Stryker launches expensive Mako robot for knee replacement in cost-conscious era

Posted On March 15, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

As value-based care and bundled payments begin to take hold in the orthopedics industry and healthcare overall, Kalamazoo, Michigan-based Stryker is doing something counterintuitive.

It is launching an expensive piece of equipment. Coinciding with the first day of the annual meeting of the American Academy of Orthopaedics Surgeons (AAOS) in San Diego, the orthopedics company announced Tuesday that the MAKO robot is now officially launched in the U.S. to perform total knee replacements. (MAKO has been available to perform total hip knee replacements and partial knees in the U.S. up until now.)

Why introduce a reportedly million-dollar piece of new technology at a time when hospitals and orthopedics practices are racing to reduce the cost of hip and knee replacements?

In a phone interview, Stuart Simpson, vice president and general manager, Stryker, shared his confidence that the Mako robot with the total knee application would have both clinical and economic benefits that hospitals would find compelling.

To step back a bit, Stryker made a bold acquisition of Mako for nearly $1.65 billion in 2013. Bold because none of the larger ortho players had envisioned joint replacement procedures to be done by a robot. The company has also bucked the consolidation trend in the marketplace – think Zimmer buying Biomet; Wright Medical buying Tornier – although there leaked reports showed that it was exploring a merger with Smith & Nephew. The bet was new, innovative technology backed by proper clinical and economic validation would win the future.

Mako’s total knee application — where the Mako robot would implant Stryker’s Triathlon knee — won FDA approval back in August 2015. But Kevin Lobo, the company’s CEO made the rather atypical decision to delay a wide sales roll out nationwide until 2017. [ I reported on that decision for a different publication last year].

In that two years, Mako’s total knee application has been used on a limited basis in 65 hospitals in the U.S., U.K., Japan and Germany, Simpson said and more than 1,400 cases have been performed.

Now it’s ready for full launch and the hope is that the clinical benefits noticed in the partial knee application by using the Mako robot will extend to the total knee as well.

READ THE REST HERE

Rotation Medical Bioinductive Implant Induces New Tissue Formation in Patients with Large and Massive Rotator Cuff Tears

Posted On March 15, 2017 By OrthoSpineNews In Sports Medicine /

March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced results of the first study of the company’s collagen-based Bioinductive Implant on patients with large and massive rotator cuff tears. The results, which were presented at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego, showed the Bioinductive Implant induced new tissue formation in all study participants.

“Failure of large and revision rotator cuff repairs continues to be a challenging problem,” said Felix H. “Buddy” Savoie, MD, study investigator and chairman of the Department of Orthopedics at Tulane University School of Medicine in New Orleans. “This study is exciting for the field of rotator cuff repair, as it showed that the Bioinductive Implant induces new tissue formation and assists in healing for patients with large and massive rotator cuff tears.”

The study enrolled 23 patients – 11 with large (two tendon) and 12 with massive (three tendon) rotator cuff tears – 16 of whom had previous rotator cuff repairs. All patients received the Rotation Medical Bioinductive Implant via arthroscopic surgery. New tissue formation was observed in all 23 patients, and 22 successfully healed their rotator cuffs. Postoperative ultrasound was used to assess tendon thickness at three, six and 12 months, and MRIs were taken at six and 12 months to confirm healing and tendon thickness. Rotator cuff thickness ranged from 5-9 mm at most recent follow-up, and all clinical scores improved significantly over time.

“Results of this study are consistent with the biopsy study published last month in Arthroscopy showing that our Bioinductive Implant promotes the growth of tendon-like tissue,” said Martha Shadan, president and CEO of Rotation Medical. “There is a growing body of evidence demonstrating that the Rotation Medical Rotator cuff system has the potential to transform the treatment of rotator cuff disease by addressing both the biomechanics and biology required to heal a rotator cuff tendon tear.”

The study, “Preliminary Investigation of a Bio-Inductive Collagen Patch used on Large/Massive Rotator Cuff Tears,” adds to the growing body of literature supporting the use of the Bioinductive Implant as a novel and effective treatment for rotator cuff tears. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.

For important safety information, visit http://rotationmedical.com/our-solution/risks/.

Rotation Medical is also exhibiting at the meeting in Booth #5916.

About Rotator Cuff Tears

Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.

About the Rotation Medical Bioinductive Implant

Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address this limitation by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.

About Rotation Medical

Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit www.rotationmedical.com.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Gary Henley Joins Spinal Simplicity, LLC as an Advisor and to Serve on the Board of Managers

Posted On March 15, 2017 By OrthoSpineNews In Spine /

OVERLAND PARK, KANSAS (PRWEB) MARCH 14, 2017

Spinal Simplicity, a medical device company developing innovative solutions to treat complex spinal and orthopedic surgical problems, announces Gary Henley has agreed to serve as an Advisor and will join the Company’s Board of Managers.

Gary Henley is an accomplished medical device executive with over 34 years of experience in the orthopedic industry. Most recently, Mr. Henley served as President, Chief Executive Officer and Board Member of United Orthopedic Group from 2011 to 2014. Prior to United Orthopedic Group, Mr. Henley served as President and Chief Executive Officer of Wright Medical Group, Inc. from 2006 to 2011. Mr. Henley also spent nine years at Orthofix International N.V. as President of its Americas Division from 1997 through 2006. Early in his career, Mr. Henley successfully created Cecorp, Inc., a surgical visualization pioneer in the arthroscopic and endoscopic markets and then sold the company to Smith & Nephew. After the sale in 1987, Mr. Henley served as President of Smith & Nephew’s Endoscopy Video Division until 1996. Mr. Henley has significant board experience, including Board Chairman of OrthoAlign, with similar roles at Orchid Orthopedic Solutions, Hutchinson Technology, Wright Medical Group, Innovative Spinal Technologies, and BioFuse Medical.

Todd Moseley, CEO of Spinal Simplicity said, “Gary’s decision to join Spinal Simplicity [as an Advisor and Member of our Board of Managers] reinforces our position that our innovative technology in the orthopedic and spine markets will bring about sweeping enhancements to the treatment options available to patients. Gary has successfully orchestrated transactions and built critical mass within companies that have dominated the spinal and orthopedic markets. Spinal Simplicity will benefit greatly from the industry expertise and healthcare-related innovations that have been the hallmark of Gary’s career. The fact that we can tap into Gary’s experience as we bring the Minuteman® G3-R to the minimally-invasive spine market will truly change the landscape of posterior supplemental fusion and fixation. Equally critical is the fact that Gary’s expertise in the extremities space will be invaluable to the company during development of the Wolff’s LawTM plating technology.”

Mr. Henley added, “I am excited about joining Spinal Simplicity’s Board. I think they have some very compelling technology in their products that will bring better clinical outcomes for patients, while also reducing the cost of doing certain procedures. It is going to be fun being part of the team that is bringing these innovative products to market.”

Spinal Simplicity’s Minuteman® family of sterile packed, posterior, non-pedicle supplemental fusion and fixation devices for use in the non-cervical spine (T1-S1) provide an alternative to traditional fixation, such as pedicle screws. The Minuteman® family of devices consists of a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor.

Spinal Simplicity will be exhibiting at the 2017 American Academy of Orthopaedic Surgeons meeting in San Diego, booth 659.

About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of simple solutions for the treatment of complex spinal and orthopedic problems. Spinal Simplicity has regulatory clearance for the Minuteman® system in the US, Europe and Canada. Our vision is to be the global leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com

DJO Global Announces FDA 510(k) Clearance for Exprt® Revision Hip

Posted On March 15, 2017 By OrthoSpineNews In Regulatory /

March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced that its Exprt® Revision Hip portfolio received market clearance by the U.S. Food and Drug Administration. Exprt® Revision Hip is the latest addition to DJO Global’s Exprt® portfolio – a platform defying conventional approaches to total joint implants by improving outdated designs, focusing on patient outcomes and reinventing traditional price points.

The 12,000 surgeons expected to attend this year’s Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS booth #1733) in San Diego, CA will have an opportunity to preview the full-line, modular femoral stem inspired by the clinical success of Wagner-style predecessors. The system’s intuitive design and premium quality is based on extensive research and development that redefines revision total hip arthroplasty by offering an anatomically inspired design that has an emphasis on efficiency and strength – all for 40-70% of the price of comparable revision hip systems.

“One of the biggest challenges our healthcare system encounters is introducing modern technologies at increased price points. The latest addition to the Exprt portfolio signifies our deep commitment to not only clinical outcomes, but both surgical and cost efficiencies,” said Mark Russell, Senior Vice President of the Surgical division of DJO Global.

The two-tray revision system represents an 80-90% reduction in instruments compared to competitive systems. Streamlined instrumentation translates into less money and time spent on sterilization, less overall time in the operating suite, and less storage space – appropriate for both hospital and ASC settings.

Exprt Revision Hip was developed in partnership with industry leading physicians. Michael Taunton, M.D. at the Mayo Clinic and design team member of the Exprt Platform was one of the first surgeons to implant the device. “Having a thoughtful approach to introducing new technology in today’s healthcare landscape will drive shifts in the market place. We designed DJO Global’s Exprt Revision Hip and Knee Systems to challenge conventional approaches to revision arthroplasty. These systems allow me to do what I used to think wasn’t possible – treat my patients with a high-quality implant with improved surgical efficiency and reproducible outcomes while simultaneously being economically responsible.”

For more information on the Exprt portfolio – including Revision Hip and Knee – please visit: www.exprtprecision.com

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for the success of the Exprt® product portfolio. The words “believe,” “will,” “should,” “expect,” ”target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause the results of the Exprt Hip products and other Exprt portfolio products to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the complexities and uncertainties associated with the development of new products; the uncertainties associated with acceptance of the new products by surgeons and patients; new product introduction and other business strategies relative to our Surgical Implant segment; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 25, 2016. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
760-734-3075
ir@djoglobal.com

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DonJoy Revolutionizes Osteoarthritis Bracing with Introduction of “TriFit” Knee Brace

Posted On March 15, 2017 By OrthoSpineNews In Extremities /

March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, today launched OA Reaction TriFit™ Knee brace from DonJoy – the company’s latest OA knee brace designed to provide much needed pain relief to those who suffer from the incurable, degenerative joint disease that affects more than 11 million¹Americans. TriFit, from DonJoy, is designed to provide pain relief to individuals who suffer from moderate to severe Knee OA caused from an active lifestyle (overuse), suffer from excess body weight (obesity) or who are suffering from the effects of aging.

The most common type of arthritis, Knee OA, occurs when the cartilage which provides cushioning within the joints, wears down over time, resulting in bone-on-bone rubbing, which causes stiffness, pain, swelling, decreased mobility and bone spurs. OA is a condition that develops slowly, yet can become increasingly worse over time and may result in additional medical issues such as diabetes, heart disease and vascular problems if not addressed in its early stages. The knee is commonly affected by OA at a cost of $128 billion² to healthcare.

“With more than 40 percent of knee replacements occurring in patients over the age of 65 and the average onset of knee OA occurring at the age of 55³, there is an inherent need for non-invasive, non-addictive methods to control pain and to support maintaining an active lifestyle,” said Steve Ingel, President of Bracing & Supports at DJO Global. “With the onset of knee pain people tend to reduce their activity levels when the most important thing they can do to slow the progression of the disease is to remain active. Fortunately, the advanced low profile comfort of TriFit, provides a solution that aids in pain relief and helps keep patients moving.”

TriFit by DonJoy features three unique technologies that together provide a custom fit to allow OA sufferers to move freely without pain so they can participate in light to heavy activities.

Web Tech™ is a shock absorber that assists with full knee extension and patellofemoral (PF) tracking
Exos® Tech provides a heat thermoformable custom fit that hugs perfectly around the knee (thigh and the shin or above and below the knee)
Boa® Tech uses a micro tension adjustment system that pulls everything together and provides three-dimensional protection

When compared to non-treatment, active use of bracing such as TriFit can slow the progression of Knee OA or other serious knee injuries enabling ongoing activity.

To learn more about your bracing options or to order TriFit, contact your general physician. To see all of DonJoy’s new technologies visit www.djoglobal.com

Individual results may vary.

Neither DJO Global, Inc. nor any of its subsidiaries dispense medical advice. The contents of this press release do not constitute medical, legal, or any other type of professional advice. Information related to various health, medical, and fitness conditions and their treatment is not meant to be a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF^TM, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and Exos^TM. For additional information on the Company, please visit www.DJOglobal.com.

Social Media:

Facebook: /donjoy

Twitter: @donjoy

References:

Contacts

Chloe Canta (The Brand Amp)
chloe@thebrandamp.com
949.438.1083

Nearly all shoulder replacement patients under age 55 return to sports

Posted On March 14, 2017 By OrthoSpineNews In Recon /

SAN DIEGO, Calif., March 14, 2017 /PRNewswire-USNewswire/ — A new study being presented today at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS), found that 96.4 percent of recreational athletes, age 55 and younger, who underwent total shoulder replacement surgery returned to at least one sport, on average, within seven months of surgery.

Today, about 53,000 people in the U.S. have shoulder replacement surgery each year, according to the U.S. Agency for Healthcare Research and Quality. This compares to more than 900,000 Americans a year who have hip and knee replacement surgery. In shoulder replacement surgery, the damaged parts of the shoulder are removed and replaced with artificial components, called a prosthesis. A total shoulder replacement involves replacing the arthritic joint surfaces with a highly polished metal ball attached to a stem, and a plastic socket.

In younger patients, repetitive movements required in various sporting activities can cause early osteoarthritis, or wear and tear of the joint, resulting in the need for a replacement.

In this study, researchers conducted a retrospective review of 61 patients who underwent a total shoulder replacement. The average age at the time of surgery was 48.9 years (ages 25 to 55), of which most of the shoulder damage (80.3 percent) was caused by osteoarthritis. Nearly 68 percent of patients said they hoped to return to sports following surgery.

Among the study highlights:

Ninety-three percent of patients were satisfied with the outcomes of their surgery, and 96.4 percent (55 out of 57 patients) returned to at least one sport at an average of 6.7 months following surgery.
The direct rates of return to sports included: fitness sports (97.2 percent), golf (93.3 percent), singles tennis (87.5 percent), swimming (87.5 percent), basketball (75 percent) and flag football (66.7 percent).
More than 90 percent of patients returned to a high-demand sport and 83.8 percent returned to a sport that required high use of the arms and shoulders.
There was no significant difference in the rate of return to sport by body mass index, sex, age, preoperative diagnosis, revision status and/or dominant extremity.

“Our results evaluated patients at an average of five years of follow up and most patients continued to be very satisfied and performed a high number of sporting activities, including those that required high use of their shoulders,” said study author Grant Garcia, MD, an orthopaedic surgeon at the Hospital for Special Surgery (HSS) in New York. “This information is important as it demonstrates that total shoulder arthroplasty may be a good option in younger patients who are indicated for a shoulder replacement.”

The study, “High satisfaction and return to sports after total shoulder arthroplasty: age 55 and younger,” appeared in the Sept. 28, 2016 issue of the World Journal of Orthopaedics.

Study abstract

2017 AAOS Annual Meeting Disclosure Statements

The American Academy of Orthopaedic Surgeons
With more than 39,000 members, the American Academy of Orthopaedic Surgeons (AAOS) is the world’s largest association of musculoskeletal specialists. The AAOS provides education programs for orthopaedic surgeons and allied health professionals, champions and advances the highest musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments, and related issues.

Visit AAOS at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
Facebook.com/AAOS1
Twitter.com/AAOS1

CONTACT: Sheryl Cash, 847-384-4032, 847-804-7486, scash@aaos.org | Lauren Pearson Riley, 847-384-4031, 708-227-1773, pearson@aaos.org

This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

High rate of return to running following arthroscopic hip surgery

Posted On March 14, 2017 By OrthoSpineNews In Sports Medicine /

SAN DIEGO, March 14, 2017 /PRNewswire-USNewswire/ — Ninety-six percent of patients who were recreational or competitive runners prior to developing hip bone spurs returned to their sport within nine months of arthroscopic surgery, according to research presented today at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

Bones spurs on the hip joint, or femoracetabular impingement (FAI), is a common condition in which there is extra growth along the bones, giving the bones an irregular shape and causing them to rub together during movement. Over time, the friction can damage the soft tissue surrounding the hip joint causing pain or a limp, which limits activity. Arthroscopic hip surgery is a minimally invasive procedure during which a small camera, called an arthroscope, is inserted into the hip joint guiding the surgeon to remove the bone growths.

In the study, researchers retrospectively reviewed the records of 51 FAI patients (23 men and 28 women) who had undergone hip arthroscopy and identified themselves as recreational or competitive runners. Patient outcomes two years after arthroscopy were assessed using a running-specific questionnaire and common outcome and activity measurements.

The average age of patients was 27 years, and body mass index (BMI) was 24 kg/m² (a patient with a BMI greater than 25 is considered overweight). Prior to surgery, patients had stopped running because of FAI pain for an average of 9 months.

Among the results:

After surgery, 49 patients (96 percent) returned to running at an average of 9 months after surgery.
Increasing BMI was associated with a slower return to running.
Patients who had stopped running for greater than eight months prior to hip arthroscopy returned to running significantly more slowly than those who had stopped running closer to surgery.
After two years, the mean running distance of patients had decreased significantly from an average of 10 miles per week to 6 miles.
Patient outcome and activity scores all improved significantly for patients after surgery, with females showing greater progress than males.

“Arthroscopy is a minimally invasive and effective treatment for FAI in runners,” said David M. Levy, MD, lead author of the study and an orthopaedic surgeon at Rush University Medical Center in Chicago.

“High Rate of Return to Running” appeared online Sept. 12, 2016 in the American Journal of Sports Medicine.

Study abstract

2017 AAOS Annual Meeting Disclosure Statements

CONTACT: Sheryl Cash, 847-384-4032, 847-804-7486, scash@aaos.org, or Lauren Pearson Riley, 847-384-4031, 708-227-1773, pearson@aaos.org

This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

Nearly one-third of osteoarthritis-related costs incurred the year prior to knee replacement surgery are for non-recommended treatments

Posted On March 14, 2017 By OrthoSpineNews In Recon, Top Stories /

SAN DIEGO, March 14, 2017 /PRNewswire-USNewswire/ — In the year prior to total knee replacement (TKR) surgery, almost one-third of the costs for treatment of arthritis symptoms went toward strategies not recommended by the American Academy of Orthopaedic Surgeons (AAOS), according to new research presented today at the 2017 AAOS Annual Meeting. Costs could decrease by an estimated 30 percent if treatments that are not recommended are no longer utilized.

“As we transition to an era of value based health care, it will be important to consider both the quality of our interventions as well as the cost associated with that care,” said study author Nicholas Bedard, MD, an orthopaedic surgeon at the University of Iowa Hospitals & Clinics.

Researchers reviewed Humana Inc. insurance information (both private and Medicare Advantage plans) from 2007 through 2015 on more than 86,000 patients diagnosed with osteoarthritis of the knee, who went on to have TKR within one year. The costs were specifically related to reimbursement for hyaluronic acid (HA) or corticosteroid (CS) injections, physical therapy (PT), braces and wedge insoles, pain medication and non-steroidal anti-inflammatory drugs (NSAIDs). Only three of these treatments—physical therapy, NSAIDs, and the drug tramadol (short-term for severe pain)—are recommended in the AAOS clinical practice guideline (CPG): “Non-arthroplasty Treatment of Osteoarthritis of the Knee.”

The total costs associated with outpatient knee osteoarthritis was $43,582,648. Among the other findings:

65.8 percent of the patients (56,960) underwent at least one of the analyzed treatments in the year prior to their TKR.
The top three most costly treatments were HA injections, CS injections and PT, accounting for 52.6 percent of expenses (excluding hospital or inpatient), total costs of knee osteoarthritis in the year prior to TKR.
The AAOS recommended treatments—PT, NSAIDs and Tramadol—represented just 11 percent of the total costs; in contrast, 29 percent of the costs were for interventions with strong or moderate recommendations against their use in the AAOS knee CPG.

“We hope that research such as this highlights the high prevalence of low-value interventions in the management of knee osteoarthritis and helps to motivate a transition to higher value care,” said Dr. Bedard.

Study abstract

2017 AAOS Annual Meeting Disclosure Statements

CONTACT: Sheryl Cash, 847-384-4032, 847-804-7486, scash@aaos.org; or Lauren Pearson Riley, 847-384-4031, 708-227-1773, pearson@aaos.org
This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

$Despite the known role of vitamin D in preventing osteoporosis, less than half of elderly hip fracture patients take supplements$

Despite the known role of vitamin D in preventing osteoporosis, less than half of elderly hip fracture patients take supplements

Posted On March 14, 2017 By OrthoSpineNews In Extremities, Spine /

SAN DIEGO, Calif., March 14, 2017 /PRNewswire-USNewswire/ — Despite national recommendations for daily vitamin D intake, a new study presented today at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that just 45.7 percent of patients reported consistently taking vitamin D supplements following a hip fracture, a known treatment and preventative strategy for osteoporosis.

In the U.S., an estimated 44 million people have osteoporosis and another 10 million are at risk for the disease which causes progressive bone loss and increased fracture risk. One in two women and one in four men older than age 50 years will sustain a bone fracture caused by osteoporosis. These potentially debilitating injuries include fractures of the hip, spine, wrist, arm or leg, often occurring from a fall. A bone fracture is often the first sign of the disease which develops slowly with no other symptoms. Treatments, which include medication, weight-bearing exercise, and/or vitamin D, calcium or estrogen supplements, can prevent subsequent fractures.

The U.S. Food and Nutrition Board (FNB) at the Institute of Medicine of The National Academies recommends 600 International Units (IUs) of vitamin D each day for adults, and 800 IUs for Americans age 71 and older.

In this study, Canadian researchers interviewed 573 hip fracture patients about their vitamin D intake during doctor visits for two years following hip fracture surgery. The mean patient age was 74.1, and the majority of patients (66.3 percent) were women.

Less than 50 percent (47.5 percent) of the patients consistently took vitamin D supplements as recommended, 35.6 percent took supplements inconsistently, and less than 19 percent took no supplements. Despite well-developed guidelines and close follow-up in a clinical trial, a low proportion of elderly hip fracture patients are consistently taking vitamin D. This suggests a need to develop and evaluate additional strategies to promote compliance.

“Vitamin D supplementation following hip fracture surgery is grossly under-prescribed,” said co-study author Mohit Bhandari, MD, an orthopaedic surgeon and research chair in musculoskeletal trauma and surgical outcomes, at McMaster University in Ontario, Canada. “Given its potential to improve patient function independent of other therapies, it seems improved advocacy and education—aimed at doctors and patients—about vitamin D supplementation is both worthwhile and evidence-based.”

Added co-study author Earl Bogoch, MD, an orthopaedic surgeon at the University of Toronto: “The benefits, safety and ease of taking vitamin D appear to be unknown or ignored by this representative cohort group of elderly osteoporotic patients who are identified by numerous guidelines as being most likely to benefit.”

The AAOS position statement, “Orthopaedic Care of Patients with Fragility Fractures,” recommends that U.S. physicians proactively screen, monitor, and, if necessary, assist in getting treatment for elderly and other at-risk patients for osteoporosis following an initial bone fracture to prevent subsequent fractures.

Study abstract

2017 AAOS Annual Meeting Disclosure Statements

This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

SpineGuard and Zavation Announce First 20 Cases in USA with Single-Step Insertion of DSG™ “SmartScrew”

Posted On March 14, 2017 By OrthoSpineNews In Spine /

March 14, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today the first cases in the USA using the one-step-insertion of pedicle “smart screws” guided by DSG™ (Dynamic Surgical Guidance) technology. The surgeries were performed successfully by eminent surgeons throughout the USA.

See 3D animation of the “SmartScrew” here.

Thomas Freeman, Professor of Neurosurgery, Tampa, Fla., said: “I knew immediately where the trajectory of the screw was going, even without fluoroscopy. Rather than use five steps to put a screw into the spine, only one step was needed. I could redirect it easily if needed.”

“The DSG technology will change the way spine surgery is performed. It will allow us to place spinal instrumentation faster, safer and with greater accuracy minimizing the risks to our patients,” said Victor Hayes, MD, Orthopedic Surgeon, Trinity Spine Center, Tampa, Fla.

“Integrating the Dynamic Surgical Guidance technology with pedicle screws will greatly optimize the workflow and accuracy, and reduce radiation exposure for surgeons in both the traditional and MIS surgical settings. Not only will the ‘smart screw’ allow for active real-time guidance and breach-avoidance through the pedicle, but it will also provide unprecedented feedback and confidence in the ultimate fixation of the screw itself,” said Larry Khoo, MD, neurosurgeon at The Spine Clinic, Los Angeles, Calif.

“The procedures that we have performed with the self-guiding ‘Smart Screw’ technology have advanced the safety of spinal surgery exponentially by reducing the probability of nerve and spinal cord injury and reducing radiation exposure to patients and hospital staff,”added Farhan Siddiqi, MD, Assistant Professor, University of South Florida, Trinity Spine Center, Florida Advanced Spine, Sports, and Trauma Centers.

John I. Williams, MD, SpineONE, a division of Ortho NorthEast, Ft. Wayne, Ind., concluded: “One-step technology is something that is being explored by multiple implant manufacturers right now…. this ‘smart screw’ with DSG technology is simply going to remove several steps in the process of applying spinal instrumentation.”

For SpineGuard and Zavation, who announced their co-development partnership in early 2015, these successful first surgeries performed after obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA) are an essential milestone in preparation for the commercial launch of the Zavation pedicle screw instrumentation that integrates the DSG technology.

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “These surgeries further validate the clinical utility of embedding our DSG technology into the vertebral implant itself, thus enabling its insertion without any preliminary step. We are steadfast in the concept that DSG technology will further secure and simplify the most commonly performed instrumented spine procedure, fusion, while optimizing its cost to the hospital with an ‘integrated guidance’ approach.”

Jeffrey Johnson, CEO and founder of Zavation, added: “Early surgery results with our Z-Direct Screw combined with the DSG technology have been very successful. The single-step technology allows surgeons to use less fluoroscopy and reduce surgery times with excellent screw placement.”

Pedicle screw-based fusion has become the gold standard for treating spine instabilities and deformities. The US spine industry is estimated to have grown 5% between 2015 and 2016 to $7.8 billion in sales to US hospitalsⁱ. This is the highest year-to-year growth in this market since 2010, and reflects the growth in specific sub-segments of the spine market. The US market for spinal implants and devices used in spinal surgery now exceed both the size and growth of the US hip and knee market which was estimated to be $7.5 billion in 2015, up 2.5% from 2014.

More information on the DSG™ technology, its new applications and surgeons’ testimonials here.

More information on the Zavation products that incorporate DSG™ technology click here.

Previous release: SpineGuard extends the utility of its Dynamic Surgical Guidance (DSG ™) technology platform by receiving US patent for “Bone Quality Measurement” application.

Next Press Release: 2016 Full-Year financial results, March 23, 2017

SpineGuard will participate in the ‘Canaccord Genuity Musculoskeletal Conference’ conference on March 14^th, 2017 in San Diego, CA before the American Academy of Orthopedic Surgeons Annual Meeting.

About SpineGuard^®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard^®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About Zavation
Zavation is an employee-owned medical device company that designs, develops, manufactures and distributes medical device products that provide comprehensive medical solutions to improve and enhance quality of life for patients around the world. Zavation is dedicated to exceeding expectations in product quality, customer service, and product cost. For further information, visit www.zavation.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any USA state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

ⁱSource: Orthopedic Network News, 2016 Spinal Surgery Update, Volume 27, Number 4; October 2016.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Zavation
Jeffrey Johnson, 601-919-1119
Chief Executive Officer
Jeffrey.johnson@zavation.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Month: March 2017

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