Microfracture still has a place in Cartilage Procedures

CARTILAGE PROCEDURES: INDICATIONS, TRENDS, AND COMPLICATION RATES (Orthopedics This Week)

New work from Rush University Medical Center in Chicago, Illinois, is shining a light on the trends in articular cartilage treatments. The study, “Management of Chondral Lesions of the Knee: Analysis of Trends and Short-Term Complications Using the National Surgical Quality Improvement Program Database,” was published in the November 22, 2018 edition of Arthroscopy.

Adam Yanke, M.D., assistant director of the Cartilage Restoration Center at Rush and co-author on the study, explained the rationale toOTW, “As we learn more regarding the treatment of articular cartilage defects, we are beginning to understand that not every treatment works for every lesion. This can mean that both lesion characteristics such as size and location, as well as patient characteristics such as age, BMI [body mass index], and activity level may have a significant effect on patient outcomes. Understanding the best indications for cartilage restoration should help improve our outcomes and overall success rates of these procedures.”

“Currently most cartilage procedures have subjective outcomes of 85% success with regards to pain relief; however, tighter indications may help improve these outcomes. Therefore, the purpose of this study was to evaluate whether or not new evidence has been shaping indications for these procedures.”

“A secondary aim of the study was to understand the reported complication rates for these procedures to help shape the discussion with the patient in the office. In order to evaluate this, we looked at the ACS NSQIP [American College of Surgeons National Surgical Quality Improvement Program] database to determine the overall rate of change of chondroplasty, microfracture, autologous chondrocyte implantation, and osteochondral transplantation incidence and associated complications from 2010 to 2016.”

“The most important finding was that there is a clear trend towards increased usage of reconstructive options such as autologous chondrocyte implantation and osteochondral graft transplantation. While evidence has supported these changes, it does not appear that we have seen the same reduction in marrow stimulation technologies such as microfracture as one might expect.”

“Similarly, many cartilage restoration procedures are being indicated for patients that are likely beyond the age where it will still be beneficial for them. Specifically, the largest percentage of patients undergoing chondroplasty is 45-54 years of age at 26.1% and the largest percentage in microfracture is the same at 27.8%.”

“While chondroplasty procedures can provide some palliative benefits, microfracture should be applied in a setting where there is likely benefit through tissue growth and maturation, which is less likely in this age group. The largest percentage in almost all restorative procedures (osteochondral grafting and autologous chondrocyte implantation) was 25-34 years of age. This range for these procedures is completely in line with what we would expect based on the best evidence we have. Complications rates for all procedures was 2.1% or less and many of these were not significant adverse events.”

“Based on these findings, I think we should reinforce strict indications for microfracture procedures and treat marrow stimulation with the same “level of respect” as other restorative procedures to both help improve outcomes as well as to not burn bridges for future cell-based treatment if necessary.”

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Review of Biomet/Apple MyMobility App

EARLY REVIEWS OF ZIMMER BIOMET/APPLE’S MYMOBILITY APP

Approximately two months ago, Zimmer Biomet announced the mymobility app which is meant to walk patients through pre- and post-op large joint arthroplasty care.

Joshua Carothers, M.D., an orthopedic surgeon at New Mexico Orthopaedics in Albuquerque, is one of the first users of this Zimmer Biomet/Apple product. He shared his early experiences with OTW. “While our experience in the study has been limited, with just a few patients enrolled so far, people are definitely excited.”

“mymobility feels cutting-edge. Patients like using the wearable technology to guide their activity pre- and post-surgery. The basic concept of using technology to make the experience better is resonating with patients and I’m excited about using mymobility to improve care for patients with insights on things like patient complications and re-admissions, to name a couple.”

This project is of particular importance to Zimmer Biomet’s CEO Bryan Hanson. “We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons.”

The mymobility app captures data from knee and hip replacement patients and shares it seamlessly with their doctors so that, as Jeff Williams, chief operating officer at Apple explained “They can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”

mymobility works using the Apple watch. According to Monica Kendrick, VP of Corporate Communications at Zimmer Biomet, the app will allow “Surgeons and care teams to send messages, step-by-step guides, reminders, exercise videos and more to patients and thus convert an arduous and independent process into a timed, simplified and supportive one.”

“Surgeons can also receive data on patient activity before and after the procedure, gaining unprecedented insight into the patient experience, which may help to identify potential complications and impact payment structures through patient satisfaction.”

“The mymobility app has the potential to generate a large and complete data set on preparation for and recovery from knee and hip replacement procedures, which may impact patient selection and the episode-of-care. Together, mymobility with Apple Watch and Zimmer Biomet’s mymobility Clinical Outcomes Study have the potential to affect outcomes, the patient selection process, and ultimately the pathways of care.”

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USING “STEM CELLS” IN A SPORTS MED PRACTICE: CASE STUDY

USING “STEM CELLS” IN A SPORTS MED PRACTICE: CASE STUDY (Orthopedics This Week)
Christopher Rogers, M.D., founder of the San Diego Orthobiologics Medical Group, recently drafted and blasted out a press announcement saying that his practice is now offering a new/old treatment called Lipogems for painful sports medicine type injuries. And that that treatment was a major advance in regenerative medicine.
Well. There is more to the story, but it is interesting and instructive to see how Dr. Rogers is using these advanced orthobiologics treatments to build his practice.
To put a face on his press announcement, Dr. Rogers offered professional soccer player, Brian Farber of the San Diego Sockers who was diagnosed with a torn patellar ligament and, according to the press announcement, after two years of debilitating pain, found relief at San Diego Orthobiologics with Lipogems.
Lipogems is a system that uses fat tissue from liposuction to create an injectable material which has been used for years in cosmetic surgeries to fill wrinkles or otherwise support sagging skin. Recent studies have found evidence that it can be effective in treating joint pain. Here is a link to a bibliography of those studies.
Using fat tissue to treat such orthopedic problems as arthritis or ligament pain is not new. Several companies developed stromal vascular fraction (SVF) systems over the years which used an enzyme-based system to extract “stem cells” and other helpful materials from patients’ fat tissue. The FDA decided that these systems fell under the rigorous cell-drug licensing category, which put a serious crimp in the SVF approach.
The manufacturer of the Lipogems system, Milan Italy-based Lipogem International, makes no claim of stem cell harvesting on their web site, and, instead, is marketing a 510(k) cleared adipose (fat) tissue processing device which may be used in, according to the 510(k) clearance, “for orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired.”
A typical Lipogems unit consists of a transparent plastic cylinder with filters and beads for the micro-fracturing of adipose tissue. The filters are fitted with Luerlock connectors to attach the syringes containing lipoaspirates and those for the collection of processed tissue. The processing unit along with the cannulas and set of syringes make up the Lipogems® kit.
According to Dr. Roger’s web site, the San Diego Orthobiologics Medical Group offers a full range of orthobiologics treatments including stem cell treatments, bone marrow aspirate treatments, platelet rich plasma (PRP) and alpha 2 macroglobulin, among other advanced therapies.
Furthermore, the Lipogem treatment as used at the San Diego Orthobiologics group is “a comprehensive Regenerative Medicine treatment that uses your own stem cells and their cellular ‘niche’ to maximize results. Mesenchymal stem cells require support from other cells and proteins to exert their healing benefits. Unlike other so-called ‘stem cell’ treatments, the unique advantage of LIPOGEMS® is that the complete healing environment of the fat tissue is maintained to improve cell viability and regenerative capacity. It allows improved cell viability over a greater period of time.”
The professional athlete who was treated with the Lipogems treatment had been struggling with debilitating pain two years after his knee injury and torn patellar ligament, and was seriously considering retiring from professional soccer.
According to the press announcement, after undergoing the Lipogem procedure six months ago, Farber went through a rehabilitation period, then physical therapy and progressive strengthening and treatment with BEMER (bio-electro-magnetic-energy-regulation) technology. And Farber is ready to play with his team again after just six months of treatment, a big contrast to the prior two years of ineffective treatment.

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Shark Tank Meets Spine Start Up VerteCore!

Shark Tank Meets Spine Start Up VerteCore!

TRACEY ROMERO
While most of the talk this summer has been about shark sightings and attacks along our beaches and Olympic swimmer Michael Phelps’s race against the great white shark on the Discovery channel, there are some entrepreneurs who are quietly preparing to go head to head with a different group of sharks in the upcoming season of ABC’s Shark Tank which is scheduled to return in the fall.
The program, which debuted in 2009, is viewed by 4 to 5 million people per episode. During the show, entrepreneurs pitch their company or product idea to a panel of potential investors—aka: “sharks”. Last year, the “sharks” invested about $12 million in winning entrepreneurs.
As importantly, entrepreneurs are able to pitch their products to a massive national audience. Considering that an estimated 80% of American adults experience back pain at least once in their life, this could be more valuable to a young spine company than even the Shark money.
Paul Leake, CEO and managing director of VerteCore Technologies, LLC, one of the inventors of the VerteCore Lift, recently went to open auditions for the Emmy Award-winning reality show at Xfinity Live in Philadelphia, Pennsylvania, and talked to OTW about the experience.

Courtesy of Paul Leake, co-founder of VerteCore Technologies

The Lift
The VerteCore Lift is a Class 1, FDA- cleared medical device that can treat many different types of back pain caused by bulging discs, herniated discs, degenerative disc disease, pinched nerves, sciatica, sacroiliac joint dysfunction, idiopathic scoliosis, and spinal lumbar stenosis. It works by decompressing the intervertebral discs which relieves pressure being placed on the spinal

nerve column and helps the body heal naturally without surgery or pain medication.
According to Leake, the spinal decompression allows the herniated material to be reabsorbed into the proper position. Patients can use the Lift at home but physicians can also keep one in their office for their patients to use during office visits. Typically, patients wear the device once or twice a day for 20 minutes.

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“The Lift is more convenient and comfortable than an inversion table. You don’t have to hang upside down like a bat and there are not as many contraindications like hypertension, obesity, hip or knee pathology and glaucoma,” he said.
“Consider also all that extra time and money you save from no longer having to travel to a spinal decompression clinic a couple times a week.”
Leake added though that they do have a screening process for the device and not everyone with back pain is the ideal candidate. Patients with hardware in their back after a spinal fusion for instance are not good candidates for the Lift.
The Back Story
The inspiration for this device came from Leake’s and his co-founder Paul Montalvo’s own personal struggles with chronic back pain. Montalvo, chief design officer for the company hurt his back during a competitive motocross race more than 10 years ago and surgeons told him he was not a good candidate for surgical intervention even though he was in constant pain.
Leake first injured his back while serving as a specialist in the U.S. Army and as a helicopter crew chief in the U.S. Army National Guard about 15 years ago, and since then has suffered repetitive injuries and chronic pain.
After years of trying to find a device or a medicine to alleviate their pain, Leake and Montalvo decided to create their own solution. Both have personally found successful pain relief by using the Lift and Leake says that a decompression session with the device will last him at least two to three days

or up to two to three weeks if he is not doing any strenuous activity.
To help raise money to fund the production of the device, VerteCore Technologies held an Indiegogo Crowdfunding Campaign last summer where they raised $421,545 and garnered the interest of MedTech Innovator, a nonprofit global competition and accelerator for medical device, digital health and diagnostic companies.
“They look for new innovative products for the healthcare community that they feel could elevate a patient-centric approach and help these companies get exposure or funding and fine-tune their product value going forward,” Leake said.
“We went to one of their pitch events in March and we happened to win the event. It was an amazing experience. Basically, you go in and you literally give a 1-minute pitch, just kind of a rapid-fire definition of what your product is and whatyourproductvalueisandwhatkind of benefit it will bring to the healthcare community and patients,” he said.
VerteCore was also invited to participate in MedTech Innovator’s 2017 accelerator program.
“We went to San Francisco for the kickoff event earlier in June and attended the Wilson Sonsini Medical Device Conference where we networked with industry professionals as well as some venture capitalists. We got some real exposure to people who are like-minded and who want to take a more patient-centric approach to healthcare,” Leake said.
The Road to Shark Tank
So, what led Leake to try out for Shark Tank? Leake said that early in

the development of the device people kept telling them they should be on the show because their product is a novel idea.
“It has a wow factor that is kind of hard to describe, but when you strap on one of our units on, you can feel it work, you can actually see it work as it is correcting posture, unloading the spine,” he said.
“You can also hear it work because of our ratcheting mechanism that actually facilitates the decompression. So, whether you are watching someone use the device or you are trying it on especially for the first time, it is like ‘Oh, my God,’ I can see it work. I can feel it work.’ That is incredible,” he added.
Leake said that he and Montalvo kept this in the back of their minds as they were developing their product. Then a producer from Steve Harvey’s FUNDERDOME, which also airs on ABC and has a similar premise to Shark Tank, reached out to them after their Indiegogo Crowdfunding Campaign went so well.
“This brought us back around to the concept that this does really have great curb appeal to it so maybe we should really look at Shark Tank and some of these shows for the exposure if nothing else,” Leake said.
The Audition
Leake approached Shark Tank two ways, first by submitting an online application and then to hedge his bets by attending one of their open casting auditions.
The application, Leake said, is a 17- page document that essentially details

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what your premise is, why you think you would be a good fit for Shark Tank and which shark do you think you would have the most conducive relationship with and why. You must also give specific information about your product and company.
Leake told OTW that the actual open call was a very long process. When the doors opened at 9 a.m. there were already 500 people in line with more people showing up as the day progressed; so, while initially the one on one pitches were meant to be 10 minutes, in the interest of time by the time Leake got in front of a producer around 4 or 5 p.m., he had only five minutes for his initial pitch.
“There was a lot of entrepreneurs and would be entrepreneurs that had their ideas that they wanted to put forward. And it was everything from concepts that were sketched out on whiteboards to finished products,” he said.
“While you were waiting your turn in the tank you can network and speak freely with the other entrepreneurs so a lot of people were taking that opportunity to try out their pitches on one another and get some critiques so they could fine-tune their pitches before getting in with the producers,” he added.
During his pitch, Leake said he emphasized the large number of people suffering from back pain today and how a lot of these conditions can be treated or mitigated through decompression therapy. Besides those patients who are told they are not a good candidate for surgical intervention, there are also patients who have failed back surgery syndrome, a term used to describe

when surgery is not successful in alleviating chronic back pain. He cited a 2010 study published in the journal Spine that found that 74% of back surgeries fail.
“Only about 5% of patients with back pain are ideal candidates for surgery but the way our healthcare system is set up, it pushes a great deal of people toward surgical intervention,” he told us later in the interview.
“Everyone wants pain relief, everyone wants their problems fixed, but it’s gotten to the point that we have this instant gratification mindset that makes us think that surgery will get us immediate results and unfortunately there are a lot of medical professionals who have the same mindset.
“And they could be the greatest surgeon in the world, but if surgical intervention is not timed properly or isn’t within the ideal candidate framework, it is just going to add to the statistics of failed back surgery,” he said.
“It is a real shame that it has gotten to this point because in our country unfortunately, there is such a growing opioid epidemic and a percentage of these individuals actually started with chronic back pain. With our device patients are able to move without pain which helps eliminate the need for opioids.”
During the pitch, Leake also strapped on the device to demonstrate how it works which peaked the producer’s interest.
“The effect of watching the Lift being demonstrated for the first time is universal. As they are hearing and
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seeing it work, everyone’s eyes widen a bit and they are like, ‘Wow!’ The agents and producers I met with were the same way,” he said.
Leake also shared his own struggle with back pain and how it compelled him and Montalvo to bring the device to market.
Once his pitch was done he was asked a series of questions not unlike those that the sharks would ask including projective sales numbers, business model and the size of the market for the product.
“I was also asked about the efficacy of the device and who would benefit from the device. I kept getting the feeling and statistically speaking this would have to be true that the producer had a family member who suffered from back pain,” he said.
After his initial pitch, Leake was also approached by other casting agents or producers who asked him more questions.
“Our story really seemed to resonate with the producers. People don’t understand the true power of effective decompressio. We have already helped so many people and it has been an amazing journey so far.”
Since the open audition VerteCore Technologies, LLC, has been contacted by Shark Tank. Moving forward they will be in a media blackout as they continue through the application process. ♦

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Why are surgeons reluctant to perform total disc replacements?

RE: TDR, IT’S OBJECTIVE REALITY VS. SUBJECTIVE OPINION (Orthopedics This Week)

A curious researcher from Croatia has dug into 80 studies to uncover some of the reasons spine and neuro surgeons are occasionally reluctant to perform a total disc replacement (TDR). The study, “Failure of lumbar disc surgery: management by fusion or arthroplasty?” appears in the November 13, 2018 edition of International Orthopaedics. 

Dr. Vladimir Kovač, with the Arithera Hospital for Special Diseases in Zagreb and author of the study, explained his research to OTW, “I am a spine surgeon, and besides other pathologies I perform disc arthroplasties. I am satisfied with my results. However, there are a lot of controversies in this procedure, and numerous colleagues are against this procedure. My personal interest was to find out what is objective in these pro- and con- arguments.”

Dr. Kovačfound that issueswith anterior surgery, reimbursement policy, and potential problems with salvage surgery are major reasons for the decline in TDRs.

Dr. Kovačcommented to OTW, “For me the most important information was that we avoid objectively better surgery, because of subjective reasons (for example insufficient competence in anterior surgery).”

“Nobody thinks about turning back to hip fusions, because there are complications and problems in hip arthroplasty. So hip arthroplasty is improving on and on. For me, spine fusions have reached the top of further improvement (there are no further significant improvements possible).”

“Disc arthroplasty is still at the beginning. It is a demanding surgery, but I am convinced that a lot of surgical and constructional improvements can be done. I believe there is no way to go backwards. Despite that it can be difficult, it seems to me that the only way is to solve the problems and move forward.”

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