Author: Jenna Spencer

Exactech Connects Surgeons and Patients on Another Level with High NPS® and New Message Streams

New shoulder sports medicine, arthroscopy and arthroplasty exacCoach™ message streams to connect more surgeons and patients throughout the journey of care.

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exacCoach Shoulder Message Stream

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GAINESVILLE, Fla. (Aug. 8, 2022) – Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, unveiled new shoulder sports medicine, arthroscopy and arthroplasty exacCoach™ message streams to connect more surgeons and patients throughout the journey of care. These expanded offerings build on the company’s powerful exacCoach patient text messaging platform that has received an overwhelmingly positive response with a Net Promoter® Score (NPS) of 98 points.

One of the first adopters of the new shoulder messaging stream is the Orthopedic Institute in South Dakota. “We have received amazing feedback from our patients about the exacCoach messaging,” said Jason Hurd, MD, shoulder and elbow specialist. “It has been a great, easy-to-use technology that allows us to stay connected with our patients and keep them informed.”

Louise Van Peursem, patient navigator at the Orthopedic Institute, added, “The exacCoach technology automates text messages to help our patients with their upcoming surgeries. So far, our patients have had really great things to say.”

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...“One patient commented that it was like I knew exactly what was happening to her right in the moment, if it were not for the exacCoach messages and receiving them so well-timed, she would have been on the phone a lot with our staff.”...
Yale Fillingham, MDRothman Orthopaedics in Penn.
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Powered by Active Intelligence®, the exacCoach technology allows surgeons to virtually coach their patients through automated text messages from surgical preparation through rehabilitation, so they can be with them every step of the way. The system is designed to increase patient satisfaction through detailed and encouraging information that is personalized to each surgeon and practice.

“We’re now seeing knee patients who were enrolled in the messaging stream back in the clinic for their four-week postop appointments,” said Yale Fillingham, MD, a hip and knee surgeon at Rothman Orthopaedics in Penn. “One patient commented that it was like I knew exactly what was happening to her right in the moment.” He went on to say, “if it were not for the exacCoach messages and receiving them so well-timed, she would have been on the phone a lot with our staff.”

The exacCoach technology helps keep patients properly informed, while increasing office efficiencies, reducing time spent with patient management and allowing for new patient visits, enrollments and additional surgeries.

“Exactech is committed to building clinically efficacious, low friction technology offerings that create value for hospitals and surgeons,” said Sharat Kusuma, MD, Exactech Chief Strategy Officer and Chief Medical Officer. “Our GPS technology is evidence of this, with its capital-cost free model. We are excited that the exacCoach messaging service is another Exactech offering that shares these characteristics.”

Exactech is well into the release of its exacCoach messaging platform with plans to onboard additional practices, as well as introduce automatic patient enrollment options through the second half of 2022. For more information, visit www.exacCoach.com.

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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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*Net Promoter®, NPS®, NPS Prism®, and the NPS-related emoticons are registered trademarks of Bain & Company, Inc., Satmetrix Systems, Inc., and Fred Reichheld. Net Promoter Score℠ and Net Promoter System℠ are service marks of Bain & Company, Inc., Satmetrix Systems, Inc., and Fred Reichheld.”

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Media contact

Courtney Adkins
Senior Marketing Communications Manager
courtney.adkins@exac.com

Stay Ahead of the Curve

We’ve got 10+ fresh new videos for Newton Knee & GPS Knee to help you stay ahead of the competition.

Gain insights through a market dynamics presentation and competitive overview. Sharpen your knowledge through troubleshooting tutorials, back table videos and more.

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New Study Doubles Down on Debridement vs. Balloon

Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multi-centre randomized controlled trial

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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”]Gregory Gilot, MD
Cleveland Clinic Florida[/us_iconbox][us_separator]

Andrew Metcalfe, Helen Parsons, Nicholas Parsons, Jaclyn Brown, Josephine Fox, Elke Gemperlé Mannion, Aminul Haque, Charles Hutchinson, Rebecca Kearney, Iftekhar Khan, Tom Lawrence, James Mason, Nigel Stallard, Martin Underwood*, Stephen Drew*, on behalf of the START:REACTS team

To review is to opine 

Rotator cuff tears are a common cause for shoulder pain and disability.  While the majority of rotator cuff tears are amenable to surgical repair, a third of tears cannot be repaired to its original site of attachment. Massive irreparable rotator cuff tears remain a challenge for the shoulder surgeon in any age range.  Patients with irreparable tears have worse outcomes from traditional rotator cuff surgery and have fewer treatment options.  As a result, novel surgical procedures have been introduced as options for these complex situations. The InSpace subacromial balloon spacer device (Stryker, USA) is a saline-filled biodegradable balloon inserted into the subacromial space. The device maintains this space with the goal of improving the mechanics of the shoulder and aid rehabilitation.

Summary

The purpose of the study was to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. The authors recognize the potential harm patients are exposed to when a new surgical procedure is introduced. In addition, the authors recognize the need for careful evaluation of new surgical procedures before widespread use.

The purpose of the study was to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.

Materials and Methods

A double-blind multi-centre, superiority randomized controlled trial across 24 hospitals in the UK was performed using a group sequential adaptive design with two preplanned interim analyses. Adults with symptomatic irreparable rotator cuff tears and for whom conservative management had been unsuccessful were included. The control group (debridement only) underwent arthroscopic debridement of the subacromial space and biceps tenotomy. The intervention group (debridement and device) underwent the same procedure with the insertion of the InSpace balloon using the manufacturer’s recommended technique. All participants were offered the same rehabilitation. All primary (Oxford Shoulder Score) and secondary outcomes (Constant Score, flexion and abduction, WORC Index, EuroQol, EQ-5D-5L, change in symptoms, Participant Global Impression of Chane, resource use, and adverse events) were assessed at 3, 6, and 12 months.

Results

One hundred seventeen participants were randomly allocated to a treatment group, 61 to the debridement only group and 56 to the debridement with device group. The average age of the debridement only group was 67·3 (+/-9·0) 66·4 (+/-7·6) for the debridement with device group. Fifty-seven percent of all participants were male, the average duration of symptoms was4·9 (6·7) years, and 21% had previous surgery. The mean tear size was similar between groups (debridement only 4.3cm versus debridement with device 4.2cm).

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Results at 12 months
Outcome Mean Difference or

Adjusted Odds Ratio

Adjusted mean difference* (95% CI)

*Negative values favour the debridement-only group

**OR with 95% CI with Fishers exact test.

Comment
Oxford Shoulder Score –4·2 (–7·8 to –0·6) Not significant,

favoring debridement only

WORC Index –8·4 (–16·8 to –0·1) Not significant,

favoring debridement only

EQ-5D-5L –0·056 (–0·150 to 0·035) Not significant,

favoring debridement only

 Participant Global Impression of Change, since the operation 0·5 (0·3 to 1·1)|| Not significant,

 

Analgesia Use  0·8 (0·4 to 1·8)**

 

Safety Events
 Debridement

only (n=61)

 Debridement

with device

(n=56)

Overall 9 (15%) 11 (20%)
Any Serious Adverse Events 2 (3%) 4 (7%)
Unrelated to Surgery 1 (pain after fall) 2 (pain after fall, proximal humerus fracture after fall)
Related to Surgery 1 (pain) 2 (pain, 1 converted to RSP)

Discussion

A blinded randomized controlled trial design with predefined stopping boundaries allowed the study to be stopped at more than half the maximum potential sample size of 221 participants allowing the authors to report their findings early. During the time of the study the COVID-19 restrictions limited face-to-face assessments therefore there was a high amount of missing data. In the primary analysis the authors found that arthroscopic debridement only was superior to arthroscopic debridement with the InSpace device based on the Oxford Shoulder Score at 12 months. In addition, secondary outcomes were similar to the primary outcome.

Conclusions

Through this adaptive design methodology with interim analyses the authors concluded that the InSpace device is unlikely to be of benefit and may be harmful to this patient population. The authors recommended against the use of the InSpace subacromial balloon spacer device for the treatment of irreparable rotator cuff tears.

Reviewer Comments

Lancet is one of the most prestigious medical journals with an impact factor of ~80, and the authors’ conclusions are strongly worded and in sharp contrast to that of the recent JBJS study on the balloon. Additional clinical research is required on this device, and it will be interesting to see in the coming years which of these studies on the balloon more accurately describes the clinical performance of the InSpace for treatment of irreparable rotator cuff tears.

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Metcalfe A, Parsons H, Parsons N, Brown J, Fox J, Gemperlé Mannion E, Haque A, Hutchinson C, Kearney R, Khan I, Lawrence T, Mason J, Stallard N, Underwood M, Drew S; START:REACTS team. Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial. Lancet. 2022 May 21;399(10339):1954-1963. doi: 10.1016/S0140-6736(22)00652-3. Epub 2022 Apr 21. PMID: 35461618.

Verma N, Srikumaran U, Roden CM, Rogusky EJ, Lapner P, Neill H, Abboud JA; SPACE GROUP. InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears: A Multicenter, Single-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2022 Apr 22. doi: 10.2106/JBJS.21.00667. Epub ahead of print. PMID: 35777921.

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Exactech Launches Significant Update to Equinoxe® Shoulder Preoperative Planning App

Smart technology features humeral planning and other major enhancements that offer surgeons a complete view of patient solutions

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Equinoxe Shoulder Preoperative Planning App

Equinoxe® Planning App v2.1: A redesigned interface gives surgeons increased flexibility to plan placement and select implants and sizes for the scapula and humerus based on a patient’s specific anatomy. A combined joint screen allows surgeons to assess shoulder range of motion and impingement.

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GAINESVILLE, Fla. (July 18, 2022) – Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, today announces the U.S. release of the Equinoxe® Shoulder Planning App v2.1, giving surgeons increased flexibility to plan shoulder component placement and select implants and sizes for the scapula and humerus based on a patient’s specific anatomy.

The shoulder preoperative planning software can be used with the ExactechGPS® navigation system in the operating room, connecting the preoperative plan with implant placement. Recent studies demonstrate GPS provides verified placement accuracy within 2mm and 2 degrees of the preoperative plan1,2, better fixation1-4 and improved clinical outcomes compared to non-navigated groups, including improved range of motion and reduced postoperative complications, revision rates and adverse events.5

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...The ability to assess range of motion and impingement as a function of implant configuration complements my ability to determine the optimal plan that can positively impact each patient’s outcome...
Moby Parsons, MDThe Knee, Hip and Shoulder Center
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The latest Equinoxe Planning App version features:

  • Humeral planning, with a range of Equinoxe humeral stem components and sizes, including the Stemless Shoulder and Preserve short stem
  • Views for stem anterior/posterior, medial/lateral and inclination positions
  • Humeral head offset and position adjustment in anatomic procedures
  • Humeral tray and liner planning for reverse procedures
  • Patient neutral abduction position refinement
  • Views of the total joint and use of combined motions to assess shoulder range of motion and impingement at specific locations
  • A redesigned, enhanced user interface
  • Easy access to Predict+™, the first machine learning-based clinical decision support tool for shoulder surgery

“The enhancements to the Equinoxe Planning App allow me to truly personalize each reconstruction in a patient-specific fashion,” said Moby Parsons, MD, a joint replacement surgeon at The Knee, Hip and Shoulder Center (Portsmouth, NH) and Equinoxe/GPS design team member. “The addition of humeral-sided planning provides a full suite of planning solutions that incorporates the comprehensive portfolio of implants that Equinoxe offers. The ability to assess range of motion and impingement as a function of implant configuration complements my ability to determine the optimal plan that can positively impact each patient’s outcome. When combined with the actionable insights provided by Predict+, which has also been added to the Planning App, I can now manage solutions for my patients that are driven by Active Intelligence®.”

“Since the launch of the original Equinoxe Planning App, surgeons have planned more than 50,000 shoulder cases and executed their plans in 30,000+ cases using GPS,” said Exactech Senior Vice President of Extremities Chris Roche. “The Planning App, combined with GPS, makes the system the first and only shoulder navigation technology that connects the preoperative plan with real-time intraoperative instrument guidance – and verifies implant placement. The new features added to the Planning App highlight Exactech’s drive to create new solutions that enhance our surgeons’ surgical experiences.”

International market clearance of the Planning App v2.1 is targeted for the fourth quarter. Download the Equinoxe Planning App at www.AISurgeon.com and explore all of Exactech’s Active Intelligence technologies

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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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References:

  1. Greene A. et al. Navigated vs. non-navigated results of a CT based computer assisted shoulder arthroplasty system in 30 cadavers. Presented at ISTA 2018.*
  2. Nashikkar P. et al. Role of intraoperative navigation in the fixation of the glenoid component in reverse total shoulder arthroplasty: a clinical case-control study. J Shoulder Elbow Surg. 2019 Sept.;28(9):1685-1691.
  3. Nashikkar P. et al. Computer navigation re-creates planned glenoid placement and reduces correction variability in total shoulder arthroplasty: an in vivo case-control study. J Shoulder Elbow Surg. 2019 Dec;28(12):e398-e409.
  4. Roche C. et al. Impact of screw length and screw quantity on rTSA glenoid fixation for two different sizes of glenoid baseplates. JSES Open Access (JSESOA-D-19-00048R1).*
  5. Greene A. et al. Two-year clinical outcomes of total shoulder arthroplasty performed with a computer navigated surgery system. Presented at CAOS 2022.

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

The Equinoxe Planning App is used exclusively with the Equinoxe Platform Shoulder System and its comprehensive glenoid and humeral solutions. ExactechGPS and the Equinoxe Planning App are manufactured by Blue Ortho, a subsidiary of Exactech, and distributed by Exactech.

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Media contact

Nancy Walsh
Director, Marketing Communications
nancy.walsh@exac.com

Exactech Announces Successful First Surgeries with Latest Instrumentation for Its Newton™ Balanced Knee Technology

With a rich array of pre-clinical data, the Newton Knee is at the forefront of Exactech’s focus to improve clinical outcomes by utilizing soft tissue balancing technology in total knee replacement patients.

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Newton Knee – Dynamic platform of cutting-edge technology and forward-thinking implants designed to provide optimal balance in a reproducible way.

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GAINESVILLE, Fla. (July 14, 2022) – Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced today first surgeries leveraging the power of the Newton™ Knee, featuring new, user-friendly instrumentation and a modernized graphical user interface. With a rich array of pre-clinical data, the Newton Knee is at the forefront of Exactech’s focus to improve clinical outcomes by utilizing soft tissue balancing technology in total knee replacement patients.

Orthopaedic surgeons James Huddleston, MD, Stanford University, Raul Marquez, MD, Cornerstone Orthopedic Institute, and Jeffrey R. Ginther, MD, Rush Memorial Hospital, were the first to perform the surgeries.

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...Optimal soft tissue balance, combined with personalized implant placement, has the potential to improve on the historical outcomes of knee replacement...
James Huddleston, MDStanford University
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“Optimal soft tissue balance, combined with personalized implant placement, has the potential to improve on the historical outcomes of knee replacement,” Dr. Huddleston said. “Exactech is yet again leading the way with the Newton Knee, merging well-thought-out design and leading-edge technology to deliver real-time operative insights for balanced knee replacement results.”

The Newton Knee platform features updated instrumentation that seamlessly integrates with the company’s flagship and award-winning Truliant® system. The instruments offer surgeons additional ergonomically designed options that allow for intra-operative flexibility. According to Dr. Ginther, “Exactech has made continual ‘smart’ changes to evolve the instrument portfolio into an even better and more user-friendly system. The integration of the new instrumentation provides critical intra-operative data regarding soft tissue balance, which I find invaluable.”

The Newton Knee works in concert with the pioneering guidance system, ExactechGPS®, which provides real-time feedback through its powerful active technology, at zero capital cost. Dr. Marquez commented, “The dynamic nature of the Newton Knee is designed to reliably tense patients’ ligaments throughout the full arc of motion. This allows me to both personalize implant placement and balance the soft tissues as appropriate for the patient’s anatomy, rather than only modifying soft tissue to meet the needs of the implant. By personalizing both hard and soft tissue preparation, the intended result would be a quicker recovery for patients and improved outcomes.”

“We are excited to show the orthopaedic industry how we are Balancing Bodies in Motion with the exciting Newton Knee technology,” said Adam Hayden, CMO and Senior Vice President of Large Joints. “Exactech is on a mission to improve patient outcomes through our unique and powerful approach to soft tissue management, and we are eager to demonstrate how all surgeons can achieve balanced results case after case.”

The Newton Knee is a dynamic platform of cutting-edge technology used with forward-thinking implants that are designed to provide optimal balance in a reproducible way. The technology is in pilot release with limited launch planned for the second half of the year. For more information, visit www.NewtonKnee.com.

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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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References:

  1. Angibaud L et al. Reliability of Laxity Acquisitions Under Controlled Load Environment During Navigated Total Knee Arthroplasty. Presented at CAOS 2022.
  2. Angibaud L et al. Reliability of Laxity Acquisitions During Navigated Total Knee Arthroplasty – Comparison of Two Techniques. Presented at CAOS 2022.

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

ExactachGPS is manufactured by Blue Ortho, a subsidiary of Exactech, and distributed by Exactech, Inc

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Media contact

Courtney Adkins
Senior Marketing Communications Manager
courtney.adkins@exac.com

Improved Shoulder Outcomes and Knee Balance Among Findings in New Exactech Research

The studies were presented at the 2022 International Society for Computer Assisted Orthopaedic Surgery (CAOS) annual meeting.

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GAINESVILLE, Fla. (June 29, 2022) – Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, today announced new clinical outcomes data and scientific research, showcasing the power behind the company’s platform of Active Intelligence® technologies. The studies were presented at the 2022 International Society for Computer Assisted Orthopaedic Surgery (CAOS) annual meeting.

Leading the podium for Exactech was a first-of-its-kind clinical outcomes study of navigated shoulder arthroplasty that showed reduced postoperative complications, revision rates and adverse events.1 Based on two-year minimum clinical outcomes collected on both anatomic and reverse total shoulder arthroplasty patients through the world’s largest single-shoulder prosthesis outcomes database, the study demonstrated that ExactechGPS®-navigated groups experienced improved clinical outcomes compared to non-navigated groups.

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...These powerful new findings highlight the impressive work Exactech is conducting with smart technology...
Darin JohnsonExactech President
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Additional shoulder research featuring the Equinoxe® Planning App highlighted the benefits of machine learning processes for preoperative planning. Results of two studies2-3 show increased accuracy in placement of bony landmarks with these automated techniques when compared to manual placement, which could lead to consistency in anatomic measurements from patient to patient.

The Newton™ Knee platform was also showcased in five new research studies. Patients who have received a well-balanced knee replacement demonstrate significantly superior clinical outcomes compared to unbalanced patients,4 and while there are varying techniques, the Newton Knee provides highly consistent balance assessment under load before any femoral resections have been performed.5-6 In addition, the Newton Knee regularly showed significantly higher reliability in achieving balanced compartmental gaps, which illustrates improvements in balance over conventional techniques.7

Exactech research also demonstrates the ability for surgeons performing a Newton Knee to consistently execute a balanced knee regardless of their experience or background.8-9 While achieving balanced flexion/extension gaps traditionally comes with a learning curve of surgical experience, this new research showcases the outcome-improving potential of this exciting and differentiated technology for all surgeons.

“These powerful new findings highlight the impressive work Exactech is conducting with smart technology,” said Darin Johnson, Exactech President. “At CAOS, we presented improved short-term functional outcomes research, with thousands of patients, leveraging our GPS technology for shoulder. This, combined with the rich array of pre-clinical discoveries regarding the ground-breaking Newton Knee, provide continued support of the science behind our powerful suite of Active Intelligence, designed to enhance surgeon decision-making and ultimately help provide better patient outcomes.”

For more information on our smart solutions, visit www.AIExactech.com.

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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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References:

  1. Greene AT et al. Two-year clinical outcomes of total shoulder arthroplasty performed with a computer navigated surgery system. Presented at CAOS 2022.
  2. Greene AT et al. Surgeon vs. semi-automated software measured assessment of glenoid retroversion. Presented at CAOS 2022.
  3. Daviller C et al. Automatic reference axis placement via Friedman’s approach using deep learning algorithms. Presented at CAOS 2022.
  4. Golladay GJ et al. Are Patients More Satisfied With a Balanced Total Knee Arthroplasty? The Journal of Arthroplasty. Volume 34, Issue 7, Supplement, July 2019 (S195-S200).
  5. Angibaud L et al. Reliability of Laxity Acquisitions Under Controlled Load Environment During Navigated Total Knee Arthroplasty. Presented at CAOS 2022.
  6. Rueff M et al. Intraarticular Quasi Constant Force Tension in Total Knee Arthroplasty Regardless of Joint Gap and Knee Size. Presented at CAOS 2022.
  7. Angibaud L et al. Reliability of Laxity Acquisitions During Navigated Total Knee Arthroplasty – Comparison of Two Techniques. Presented at CAOS 2022.
  8. Angibaud L et al. Improved Mediolateral Gap Balance Achievement with Instrumented Navigated Total Knee Arthroplasty Compared to Conventional Instrumentation. Presented at CAOS 2022.
  9. Angibaud L et al. Ability to Achieve Mediolateral Gap Balance with Instrumented Navigated Total Knee Arthroplasty – A Review of the First 150 Cases. Presented at CAOS 2022.

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

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Media contact

Nancy Walsh
Director, Marketing Communications
nancy.walsh@exac.com

Anatomic versus Reverse, the Debate Continues

A commentary on “Comparison of complication types and rates associated with anatomic and reverse total shoulder arthroplasty” by Parada et al from JSES 2021

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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″ link=”url:https%3A%2F%2Fstaging.exac.com%2Fsurgeon%2F16954%2Fshoulder%2Flexington%2Fky%2F40509%2Fsajadi-kaveh%2F” alignment=”left” css=”%7B%22default%22%3A%7B%22font-family%22%3A%22Roboto%22%7D%7D”]Kaveh R. Sajadi, MD
Kentucky Bone & Joint Surgeons[/us_iconbox][us_separator]

There can be no doubt that total shoulder arthroplasty (TSA) is a successful operation that improves the lives of patients. Shoulder arthroplasty is increasing in frequency due in part to its success as well as the introduction of the reverse shoulder replacement (rTSA), which offers solutions to problems without previous good options. In fact, rTSA is now performed more frequently than anatomic TSA (aTSA), and sometimes the indications for one versus the other (previously quite distinct) may overlap, leading to debates about optimal implant choice. Unfortunately, with any surgery comes complications which can certainly impact outcomes and negatively effect quality of life. The authors of this study, Drs. Parada et al, sought to determine the types of failure modes of shoulder replacement and the differences in these between aTSA and rTSA.

This study is a retrospective cohort comparison using an international database of patients who received a single-platform shoulder arthroplasty system. Patients were treated by 40 different fellowship-trained surgeons and 2224 aTSAs and 4158 rTSAs were included, while revisions were excluded. These were reviewed for the incidence, type, and timing of complications. Complications and revisions were separately analyzed. Overall, the mean age of aTSA patients was significantly younger than rTSA, as would be expected. For aTSA, the overall complication rate was 10.7% with a 5.6% revision rate. The most common complications were rotator cuff tear/subscapularis failure in 3.1%, aseptic glenoid loosening in 2.5%, infection in 1.3%, and pain in 1.1%. For aTSA, the most common reasons for revision were aseptic glenoid loosening, rotator cuff/subscapularis failure, and infection. For rTSA, the overall complication rate was 8.9% with a 2.5% revision rate. The most common complications were acromial/scapular stress fractures in 1.7%, instability in 1.4%, pain in 1.2%, and infection in 0.9%. The most common reasons for revision were instability, infection, and aseptic glenoid loosening.

When compared head to head, rTSA had significantly fewer complications (aTSA 10.7% v rTSA 8.9%, p=0.0434), due to significantly fewer rates of aseptic glenoid loosening despite higher rates of instability and humeral fracture. The overall revision rate was also significantly less in rTSA (aTSA 5.6% v rTSA 2.5%, p<0.0001). There was a significantly lower rate of aseptic glenoid loosening but a higher rate of instability.

Patients were treated by 40 different fellowship-trained surgeons and 2224 aTSAs and 4158 rTSAs were included, while revisions were excluded.

The authors are to be commended for this study which adds greatly to the knowledge base on the incidence and types of shoulder arthroplasty complications. This is very helpful when discussing the potential risks and benefits of shoulder arthroplasty with patients. The authors note in their discussion that the complication rates in this paper compare very favorably with older reports of high complication rates with rTSA, in part due to increased surgeon experience and improved implant design.

Historically, rTSA was introduced as a treatment option for patients with rotator cuff tear arthropathy, or end-stage osteoarthritis combined with an irreparable rotator cuff tear as aTSA in these patients is contraindicated due to high failure rates. With its great success, indications for rTSA have expanded to include revision shoulder arthroplasty, proximal humeral fractures and fracture/dislocations, inflammatory arthropathies, and even patients with an intact rotator cuff but advanced glenoid wear or in elderly patients. It is generally held that a well-performed aTSA with an intact rotator cuff will outperform a rTSA, but subscapularis healing does not always occur and rotator cuff tears develop even without trauma as the shoulder (and patient) ages.

In some clinical settings, aTSA and rTSA are both a viable option for the patient and understanding the different complication rates and their frequencies will help surgeons better counsel their patients to determine the appropriate implant. Predictive analytics, utilizing machine learning and large patient databases such as this, may further help with this decision-making. Predict+ is such a software. Predict+ utilizes a few simple questions regarding the patient’s pain, their demographics, diagnoses, comorbidities, and range of motion to apply algorithms tested through machine learning to “predict” the patient’s expected improvement in range of motion and function with aTSA and rTSA and provides their predicted complication rates and types. This, in effect, personalizes the results of this paper to an individual patient. This information, combined with preoperative planning and intraoperative navigation to optimize implant placement, can lead to reproducibly improving outcomes and reducing complications. The future of shoulder arthroplasty may be upon us.

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References

  1. “Comparison of complication types and rates associated with anatomic and reverse total shoulder arthroplasty.” Stephen A. Parada, MD, Pierre-Henri Flurin, MD, Thomas W. Wright, MD, Joseph D. Zuckerman, MD, Josie A. Elwell, PhD, Christopher P. Roche, MSE, MBA, Richard J. Friedman, MD. J Shoulder Elbow Surg, (2021) 30, 811-818.
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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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Samantha DiVirgilio
Marketing Communications Manager
Samantha.divirgilio@exac.com