WorkCompWire
Full article on workcompwire.com
Jan Saunders, CPO, Clinical Director Prosthetics, Paradigm
Michael Choo, MD, FACEP, FAAEM, Chief Medical Officer, Workers’ Compensation, Paradigm
Workplace limb loss injuries dramatically change the lives of everyone involved, including family members, coworkers, communities, and above all, the injured workers themselves. Restoring function and quality of life requires the highest levels of support and the expertise of an experienced, specialized care team. In the area of prosthetics, this means selecting and fitting the device that is most appropriate for the given level of limb loss and the injured worker’s desired lifestyle and activity level.
For certain challenging and complex limb loss cases, the evolution of osseointegration-based procedures and prosthetic devices offers exciting potential for optimizing function with improved mobility, limb strength, balance, and comfort. What’s more, osseointegration can result in tremendous long-term value and savings opportunities over the life of a claim, thanks to the elimination of socket replacements and adjustments, along with the skin complications typically associated with socket-based prosthetics. However, it is important to understand that osseointegration is not for everyone, and this novel surgical procedure has clear indications and contraindications to ensure its availability is limited to the most appropriate segment of the 6,000 injured workers who require amputations and prosthetics each year.1
To make informed and appropriate decisions that truly improve lives, workers’ comp stakeholders need a comprehensive understanding of benefits, risks, and costs for the wide range of available prosthetic options—including the role of osseointegration in limb loss management. Ultimately, determining the best strategy for each injured worker requires a highly personalized, evidence-based approach that explores all available solutions.
The development and challenges of traditional prosthetics
The use of prosthetic limbs dates back thousands of years, with the earliest evidence coming in the form of an artificial toe found in an ancient Egyptian tomb.2 Although early prosthetics were often primarily decorative, ongoing research and development of prosthetic technology over the years eventually led to the use of plastics and other synthetic materials that allowed for more lightweight and functional designs. Today, prosthetics have become highly advanced, incorporating myoelectric technologies, microprocessors, robotics, and advanced cosmetic materials that can more closely mimic limb mobility and appearance.
Even with these improvements, it is still standard for modern-day prosthetics to be fitted with a socket interfacing with skin of the residual limb. Although socket technology and materials have improved, there are still inherent comfort challenges and functional compromises to this method, including:
- Poor fit due to residual limb changes in volume
- Loss of sensation, including hot and cold, within the socket
- Discomfort and skin irritation when not maintaining proper fit
- Reduced mobility and function due to lack of integration with the musculoskeletal system
- Susceptibility to skin complications—including skin breakdown, bacterial growth, and infection—if not properly fitted and maintained
Furthermore, socket prostheses typically require frequent replacements as the residual limb changes in size, shape, and volume—and they can only be adjusted to a certain point before requiring replacement. What’s more, research has shown that up to 82% of lower limb amputees develop socket-related complications, despite long-term and often costly efforts.3
Understanding the potential of osseointegration
Osseointegration (OI) is a surgical technique that allows anchoring a prosthetic device directly to the living bone of the residual limb. This method is based on research dating back to the 1940s, which demonstrated the viability of a direct structural and functional connection between living bone tissue and the microporous surface of metallic implants.4
In the U.S., the first documented surgery using OI for direct skeletal attachment to a prosthesis was at Rancho Los Amigos Hospital in the early 1970s. With about 1,500 patients to date having received OI for limb amputations worldwide, there is a growing optimism for OI in the U.S. Today, there are two popular OI systems: Screw-Fixation and Press-Fit Fixation. Currently, the Screw-Fixation system with FDA’s PMA or premarket approval is the OPRA implant device which stands for “Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Device” and this was granted approval in December 2020. Within the Press-Fit Fixation group, there are different types of implants—ILP, OPL, and POP—which are currently undergoing clinical trials to be reviewed for FDA approval. Today, there is a steady growth in the adoption of osseointegration by multiple centers in the United States, with comprehensive limb preservation programs and interdisciplinary teams.
Because the prosthesis is directly integrated with the musculoskeletal system, osseointegration offers exciting possibilities for limb replacement, including improved function and better quality of life. Specific benefits of osseointegration include:
- Direct engagement of surrounding musculoskeletal tissue that promotes more normal biomechanical control that enhances bone and muscle health
- Gaining of osseoperception, which is the ability to sense the quality of the surrounding contact surface and environment via tactile sensory transmission via the mechanoreceptors in the residual limb
- Enhanced range of motion and a more natural gait, associated with longer and more efficient periods of activity
According to Paradigm’s review of the published literature, osseointegration-based prosthetic users reported two times longer prosthesis use and 61.5% higher quality of life scores on the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA).5
Exploring cost considerations for prosthetics
For plan administrators and payers in workers’ compensation, questions about value and cost effectiveness naturally come with innovations in medical technology—and this is certainly true in the world of prosthetics and limb loss management. Newer approaches, such as osseointegration, will have higher up-front spend compared to established procedures and more conventional treatment approaches. But for those very unique and challenging limb loss-injured workers with barriers to successful socket-based prosthetic adoption, stakeholders must also factor in potential long-term functional outcome benefits with those initial medical expenses that can impact overall total cost of care savings opportunities. In the case of socket-based prosthetics, while the initial cost often ranges from $15,000-$16,000,6 this does not include ongoing maintenance and replacement expenses frequently associated with this socket-based prosthetic longer-term expense category.
For example, one significant driver for socket replacements is the weight of the individual. A person who weighs 300 pounds will have volume changes three times faster than someone who weighs 100 pounds, requiring frequent adjustment or potential replacement. And weight gain or loss of more than 15 pounds can require the need to replace the socket. Depending on the age and active lifestyle of the amputee, this and other factors can result in high continued costs over the life of the claim.
While osseointegration-based prosthetics may have higher initial spending, with surgical procedures costing between $50,000 and $70,000,6 the claim cost over the life of the implant can be substantially less. Prosthetics using osseointegration procedures can be associated with fewer adjustments and reduced breakdowns and health concerns.
When the most appropriate injured worker is identified for the osseointegration option, this novel solution can result in life changing improvements in function and quality of life, while still delivering value and total cost of care savings to employers, administrators, and payers. As just one example, in an analysis for a workers’ compensation carrier, a 23-year-old female who lost her leg above the knee was dealing with fitment and skin irritation from her socket-based prosthetics. According to the analysis, approving osseointegration surgery would result in lifetime savings of more than $650,000 over the life of the claim.6
The importance of individualized, expert-driven prosthetic care management
Achieving a positive outcome for the serious injuries that result in limb loss requires a highly skilled team with the expertise to make objective and appropriate care decisions. Whether the best solution involves a socket-based device or osseointegration, a thoughtful, holistic approach is essential to achieving the best outcome.
Your relationship with an implant management partner ultimately comes down to having trust. With the full range of technology and devices available today, you need to be able to trust that recommendations are based on what is best and most appropriate for the specific needs of the injured workers and their families.
Sources:
- https://www.bls.gov/opub/ted/2020/machinery-involved-in-58-percent-of-work-related-amputations-in-2018.htm
- https://magazine.medlineplus.gov/article/prosthetics-through-the-ages
- https://pmc.ncbi.nlm.nih.gov/articles/PMC9636812/#CR56
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8956382/
- Innovations in Care Management Outcomes, Osseointegration in Amputation Care, Paradigm, 2022
- Paradigm Data
About the Authors
Dr. Michael Choo is Paradigm’s Chief Medical Officer, Workers’ Compensation. He maintains the company’s relationships with its network of consulting physicians and centers of excellence, and is responsible for enhancing clinical operations and leading outcomes research and development.
Before coming to Paradigm, Dr. Choo was President and CEO of CHM Regional Health System in Wilmington, Ohio, where he oversaw its transition from county-owned nonprofit to a private-equity-funded for-profit hospital.
Dr. Choo holds his BA and MD from Boston University’s accelerated six-year honors program in medicine, as well as an MBA from the University of Tennessee’s Haslam Graduate School of Business. He is a senior oral board examiner for the American Board of Emergency Medicine, a fellow of the American College of Emergency Physicians, and a fellow and board member of the American Academy of Emergency Medicine.
Jan A. Saunders is a nationally certified prosthetist/orthotist with more than 40 years’ experience. In addition to providing clinical oversight of Paradigm’s prosthetic program, which includes peer-to-peer consultation and bill review, Saunders conducts continuing education programs, participates in carrier settlement planning discussions, and provides expert testimonies and depositions.
He began his career as a prosthetic technician before attending Northwestern University in Chicago and New York University’s School of Medicine prosthetic and orthotics program. In addition to treating injured workers over the years, he owned and operated several P&O companies that were later sold to publicly traded companies.
Most recently, he was the President and Chief Clinical Officer of one of the largest multi-state, multi-clinic orthotic and prosthetic providers in the United States.
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