Month: May 2022

Register: 2022 Masters Course in Shoulder Arthroplasty

There’s still time to invite your surgeon targets to next month’s shoulder Masters Course in New York City. See below to for details on the event and how to register.

2022 Masters Course in Shoulder Arthroplasty – June 9-10, 2022

With a 90% close rate, you can’t miss this opportunity to welcome and convert your targets to Exactech and the Equinoxe System. Watch the above video to see what your colleagues think about this course.
View Detailed Agenda
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Shoulder Surgeons Perform First U.S. Surgeries Using Exactech’s Next Generation Cage Glenoid

The Equinoxe® Laser Cage Glenoid, an innovative, next-generation shoulder implant designed to improve glenoid fixation in anatomic total shoulder arthroplasty

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Shoulder Surgeons Perform First US Surgeries Using Exactech’s Next Generation Cage Glenoid

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GAINESVILLE, Fla. (May 24, 2022) – Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced successful first surgeries using the Equinoxe® Laser Cage Glenoid, an innovative, next-generation shoulder implant designed to improve glenoid fixation in anatomic total shoulder arthroplasty.

This new glenoid implant, available in standard and augmented options, features a central bone cage and three peripheral cage pegs. Each cage peg is titanium, porous and 3D-printed. First surgeries were performed by Bradley Schoch, MD, of the Mayo Clinic (Jacksonville, Fla.), and Sean Grey, MD, of the Orthopaedic & Spine Center of the Rockies (Fort Collins, Colo.) – two of the product’s design surgeons.

Exactech’s manufacturing process for the Laser Cage Glenoid is unique. Its 3D-printed cage pegs are directly molded to the backside of the ultra-high molecular weight polyethylene (UHMWPE) articular surface, so there is no mechanical locking mechanism. Preclinical testing demonstrated the device successfully withstood cyclic loading at 3,750N (~850lbs) when implanted 5mm proud (simulating a glenoid that is not fully seated) – an extreme loading magnitude and configuration relative to industry standards.1*

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...Mechanical bench testing has demonstrated the remarkable strength of the 3D-printed porous cage pegs, which offer the potential for bone through-growth and better fixation relative to all-polyethylene glenoids...
Sean Grey, MDOrthopaedic & Spine Center of the Rockies
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“I am impressed by the mechanical strength1* of this unique hybrid design. Mechanical bench testing has demonstrated the remarkable strength of the 3D-printed porous cage pegs, which offer the potential for bone through-growth and better fixation relative to all-polyethylene glenoids,” said Dr. Grey.

The Laser Cage Glenoid builds upon the foundation of the original cage glenoid design, which has been clinically available since 2011. Clinical studies on Exactech’s original cage glenoid have shown that its titanium pegs are associated with a four-fold reduction in the occurrence of radiolucent glenoid lines, as compared to all-polyethylene cemented peg glenoid designs.2 Additionally, the cage glenoid’s wedge augmented design requires less glenoid reaming and preserves more bone than step-augmented glenoid designs.3*

“The Laser Cage Glenoid is provided in multiple sizes of posterior augments, which helps me preserve bone. The wedge-augmented implant design minimizes reaming when correcting glenoid deformity,3 and the porous cage peg design provides excellent initial fixation” said Dr. Grey.1-3*

Another design surgeon, Thomas Wright, MD, of the University of Florida (Gainesville, Fla.), said, “Exactech is committed to innovation, and this new glenoid implant highlights their intense focus on designing new devices that address unmet clinical needs, like aseptic glenoid loosening, offering the potential for better outcomes for my patients. This new implant is the next generation of a well-proven design with more than 11 years of clinical use, and I am proud to help Exactech bring this important new device to the U.S. market.”

The Laser Cage Glenoid is in pilot launch in the United States. In addition to Drs. Grey, Schoch, and Wright, the surgeon design team includes Stephen Brockmeier, MD, of the University of Virginia Health System, Pierre-Henri Flurin, MD, of the Surgical Clinic of Bordeaux, and Joseph Zuckerman, MD, of the NYU Langone Orthopedic Hospital.

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About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit staging.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.

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  1. Testing on file.* 
  2. Friedman, R. et al. Clinical and Radiographic Comparison of a Hybrid Cage Glenoid to a Cemented Polyethylene Glenoid in Anatomic Total Shoulder Arthroplasty. J Shoulder Elbow Surg. 2019 Dec;28(12):2308-2316. 
  3. Roche, C. et al. Biomechanical Impact of Posterior Glenoid Wear on Anatomic Total Shoulder Arthroplasty. Bulletin for the Hospital for Joint Diseases. 71(2):S5-11. 2013.* 

*In vitro (bench) test results may not necessarily be indicative of clinical performance. 

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Media contact

Samantha DiVirgilio
Marketing Communications Manager
Samantha.divirgilio@exac.com

3D CT Preoperative Planning in Shoulder Arthroplasty: Differences in Industry Technician and Surgeon Planning

Given the increased use and availablilty of preoperative planning in shoulder arthroplasty, improved knowledge of how surgeons plan, the ability to execute the plan, and factors associated with planning is needed.

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[us_iconbox icon=”fas|fas fa-user-md-chat” style=”circle” size=”20px” iconpos=”left” title=”Contributor” title_size=”20px” title_tag=”h3″ alignment=”left” css=”%7B%22default%22%3A%7B%22font-family%22%3A%22Roboto%22%7D%7D”]Joseph J. King, MD
UF Health Orthopaedics and Sports Medicine Institute[/us_iconbox][us_separator]

Hartzler and colleagues1 evaluated the rates of surgeon agreement compared to an industry technician team regarding the 3-dimensional preoperative plan for placement of shoulder arthroplasty components in 6,483 cases (aTSA and rTSA).  The industry technicians used some general principles to follow when creating the plan and were trained in this process.  Aditionally, all plans underwent a peer-reviewed process prior to be accepted by the team.  The patient-specific instrumentation used in this study utilized a reusable device with 5 points of contact on the glenoid surface.  This device targets the central glenoid pin used in this system.  This study focused on the central glenoid pin placement regarding version and inclination.

The authors demonstrated that there was a moderate rate of surgeon acceptance of the plan (66% version, 72% inclination, and 55% for both).  Notably, 45% of plans showed at least version or inclination were not accepted by the surgeon with 18% of cases having neither plan accepted by the surgeon.  While in a “majority” of cases the plan was accepted, this still shows a relatively high lack of acceptance of the plan that was generated using general guidelines.

Interestingly, the authors noted that on univariate analysis, as the surgeon’s case count increased, their acceptance of technician planned version decreased.  This suggests that with experience using the preoperative planning system or just surgeon experience caused the surgeons to not accept the standardized plan.  This highlights the fact that experienced surgeons likely use other factors besides the general guidelines when considering preoperative glenoid planning.  This study adds to the literature regarding surgeon variability in preoperative planning in differing clinical scenarios. 2,3

The authors demonstrated that there was a moderate rate of surgeon acceptance of the plan (66% version, 72% inclination, and 55% for both). 6

Increasing native glenoid version was another factor on univariate analysis that caused decreased surgeon agreement with the technician planned implant version.  Again, this shows that in difficult cases (with significant glenoid wear), other factors besides the general guidelines are used by surgeons for planning implant version.

Limitations of this study include the fact that only glenoid version and inclination were assessed.  Change in the inferior/ superior or anterior/ posterior position of the central pin as well as the planned depth of reaming was not assessed.  In addition, while understanding planning is important, in vivo execution of the plan and/or intraoperative acceptance of the patient specific instrumentation guide was not assessed.  Studies have shown that even with preoperative planning, the in vivo execution of the plan still can be off a significant amount of the time.4,5

Of note, some of the same authors found that different preoperative planning software leads to different measurements in native version and inclination whereas the surgeons in that study had relatively high inter-observer reliability, demonstrating that measurements of even native version and inclination by preoperative planning softwares differ.6

The authors do mention the risks of anchoring bias and authority bias when accepting or changing the plan in these scenarios.  They make a good point that maybe it is better to let the surgeon plan from the beginning without industry input to avoid these biases, although this was not evaluated in this study.  The authors caution surgeons to avoid blind acceptance of the industry technician preoperative plan in shoulder arthroplasty given the findings of this study.  I agree with this assessment as there are many factors to consider when planning including remaining glenoid bone stock, location of central pin vault penetration, backside support of the implant, ease of implant placement, and availablilty of glenoid augments, amongst other factors all play a role in surgeon preoperative planning.

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References

  1. Hartzler RU, Denard PJ, Griffin JW, Werner BC, and Romeo AA. “Surgeon acceptance of an initial 3D glenoid preoperative plan: rates and risk factors.”  J Should Elb Surg.   30: 787-94.
  2. Greene A, Cheung E, Polakovic S, Hamilton M, Jones R, Youderian A, et al. Inter-surgeon variability in using 3D planning software for reverse total shoulder arthroplasty: an analysis of 360 cases. Orthop Proc. 101-B:64.
  3. Parsons M, Greene A, Polakovic S, Byram I, Cheung E, Jones R, Papandrea R, Youderian R, Wright T, Flurin PH, Zuckerman JD. Assessment of surgeon variability in preoperative planning of reverse total shoulder arthroplasty: a quantitative comparison of 49 cases planned by 9 surgeons. J Should Elbow Surg.  29(10): 2080-88.
  4. Hao KA, Sutton CD, Wright TW, Schoch BS, Wright JO, Struk AM, Haupt ET Leonor T, King JJ. Influence of glenoid wear pattern on glenoid component placement accuracy in shoulder arthroplasty.  JSES Int.  6(2): 200-8.
  5. Schoch BS, Haupt E, Leonor T, Farmer KW, Wright TW, King JJ. Computer navigation leads to more accurate glenoid targeting during total shoulder arthroplasty compared with 3-dimensional preoperative planning alone. J Should Elbow Surg.  29(11): 2257-63.
  6. Erickson BJ, Chalmers P, Denard P, Lederman E, Horneff G, Werner BC, Provencher M, Romeo AA. Does commercially available shoulder arthroplasty preoperative planning software agree with surgeon measurements of version, inclination, and subluxation?  J Should Elbow Surg.  30(2): 413-20.
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Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System

Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System

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GAINESVILLE, FLA. (May 17, 2022) – Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System.

Exactech, a minority shareholder of JointMedica Limited, is collaborating with the United Kingdom-based orthopaedic device designer and manufacturer to deliver the next generation of hip resurfacing to the global market, and holds exclusive global distribution rights to the product.

“This designation by the FDA is a validation of our core belief at JointMedica—that our hip resurfacing device addresses an acute unmet need of relatively younger, active hip arthritis patients,” said Terence Smith, Managing Director of JointMedica.

According to Exactech Chief Strategy Officer, Sharat Kusuma, MD, “We are thrilled that PolyMotion and JointMedica have been recognized as one of only 71 orthopaedic devices that have received breakthrough designation since the inception of this program.  We aspire to accelerate Polymotion hip resurfacing development and help more patients get back to all the activities they love.”

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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...The introduction of metal-on-vitamin E crosslinked polyethylene hip resurfacing would be most welcomed by me as a practicing surgeon and well-received by my patient community...
Craig J. Della Valle, MDMidwest Orthopaedics at Rush
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“Hip Resurfacing remains an excellent choice for young, active patients, who will inevitably place a higher demand on their hip reconstruction. The introduction of metal-on-vitamin E crosslinked polyethylene hip resurfacing would be most welcomed by me as a practicing surgeon and well-received by my patient community,” said Craig J. Della Valle, MD, of Midwest Orthopaedics at Rush in Chicago, Illinois.

Dr. Della Valle is joined by colleague Scott Marwin, MD, of NYU Langone Orthopedic Hospital, in an advisory role in submitting for the breakthrough designation.

“Through this deep collaboration Exactech and JointMedica are well positioned to bring the Polymotion Hip Resurfacing System to the global market. Partnering with surgeons at the early stages of development has always served a fundamental role in our success,” said Jeff Binder, CEO and Chairman of the Board of Exactech. “Polymotion will complement Exactech’s Alteon® hip arthroplasty portfolio, comprised of substantial advancements in design and materials to time-tested solutions.”

With more than three decades of experience using hard-on-hard articulations in hip resurfacing, Derek McMinn MD, FRCS, and Ronan Treacy, MD, FRCS, designed the Polymotion Hip Resurfacing System to leverage the clinically successful design principles of their previous hip resurfacing devices, now with advanced polyethylene and titanium manufacturing technology. The Polymotion hip offers the biomechanical benefits of hip resurfacing but eliminates metal-on-metal articulating surfaces.

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About JointMedica

JointMedica is an orthopaedic design and development “Think Tank,” intending to advance and disseminate new concepts which result in the creation of innovative orthopaedic implants. Our objective is to form close relationships with key orthopaedic surgeons, empowering the creation of products that are highly innovative while at the same time meeting the heightened expectations of patients along with the stringent quality and safety standards that apply to modern orthopaedic implants.

Visit www.jointmedica.com

Contact cs@jointmedica.com

About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit staging.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.

Polymotion® & POLYMOTION®. Registered trademarks of JointMedica

Alteon®.  Registered trademark of Exactech

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Media contact

Morgan Lee
Exactech Marketing Communications
Morgan.lee@exac.com