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After a patient has been fitted with an artificial hip joint, sometimes the leg on that side ends up longer or shorter than before. This can lead to problems in the spinal column. A newly developed procedure enables leg length to be precisely adjusted during hip replacement surgery.

The modular hip implant allows the femoral stem and acetabular cup to be adapted to each individual patient. (Image: © Fraunhofer IWU)

Today hip replacement is a routine surgical procedure. Some 210,000 hip prostheses are implanted every year in Germany. A frequent complication consists of the situation that, after the operation, the patient’s leg is not the same length as it was before. Normally, a leg length discrepancy of less than one centimeter is well tolerated. Any more, and the patient will most likely have to wear orthopaedical shoe lifts to compensate for postural imbalance and prevent back pain.

Fraunhofer Institute for Machine Tools and Forming Technology IWU, together with partners in science and industry, has found a solution to this problem. “It consists of three main components: an optical system to measure leg length, a modular implant design, and a pre-op planning software tool,” says Dr. Ronny Grunert from the institute’s Department for Medical Engineering.

The leg length is measured in the operating room just prior to surgery. First, a plastic box with optical markers on its surface is attached to the patient’s tibia. Holding the limb in extension, the surgeon then takes the leg by the heel and lifts it upward. During this maneuver, a 3D camera is used to record the circular motion described by the optical markers on the patient’s shin. In essence, it’s like using a mathematical compass to draw circles around a point, which in this case is the hip joint around which the leg rotates. In this analogy, the optical markers correspond to the tip of the pencil. After provisionally inserting the implant, a second measurement is carried out. The software program compares the two rotational measurements to verify that the leg length remains the same before and after the intervention. If a difference is detected, the length inequality must be corrected.

Free choice of femoral stem and acetabular cup

“Together with our partners, we have developed a modular concept that allows the size and position of the artificial hip joint to be optimized for each patient during surgery,” explains Grunert. This modular approach is more flexible than having to choose between prefabricated implants in a limited range of sizes. It allows the surgeon to select the best-fitting combination of femoral stem and acetabular cup. The procedure consists of implanting the femoral stem and connecting it with the acetabular cup by means of a sliding screw. By adjusting the position of the screw, it is possible to precisely adjust the leg length according to the pre-op measurement. If necessary, a different acetabular cup can be selected.

The third component of the new procedure, the pre-op planning software, helps the physician to select the most suitable prosthetic joint. Dr. Torsten Prietzel, Medical Director of the Endoprosthetics Network and Chief Surgeon at the Helios Clinic in Blankenhain, is already using the software on a trial basis. The modular implants and the system for measuring leg length are also still in the test phase. Ronny Grunert estimates that all three components of the system will be ready for clinical use in two years’ time.

Contact:

Martin Lamß

Fraunhofer Institute for Machine Tools and Forming Technology IWU
Reichenhainer Str. 88
09126 Chemnitz

Phone +49 371 5397-1454

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A significantly lower prevalence of osteolysis and revision was also found in the highly cross-linked polyethylene liner group.

Patients with degenerative hip disease who received a highly cross-linked polyethylene liner during total hip replacement experienced significantly reduced wear and had greater implant survival at 10 postoperative years than patients who received ultra-high molecular weight polyethylene liners, according to study results.

Peter A. Devane, MBChB, MSc, FRACS, and his colleagues randomly assigned 122 patients undergoing total hip arthroplasty for degenerative hip disease to receive either a Enduron conventional ultra-high molecular weight polyethylene liner (UHMWPE) (DePuy) or a Marathon highly cross-linked polyethylene liner (XLPE) (DePuy). Researchers collected Oxford Hip Scores and SF-12 Healthy Survey scores in 91 patients who were available for follow-up at 10-years postoperatively. They also used validated software to analyze radiographs for osteolysis and for 2-dimensional, 3-D and volumetric wear.

Results showed a mean wear rate of 0.03 mm per year and of 0.27 mm per year for patients in the highly XLPE liner group and UHMWPE group, respectively. There was a significantly lower prevalence of osteolysis in the highly XLPE liner group at 10-years postoperatively. Despite that finding, Devane said in an interview with Orthopedics Today it was surprising osteolysis could still occur when highly cross-linked polyethylene was used.

“We believe the osteolysis seen with the highly [cross-linked polyethylene liner] XLPE in our study came from premature loosening of a less than optimal cemented femoral stem,” Devane told Orthopedics Today.

Similarly, patients in the highly XLPE group had a significantly lower revision rate, according to results, with 10 of 12 revisions being in the UHMWPE liner group. However, researchers found no significant differences between the groups based on the Oxford Hip Scores or SF-12 mental or physical well-being scores.

By Orthopedics Today (Healio)

Image Credit: DePuy Synthes

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FundamentalVR is launching a virtual reality surgery training platform using haptics and physical feedback to create a tactile, flight simulator-like experience for surgeons.

The software platform, Fundamental Surgery, aims to recreate the real-life sensations of using several different medical tools with tissue, muscle and bone in a variety of procedures. Using off-the-shelf hardware, the London-based company aims to make its hands-on system available for less than the cost of a single surgical training cadaver.

Its first U.S. programs will focus on orthopedic training, including posterior hip replacements, total knee arthroplasties and spinal pedicle screw placements. FundamentalVR plans to offer additional orthopedic procedures before the end of the year, with other disciplines such as cardiovascular and general surgery going live in 2019.

“Our mission is to democratize surgical training by placing safe, affordable and authentic simulations within arm’s reach of every surgeon in the world,” Richard Vincent, founder and CEO of FundamentalVR, said in a statement.

Typically, surgical training consists of classroom-based theory, theater-style viewing of cadaver-based teaching, observation in the operating room, limited hands-on cadaver practice, and closely monitored involvement with live patients, as well as, increasingly, online videos.

“With the help of some of the top minds in medicine, as well some of the most advanced VR and haptic programmers, we have created a solution that can be deployed anywhere—with limited investment—to allow surgeons to learn and hone their skills over and over again in a safe and controlled environment,” Vincent said.

By Conor Hale | FierceMedTech

Image Credit: FundamentalVR

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The most advanced, patient conforming hip replacement system designed to enhance operational efficiency for the surgeon and improve patient outcomes

BILLERICA, Mass., Aug. 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers patient conforming joint replacement implants, today announced completion of the first two Conformis Hip System implants. The Conformis Hip System is the first ever 3D designed primary total hip replacement system. The first surgeries were performed by Gregory Martin, M.D., Joint Fellowship Trained Orthopedic Surgeon and founder of Personalized Orthopedics of the Palm Beaches, and took place at a leading HCA Facility, JFK Medical Center in Atlantis, Florida on July 31, 2018.

“Partnering with our expert surgeon design team and leveraging our extensive experience in automated 3D printing and additive manufacturing enabled us to bring a revolutionary new hip replacement system to market. Our 3D implant design process provides surgeons with interactive input and improves operational efficiencies compared to 2D templating. The design process produces specific individualized pre-navigated cutting guides and implants. A groundbreaking acetabular reaming system has also been developed,” said Mark Augusti, chief executive officer and president of Conformis. “With this launch, we expect to lead the way in innovative solutions for the $7B hip replacement market by providing surgeons with game-changing operative solutions to better serve them and their patients both in hospitals and ambulatory surgical settings.”

Similar to the design process for the Conformis Knee technologies, the Conformis Hip System uses proprietary advanced imaging and design software, to design, manufacture and deliver the suite of FDA-cleared patient conforming Knee and Hip replacement implants. After each patient’s CT scan is converted into a 3-dimensional computer model, the unique measurements of each patient’s anatomy are transformed into a comprehensive, individualized, pre-operative surgical plan that is delivered to the surgeon well in advance of the operation. Surgeons are able to collaborate with Conformis during the planning process in order to design the optimal Hip System for each patient based on surgeon preferences.

“The Conformis Hip System is designed to address many of the short comings of primary hip replacement today. For the first time, orthopedic surgeons have a fully-guided system designed to address the wide variations in anatomy presented across our cases,” said Dr. Martin M.D*, a member of the surgeon design team. “The Conformis system builds upon traditional methods for hip replacement surgery with proven materials and components which, today, are offered in only limited standard configurations. Due to the accuracy of the personalized pre-operative surgical plan, the 3D printed patient conforming cutting guides and hip implant components, my hope is that with the new Conformis Hip system, surgeons will be able to improve both patient outcomes and operational efficiencies.”

Each component of the Conformis Hip System is pre-navigated to fit the patient, with certain components designed specifically for that patient. The Conformis Hip System is delivered directly to the hospital or surgery center in a single patient-labeled kit, eliminating the need for excess inventory. Patient conforming, single-use, 3D printed cutting guides are also included, limiting the need for the vast amount of reusable instruments required for a standard off-the-shelf total hip replacement.

The first two Conformis Hip System surgeries were conducted as part of a limited launch. Timing for a complete commercial launch is expected to be announced in 2019.

The global hip joint reconstruction market is projected at over $7B, and about 400,000 total hip replacements are performed in the United States each year.

*Gregory Martin, MD is a consultant to Conformis, Inc.

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems and a hip system that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses over 400 issued patents and pending patent applications that cover patient-specific implants and instrumentation for all major joints. In clinical studies, Conformis iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You should not place undue reliance on our forward-looking statements. Actual results could differ materially from the expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Media Contact:

Kelly Wakelee
kwakelee@berrypr.com
(212)-253-8241

Investor Contact:

Oksana Bradley
ir@conformis.com
(781) 374-5598

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An award-winning software by ORamaVR connects five different cities and four leading medical schools worldwide, transforming virtual surgical training for ever

Stanford, CA: Surgical training is being transformed, as ORamaVR has demonstrated the first-ever international VR co-operative surgical training, linking together the Stanford Medical School, the USC Keck School of Medicine, the NYU Langone Medical School and the Aristotle University Medical School. World-renown surgeons and residents from these medical schools collaborated fully during a simulated Total Hip arthroplasty operation, with five remote participants located in Stanford, Los Angeles, New York in USA and Thessaloniki, Heraklion in Greece:

First-ever shared collaborative orthopaedic surgery in VR - YouTube

“Our residents cannot easily memorize the complete and complex sequence of events during an arthroplasty operation unless they perform it first numerous times with their own hands. Now via the ORamaVR co-operative software this is possible for anyone, anytime, anywhere and even remotely.” – Prof. Eleftherios Tsiridis, ORamaVR CMO

“For the first time in the history of online, collaborative virtual environments, we are now able to empower surgeons and their residents to be fully present in the virtual operating room, communicate and actively operate together on a virtual patient.”
Prof. George Papagiannakis, ORamaVR CEO/CTO

Among the first clients to adopt the ORamaVR co-operative products are the USC Keck School of Medicine, Los Angeles, the NYU Langone Health in New York, the Foundation of Research and Technology – Hellas and University of Athens in Greece as well the Biomedical and Multimedia Information Technology group at the University of Sydney, Australia. ORamaVR has been awarded the prestigious FARE award, together with NYU, from the American Association of Hip and Knee Surgeons (May 2018) as well as the second prize in the 8th Innovation & Technology Competition organized by the National Bank of Greece (May 2018).

About ORamaVR: ORamaVR (http://www.oramavr.com) is a VC-backed startup (PJ Tech Catalyst Fund) that focuses on transforming the medical education (knowledge) and training (skills) of surgeons through innovative virtual reality simulation and skill transfer from the virtual to the real operating room, thereby reducing errors and improving patient outcomes. The Co-founders of ORamaVR are Prof. George Papagiannakis, Prof. Eleftherios Tsiridis, Prof. Panos Trahanias as well as the Institute of Computer Science of the Foundation for Research and Technology – Hellas.

Media Contact:

Prof. Eleftherios Tsiridis, PhD, MD
ORamaVR Chief Medical Officer, Vice President
+30 2310390599
eleftherios.tsiridis@oramavr.com

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The American Association of Hip and Knee Surgeons presents NYU and ORamaVR with the prestigious FARE award

New York, USA: The New York University and ORamaVR received the prestigious AAHKS Fare Grant Award on May 8th during the AAHKS Spring meeting, for their joined groundbreaking clinical study. The purpose of this study is to assess the skill transfer, educational value, and validity of a virtual reality (VR) surgical simulator for total hip arthroplasty.

“We anticipate that life-like immersive VR will facilitate and enhance the transfer of surgical skills to real-world surgical procedures, allowing for improved proficiency in the operating room” – Prof. Bill Macaulay, NYU

“This ground-breaking, large-scale clinical study aims to establish for the first time in the bibliography clear % gains via VR medical simulation in a) training time reduction b) success rates and c) training cost reduction with commodity VR hardware” – Prof. Eleftherios Tsiridis, ORamaVR CMO

More details of the award are available online on page 14 here: http://www.aahks.org/wp-content/uploads/2018/05/aahks-update-may-2018-web.pdf

About ORamaVR:

ORamaVR is medical VR technology startup that aims to transform medical education and training. Co-founders of ORamaVR are Prof. George Papagiannakis, Prof. Eleftherios Tsiridis, Prof. Panos Trahanias as well as the Institute of Computer Science of the Foundation for Research and Technology – Hellas. ORamaVR was founded in August 2016, receiving 500K EUR capital investment from the PJTech Catalyst VC fund in Greece. The Medical School of the Aristotle University of Thessaloniki as well as the Papageorgiou University Hospital have been fully endorsing the company and mission.

Media Contact:

Prof. Eleftherios Tsiridis, PhD, MD
ORamaVR Chief Medical Officer, Vice President
+30 2310390599
eleftherios.tsiridis@oramavr.com
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