Blueprint Mixed Reality (MR) is a software solution that endows shoulder arthroplasty surgeons with the ability to reference and interact with a holographic representation of their pre-operative plan during surgery. The mixed-reality tool is comprised of a Microsoft HoloLens 2 headset, orthopedic device maker Stryker’s Blueprint MR software, and a peripheral display for the surgical team to see what the surgeon sees during the procedure.

During a Blueprint MR shoulder replacement, the surgeon accesses 3D holograms of patient anatomy and the planned implant configuration. The surgeon can manipulate the 3D images in the operating room using hand gestures and voice commands to inspect the anatomy, build insight into planned implant configuration, and inform surgical execution.

The mixed-reality tool was designed for all cases from an A1 glenoid to a revision case. Stryker says the technology is useful for novice and expert surgeons to better understand glenoid, humeral, and soft tissue deformities while learning patient pathology. The company also claims glenoid implant positioning and pre-operative surgical plan replication is more accurate than standard glenoid techniques.^1,2

Shortly after obtaining U.S. Food and Drug Administration (FDA) clearance, the first shoulder replacement surgeries using Blueprint MR took place in mid-January 2024. The surgeons performing these first procedures were Dr. Joaquin Sanchez-Sotelo, M.D., Ph.D., consultant and professor of Orthopedic Surgery at Mayo Clinic in Rochester, Minn., and Dr. George Athwal at St. Joseph’s Health Care London, Canada.

“Mixed reality technology offers important benefits to patients,” Dr. Sanchez-Sotelo, who is one of the Blueprint design surgeons, told the press. “This technology allows the surgeon to plan and execute the surgery based on precise images of the patient’s shoulder, thereby minimizing the risk of improper placement of the implant. This is individualized care tailored to each patient’s anatomy.”

Stryker’s holographic tool for shoulder replacement surgery is one of the many innovations for the specialty—other major orthopedic device manufacturers invest heavily in the complex surgery.

Exactech: Equinoxe and Predict+

The Equinoxe shoulder platform turned 20 this year—in 2004, Exactech, its maker, celebrated the first Equinoxe anatomic shoulder implantation. A reverse option—which can be more effective for patients with rotator cuff tear arthropathy—followed in 2007. The platform fracture option arrived in 2010, followed by augmented glenoid implants a year later. 2014 saw the Humeral Reconstruction Prosthesis for complex shoulder cases with significant humeral bone loss, a first-of-its kind in the shoulder market.

The platform also features the Preserve humeral stem, a stemless glenoid implant, a small reverse implant, and the Ergo instruments.

“Every product and technology that is part of the Equinoxe system is developed through the eyes of a surgeon, with the goal of solving a true unmet clinical need,” Exactech’s VP of marketing, Extremities, Emery Patton told ODT. “Since the Equinoxe system was launched 20 years ago, we have been strategically building our product lines to now having the most complete solutions, with innovative options that have been life-changing for patients. The differentiator is Equinoxe is the most studied shoulder; we have the largest single prosthesis database in the world, which has generated 300+ published papers.”

“This focus has enabled us to develop many first-to-market products, such as the Humeral Reconstruction Prosthesis and ExactechGPS navigation,” Patton went on.

ExactechGPS debuted at 2014’s American Academy of Orthopaedic Surgeons Annual Meeting. A real-time, patient-specific solution for guided surgery, its launch coincided with the 20th anniversary of the company’s knee system. Surgeons could use it to better understand knee anatomy with instant data and imaging, in order to have a visual reference for bone removal decisions and implant positioning based on anatomical structure. Two years later, ExactechGPS was used for its first glenoid preparation in a total shoulder arthroplasty.

Amid the COVID-19 pandemic in December 2020, the company launched its Predict+ patient-specific outcome predictor for shoulder replacement. Predict+ leverages predictive analytics and patient data from thousands of cases to predict the surgery’s success. The tool is one of many in Exactech’s ecosystem of smart enabling technologies, which the company dubbed Active Intelligence.

“Predict+ is a first for the orthopedics industry, using machine learning to help surgeons predict how a patient may function after anatomic or reverse arthroplasty. It allows surgeons to change the conversation with patients, in that they can show outcomes data from others with similar demographics and have a confident, unbiased discussion about what to expect from their surgery results. This unique software is another innovative addition to Exactech’s Active Intelligence ecosystem of smart solutions that empower surgeons with resources to help improve patient outcomes throughout the journey of care. Predict+ predictions are based on the Equinoxe 15,000-patient outcomes database, which powered a recent published study—the first of its kind in orthopedics—that showed Predict+ creates fair and accurate outcomes predictions for shoulder arthroplasty patients of different ethnicity, sex, and age,” explained Patton.

The study, which was recently published in the Journal of Shoulder and Elbow Surgery,³ sought to address the bias in artificial intelligence (AI) clinical predictions that can negatively impact decision groups because those patients are underrepresented in training data. The study quantified the accuracy of Predict+ when predicting outcomes for anatomic and reverse total shoulder replacement in over 8,000 patients.

The authors reported they could identify which patient groups get fair predictions and which received unfair predictions. Predict+ was deemed fair for 98.6% of regression predictions, 99.4% of substantial clinical benefit (SCB) classification predictions, and 100% of minimal clinically important difference (MCID) classification predictions.

“Perhaps the biggest barrier to adoption of machine learning-based clinical decision support tools is the perception that they are not fair and accurate for all patients,” Exactech’s senior VP of extremities Chris Roche said in a press release detailing the study’s release. “This new clinical outcome study is the first of its kind in the orthopedic literature to evaluate if an AI prediction is fair.”

The Active Intelligence suite also includes the Equinoxe planning app for linking pre-op plans to intra-op instrument guidance and Chime app to receive and share expertise with other surgeons. Rounding out the suite is the Verasense wireless humeral sensor, which offers real-time feedback of shoulder joint compression load during surgery. As of November 2023, the company has topped 100,000 joint replacements performed with support from the Active Intelligence suite.

In May 2023, the company released the latest version of its GPS Shoulder technology following its first surgery being performed in the United Arab Emirates. The next-generation GPS Shoulder included an upgrade to the user interface, visualization tools, and additional views. It also featured verification of final implant placement for reverse and anatomic shoulder surgeries, integration with Ergo instrumentation, and wireless care report transmission capability.

“Exactech has launched some very innovative products and technologies over the course of 20 years, based on its proven platform system. Not only have we developed transformative implants such as the Humeral Augmented Tray and the Laser Cage Glenoid that can make a huge difference in both straightforward and challenging cases, we have also continued to add shoulder solutions to our Active Intelligence line, including the Equinoxe Planning App, ExactechGPS navigation, Predict+, and Chime Clinical Exchange App. We are fortunate to have a robust pipeline over the next five years that includes implants and smart solutions that will help surgeons treat patients more effectively,” said Patton.

Zimmer Biomet: Legacy and Identity

Zimmer Biomet has been developing shoulder systems for over four decades. As such, its portfolio of shoulder replacement implants is vast:

• Anatomic: Alliance glenoid, Anatomical Shoulder Domelock and combined systems, Comprehensive convertible glenoid and total shoulder systems, Sidus stem-free shoulder
• Reverse: ASHCOM shoulder, Comprehensive reverse shoulder system and augmented baseplate, Comprehensive convertible glenoid system, Trabecular Metal reverse shoulder
• Fracture: Anatomical shoulder fracture system, Comprehensive fracture system
• Revision: Comprehensive segmental revision system
• Other: Anatomical Shoulder combined and inverse/reverse systems, Trabecular Metal humeral stem and glenoid fixation

“Zimmer Biomet’s shoulder portfolio covers the entire continuum of care,” Nnamdi Njoku, president, Sports Medicine, Surgical, Upper Extremities & Restorative Therapies at Zimmer Biomet, told ODT. “In addition to our long clinical heritage in shoulder arthroplasty, ZB has solutions for the most challenging clinical scenarios faced by surgeons such as severe glenoid bone loss, revision, and limb salvage.”

The Sidus stem-free shoulder entered Europe in 2012 and received U.S. Food and Drug Administration (FDA) clearance in 2018. The company presented it as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation. It was designed to anatomically restore a patient’s anatomy, preserve bone stock, and allow for better outcomes.

The company’s Identity shoulder for anatomic, reverse, and revision replacement obtained FDA clearance in September 2022. The Identity shoulder lets surgeons personalize humeral head inclination, version, and offset during surgery. It expands on the traditional onlay and inlay reconstruction used in reverse shoulder replacement with eight humeral tray combinations. Inlay and onlay are two different reverse shoulder prosthesis designs. The inlay design is implanted centrally on the humerus to match surrounding anatomy with a fit that leaves it flush with surrounding cartilage. An onlay design rests above the anatomic neck resection.

The new configurations allows more options to align the humerus with the glenoid. Identity also allows for 5 mm of additional joint space below resection, giving surgeons more to work with should a revision be needed in the future. Identity’s Alliance glenoid component also touts a Trabecular Metal center post. The company’s Trabecular Metal is composed from elemental tantalum with properties similar to bone, with an open, engineered, and interconnected pore structure to foster biological fixation and vascularization.

“Identity Shoulder provides the surgeon several ways to adapt the implant to an individual patient’s anatomy, with proprietary technology for soft tissue balancing and tensioning,” said Njoku. “During reverse shoulder replacement, the surgeon can lateralize the humerus without affecting arm length, which fine tunes deltoid tension to help optimize range of motion. During anatomic replacement, the surgeon can vary inclination and dial in head offset for a precise center of rotation restoration. The surgeon can also convert from anatomic to reverse replacement without disturbing a well-fixed stem.”

Within Zimmer Biomet’s suite of smart, enabling technologies dubbed ZBEdge is its Signature ONE surgical planning system for shoulder arthroplasty, which the company introduced in March 2021. Signature ONE provides a 3D image-based approach to pre-op visualization, surgical planning, and creation of patient-specific guides.

The planning tool features backside contact and 3D-measurement tools. Lateralization reference points help to preserve glenoid bone, and quick changes from non-augmented to augmented components for further preservation. The system can visualize inferior Glenosphere offset to improve range of motion, as well as visualize the length of the central screw.

Once the surgical plan is approved, guide creation can occur for accurate pin placement. A glenoid model is displayed for visual confirmation during surgery, with a depth control arm for accurate glenoid depth reaming as well as a baseplate orientation and screw guide.

“ZB seeks to help solve problems surgeons face through continued investment into our implant portfolio and enabling technologies that document pre-treatment function, support surgical planning, and capture post-op patient function,” said Njoku. “We are currently developing additional shoulder technology we hope to announce in the near future.”

Look Over Your Shoulder

Shoulder device makers may wish to enlist the help of a manufacturing partner for their shoulder devices, particularly if their products incorporate innovative materials, require a multi-step manufacturing process, or require complex assembly that can’t be afforded in house. In order to gain more insight on manufacturing partnerships with shoulder technology makers, over the past few weeks ODT spoke to Lynne Kelly, VP of marketing at Avalign Technologies.

The company’s orthopedic division manufactures implants and instruments for orthopedic, spine, and trauma applications.

Avalign’s shoulder manufacturing business includes shoulder stems, humeral stems, and glenoid implants. The company also holds a patent for its Thortex spherical and asymmetric porous coating for cementless titanium or cobalt chrome implants, which includes humeral stems and glenoids. The rough surface created by the coating assists with initial fixation and allows bone to grow into the device for long-term stability. These are powered by the company’s precision machining and metal injection molding services, along with other full-service options.

Here’s what Kelly had to say:

Brusco: What manufacturing support does Avalign offer for shoulder technology OEMs?

Kelly: Avalign has all the support an OEM would expect, if they were to do everything in-house. We have built and staffed Avalign with people who have significant OEM experience, especially in leadership and technical roles.

We deeply understand the industry, our customers, and their customers and patients. We have a full complement of engineers (product, process, and quality) and programmers with deep experience in design for manufacturability (DFM), quality, and cost for orthopedic products—especially shoulder products, where we enjoy significant market share. We have expertise in regulatory, certified program managers, production planners, supply chain professionals, and logistics experts who fully understand the orthopedic distribution model. So, we can help our OEM customers with any aspect of development, launch, and lifecycle planning and execution.

Brusco: How does this support benefit shoulder device makers?

Kelly: Ultimately, it’s about reliable and predictable speed to market with the ability to scale for launch and post-launch growth.

We can engage with OEMs at any stage of their product lifecycle. Our primary business is contract manufacturing but we can on-ramp with a customer at any point on the road to contract manufacturing. At one end of the spectrum, we can provide outsourced manufacturing for an existing product or a fully scoped, designed, and specified new product. At the other end, we can provide full manufacture of record design, development, and regulatory ownership. In between, we often do collaborative design and development, rapid prototyping, risk retirement, and product-process optimization. We find the earlier we are engaged in this journey with our OEM customers, the more benefits they will derive.

Moreover, we are one of the only CDMOs that can provide every aspect of an orthopedic implant system, including implants and coatings, fixation devices, cutting instruments, specialty German engineered instruments, cases and trays, as well as fully kitted implant banks and instrument sets. We can provide a one-stop shop for entire systems and often do, which allows for much more flexibility in set stocking and deployment for surgeon conversions.

An important aspect to any of this, however, is the ability to scale, especially for large systems. Accordingly, we continue to invest heavily in capacity, state-of-the-art technology, resources, and infrastructure, including dedicated capacity and resources for large programs. This investment accelerates speed to market and scale up.

Brusco: Can you speak on the coatings side of your business, and why the offering is useful and important for shoulder technology and its makers?

Kelly: Porous coatings have become a staple in orthopedics and especially in shoulder arthroplasty, both on humeral and glenoid components. Our ability to provide proven, proprietary porous coatings, as well as the upstream and downstream processes for a complete implant, is a significant advantage for our OEMs.

Moreover, we have over 30 years of coating expertise and have produced over 2 million porous coated implants. Our proprietary porous coating technology is well documented in our FDA master file and allows customers to leverage our data and expertise to increase their speed to market. As one of only a few CDMOs with proprietary porous coatings, including deep expertise and significant investments in highly specialized equipment, technologies, and processes, we can help OEMs bring porous coated products to market. 

References

1. bit.ly/odtshoulder01241
2. Joseph Iannotti, MD, PhD, Justin Baker, PhD, Eric Rodriguez, BS, John Brems, MD, Eric Ricchetti, MD, Mena Mesiha, MD, and Jason Bryon, MS. Three-dimensional preoperative planning and a novel information transfer technology improve glenoid component positioning.
3. bit.ly/odtshoulder01242