replacement and hip arthroplasty treatments.”
Surgeons installing traditional prosthetics use a ball and socket design. The socket is placed around the end of the affected limb, to which the prosthetic arm or leg is then attached. This approach requires enough surface area on the remaining limb to adequately attach the cap with the socket. It can also present issues with comfort and fit, according to the September 18, 2016 PRWeb press release.
In making use of the Osseoanchored Prosthesis for the Rehabilitation of Amputees (OPRA), manufactured by Integrum AB in Molndal, Sweden, surgeons implant a titanium fixture directly into the bone. Using a titanium implant, they say, helps to mitigate the risk of rejection from the bone. Once the fixture has integrated and healed, surgeons attach a rod through the skin, which then connects to the prosthetic leg. The benefits of this approach include greater mobility, range of motion, and comfort. It also offers hope for amputees who are not good candidates for or have had limited success with traditional socket prosthetics.
The OPRA prosthesis has been approved by the FDA (Food and Drug Administration) for use in above the knee amputees. “With proper care and comprehensive physical therapy and rehabilitation, we are very optimistic that this approach will offer a significant improvement in quality of life for many adults, especially veterans with above-the-knee amputations,” said Allison.

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Study: SI-BONE is a clear winner at 2 years out

SI-BONE: IFUSE SHINES IN RCT (Orthopedics This Week)
SI-BONE, Inc. is announcing two-year results from the INSITE (Investigation of Sacroiliac Fusion Treatment) study, a prospective randomized controlled trial (RCT) of MIS (minimally invasive surgery) SI (sacroiliac) joint fusion with iFuse compared to non-surgical management (NSM).
According to the August 24, 2016 news release, the researchers found that “rapid improvements in pain, disability and quality of life for the iFuse group were larger than those seen for the NSM group and were durable to two years…148 subjects were enrolled, randomized 2:1 (102 iFuse/46 NSM), and treated at 19 centers in the United States including both private practice and academic institutions. In the iFuse group, the mean SI joint pain score improved from 82.3 at baseline to 30.1 at 6 months, 28.6 at 12 months and 26.7 at two years, corresponding to improvements from baseline of 52.3, 53.7 and 55.4 points, respectively. Disability, as measured using the Oswestry Disability Index (ODI), decreased from a mean 57.2 at baseline to 29.9, 28.3 and 28.7 at months 6, 12 and 24, representing mean improvements of 27.4, 28.9 and 28.4 points, respectively.
“The revision surgery rate was low at 3.4% (3/89) consistent with previously reported long-term results for iFuse and roughly one-third that for lumbar fusion surgery Two-year results also showed a 29.7% decrease from baseline in the number of study subjects taking opioids which is consistent with a 28% reduction in opioid use observed in a previously reported prospective multicenter two-year study.”
“These two-year results from the INSITE study illustrate the durability of SI joint fusion with iFuse and further validate previously reported 6- and 12-month results that showed rapid improvement in pain, function and quality of life in this highly debilitated patient population,” said Frank Phillips, M.D. of Rush University Medial Center.
Jeffrey Dunn, president and CEO of SI-BONE, told OTW, “There is now high quality Level 1 evidence in the form of two RCTs and a third large, prospective, multicenter study on iFuse for MIS SI joint fusion. These two-year RCT results further strengthen the findings documented in more than 40 previously published papers on iFuse and show pain, disability and quality of life improvements are immediate and sustained to 2 years. These long term positive results are consistent with previously reported 3-, 4.5- and 5-year results. No other SI joint fusion device is supported by published clinical evidence, much less randomized controlled trials. Furthermore, these results show that the number of iFuse patients requiring opioids is reduced by almost 30% and revision rates were low at 3.4%, about one-third that of lumbar fusion.
“Over the next 12 months, we plan to continue to demonstrate the clinical and economic benefits of iFuse, expand reimbursement coverage for all patients in need of this procedure and continue to educate patients and health care professionals about the importance of proper diagnosis and treatment of SI joint disorders. We will also continue to work with societies and organizations such as NASS, ISASS, CNS/AANS, ASIPP and Blue Cross Blue Shield Association to support education for the iFuse procedure.”

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Zimmer Biomet's new Vanguard Knee will “revolutionize" TKA

ZIMMER BIOMET’S NEW VANGUARD KNEE WILL “REVOLUTIONIZE” TKA (Orthopedics This Week)
Zimmer Biomet Holdings, Inc.’s new Vanguard Individualized Design (ID) knee implant will “revolutionize total knee replacement,” by “respecting” soft tissue.
Todd Davis, the company’s vice president and general manager of global knee business, made the bold prediction in a September 20, 2016 press release announcing the introduction of the implant.
Davis says the device has the ability to fine tune the knee’s balance through the use of independent medial and lateral bearing thickness and constraint options. “We will arm the surgeon with the ultimate soft tissue respecting capability.”
The device does this by incorporating two individual polyethylene bearings with different articulations on the medial and lateral sides. Traditional total knee implants feature a one-piece bearing constructed of polyethylene which is placed between the metal portions of the implant. The Vanguard ID’s flexible design allows surgeons to mix and match bearings of differing thickness and geometry, “ensuring they can personalize their approach to accommodate and preserve natural soft tissue,” stated the announcement.
The original Vanguard Knee system, which Biomet, Inc. introduced in 2003, pioneered personalization in knee replacement by offering the broadest range of available sizes, says the company. “By equipping surgeons to combine a vast number of bearings of varying thickness (up to 2 mm) and articulations to ensure a personalized feel, the Vanguard ID builds on the Vanguard knee’s legacy of enabling surgeons to create a personalized fit, while maintaining surgical simplicity and intraoperative flexibility.”
Tom Aleto, M.D., of the Missouri Orthopedic Institute in Columbia, Missouri, said he believes he is achieving higher patient satisfaction with the Vanguard ID. “Maintaining natural ligament tension while preserving healthy soft tissue is critical not only to restore normal range of motion but to achieve patient satisfaction. In traditional knee design, surgeons typically release healthy soft tissues in an attempt to balance the knee and maintain feasible kinematics. Because the Vanguard ID allows me to mix and match components, I am able to individually treat each compartment while maintaining healthy soft tissues.

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