Beyond Unloaders: Delaying Knee OA Progression, Part II

Part 1 of this article discussed the multifaceted nature of knee osteo-arthritis (OA). This second installment explores several new conservative approaches to treating the condition that can delay progression and the need for a total knee replacement. BioniCare Therapy BioniCare from VQ OrthoCare is a clinically proven electronic-stimulation system that provides an electrical signal that stimulates joint tissue to reduce the pain and symptoms of knee OA to improve the health of the knee joint. Best results are achieved after several months of routine BioniCare use. The BioniCare system can be used independently or be incorporated into an unloader knee brace. Clinical research comparing the use of BioniCare independently or incorporated into an unloader found that BioniCare incorporated into a knee brace provides superior clinical results compared to BioniCare use alone. 5 VQ OrthoCare recommends using the BioniCare system incorporated into an unloader during the day and using the BioniCare Wrap during sleep. The greater the number of hours BioniCare is used, the faster the patient feels relief from knee OA. Use of BioniCare has been found to delay the need for a total knee replacement as its use reduces unbraced pain and improves function. Guardian Rehabilitator Technology The Guardian Rehabilitator Knee Brace provides a novel neurological gait training rehabilitative approach to the treatment of knee OA. The device has an adjustable dynamic extension assist mechanism combined with a pneumatic air bladder system to provide unloading and muscle activation while walking in the brace. These brace features enhance sensorimotor stimulation, ensure terminal extension in gait, and effectively reverse quadriceps central activation deficits (CAD) within 60 to 90 days of brace use. [caption id="attachment_259812" align="alignright" width="210"] The Rehabilitator brace.[/caption] Because gait biomechanics are shaped in the corticospinal tract of the brain, the muscle firing signals from the lower limb must be able to reach the brain to effectively rehabilitate gait muscle memory. The Guardian Rehabilitator includes the use of pneumatic unloading air bladders that also provide significant sensorimotor input to ensure that signals from the muscles coming from an improved dynamically assisted movement in the leg are able to ascend effectively to the brain to reshape an improved muscle memory gait pattern unbraced (bottom-up massed practice gait retraining). A secondary benefit of the pneumatic unloading system is that the device provides superior unloading for more severe OA patients or bicompartmental knee OA. Rehabilitator Unloading When designing OA unloaders, the conventional wisdom is that the unloader brace must be 16 to 22 inches in length to effectively unload the affected knee compartment. Traditional unloaders use the concept of a three-point lever to either pull or push the knee to unload the affected knee compartment. The strapping system or the adjustable uprights realign the knee joint to unload the affected compartment. Some companies claim a four-point lever for more effective unloading, but the strapping system or uprights are adjusted using the lever arms of the brace to realign the knee joint. The Sport Rehabilitator is only 11 inches in length. It does not use the principle of a three-point lever to unload the knee and therefore does not require the same length as traditional unloaders. When inflated, the brace’s pneumatic air bladder condyles provide direct realignment of the knee joint. For medial compartment OA, the air bladder on the lateral side of the knee joint is filled first to gently push the knee joint medially to unload the joint. The opposite side air bladder is inflated next using approximately half the amount of air used on the lateral side. When this air bladder is inflated, it creates therapeutic compression in the joint and acts like a pneumatic shock absorber to protect the joint. While most prefabricated unloaders that utilize a three-point lever system can realign the knee joint 2 to 3 degrees, the Rehabilitator has been shown to realign the knee joint using the brace’s pneumatics up to 5 degrees. The combination of the shorter brace, flexible shell, and the pneumatics of the brace design tends to be more comfortable and less intrusive than a longer leg brace and has a lower likelihood of migrating during patient use. Rehabilitator Clinical Research There are four published studies on Rehabilitator technology. 6-9 All the clinical studies evaluated unbraced Rehabilitator patient gait improvement, functional abilities, pain, and leg strength. Each patient used the brace a minimum of three hours per day for 90 days. It is the only research study analyzing knee OA unloader effectiveness where all testing was completed without the brace on the leg. After walking in the Rehabilitator for 90 days, the following improvements were identified when comparing OA patients using a Rehabilitator brace to patients who received home exercise therapy only. The Rehabilitator group demonstrated: Increased quad strength in the Rehabilitator patients of 54 percent versus a loss of 8 percent quadriceps strength for the home exercise group Increased hamstring strength of 28 percent versus no improvement in unbraced patients Forty-three percent less knee pain unbraced versus a slight increase in pain for those not in the Rehabilitator group Improved unbraced lower-leg extension (terminal extension) of 6.2 degrees versus an additional 4 percent loss of terminal extension in the exercise-only group Improved Timed Up and Go of 17 percent versus no change in the unbraced group Stair climbing 26 percent faster versus no change in the unbraced group Unbraced gait 11 percent faster as measured in the Two-Minute Walk Test versus no statistically significant change in the unbraced group Reduction in the knee abduction moment of 48 percent unbraced versus no change in the unbraced group Rehabilitator Brace Wear Time Reduction After 90 days of Rehabilitator use, the majority of patients are able to significantly reduce brace wearing time. With an average decrease in unbraced knee pain, the unloading aspect of the brace is not needed for pain management after 90 days for many daily activities. This improves patient compliance as the patient is not brace dependent to manage their knee pain. The brace continues to be used after 90 days primarily when participating in vigorous activities to protect the knee joint. Rehabilitator use after 90 days is highly recommended for a minimum of two to four hours per week to retain the neurological improvements. Wearing the brace while ambulating is recommended to retain the normalized gait biomechanics. Like a dental retainer, if the brace is not used, gait biomechanics can regress over time back to an altered gait with diminished muscle activity and increased stiffness and discomfort. Dynamic Extension Assist Differences The Levitation knee brace is a performance-enhancing device that provides dynamic extension assist of up to 200 inch-pounds. The dynamic extension assist is intended to reduce the effort required of the quadriceps muscles. It is estimated that using the dynamic extension assist device that 40 pounds are taken off the load placed on the knee joint. The Guardian Rehabilitator uses approximately five inch-pounds of extension assist by comparison. The extension assist in a Guardian Rehabilitator is designed to simply restore lost terminal extension in gait not to substitute for weakened quadricep power. By restoring terminal extension with a lower-leg extension assist, significantly greater neurological quadriceps firing occurs with every step taken in the brace. After 90 days of brace use, gait biomechanics are normalized, and the patient is activating the quadriceps unbraced to maintain unbraced improvements in knee pain and function. The extension assist is designed to normalize gait biomechanics using a gait retraining neurological approach to delaying the progression of knee OA. The extension assist is not intended to reduce the load on the quadriceps, which can lead to muscle weakening over time. Instead, the extension assist is designed to strengthen the quadriceps by increasing quadriceps firing with each step taken in the brace. Apos Biomechanical Device Apos is a novel noninvasive shoe that uses strategically placed convex pods on the sole of the Apos shoe to alter the patient’s center of pressure (COP) at the foot at weight bearing. The altered COP shifts the ground reaction force trajectory, significantly reducing the load on the knee joint over time. With repeated use there is a neuromuscular retraining effect that results in healthier walking patterns with diminished symptoms. 10 In medial compartment knee OA, shifting the biomechanical elements laterally causes a lateral shift of the COP that leads to a reduction in knee adduction moments. 11 Furthermore, shifting the biomechanical elements anteriorly causes an anterior shift of the COP and reduces knee flexion moment. 1 Reduction in these forces reduces biomechanical knee joint degradation. [caption id="attachment_259811" align="alignright" width="247"] The Apos device.[/caption] The clinician assesses the individual patient’s gait and adjusts the location of the Apos convex pods in a specific manner to reduce weight bearing pain and to retrain the patient’s gait. The convex pods create a level of controlled perturbation for neuromuscular retraining. The patient is encouraged to wear the device up to two to three hours per day while walking, standing, etc. Return visits are required to recalibrate the pods to optimize gait biomechanics over time. Clinical research found that use of the Apos gait retraining system significantly reduced the incidence of total knee replacement over a five-year period. Apos patients had a total knee replacement incidence over a five-year period of 12.6 percent compared to a control group of moderate to severe OA patients receiving traditional OA therapy with an incidence of 34.3 percent after an average of 2.4 years. More advanced-stage knee OA patients reported a 29 percent reduction in unbraced pain compared to the control group, which is believed to be one of the reasons for a lower incidence of total knee replacement. 10 Studies show an improvement in biomechanical parameters and indicators of knee OA while walking with and without the device including a reduction in knee adduction moment, 12 a reduction in knee flexion moment, 13 improvement in muscle activation, 11 and improvement in spatiotemporal gait patterns. 14,15 The improvement in biomechanical indicators was associated with improved patient-reported outcome measures, i.e., pain, functional disability, and quality of life. 16-17 Like the Guardian Rehabilitator, the Apos device is a gait retraining neuromuscular approach to knee OA intended to reduce biomechanically created wear and tear on the knee joint. Both devices provide carryover benefits unbraced, which is an indication that neurological impairments caused by knee OA have been reversed to some degree. Intermittent use of both the Apos and the Rehabilitator is recommended to maintain normalization of gait biomechanics. Delaying the Progression of Knee OA BioniCare has been clinically proven to significantly improve the overall health of the OA knee, reduce unbraced knee pain, and improve unbraced function. Using BioniCare incorporated into an unloader during the day and at night as a wrap has been shown to provide the most effective regimen for patient improvement. BioniCare has been shown to be very effective at improving knee joint health but does not appear to alter the OA gait biomechanics, which are responsible for cartilage wear and tear. However, the healthier tissue in the joint is believed to be better able to reduce biomechanical wear and tear on the knee joint. The Guardian Rehabilitator provides a gait retraining approach to reversing the symptoms of knee OA along with providing effective treatment for the neurological impairments associated with knee OA. The Rehabilitator has an adjustable extension assist mechanism that is designed to restore terminal extension of the lower limb in gait. Full quadriceps activity is restored both braced and unbraced by optimizing the loading response of the quadriceps at the ankle/foot to significantly increase quadriceps activity. The Rehabilitator uses a very different approach to extension assist therapy when compared to the Levitation knee brace. The Levitation extension assist is designed to reduce the work required by weakened quadriceps muscles to improve functional performance. The Rehabilitator takes the opposite approach in restoring lower-leg terminal extension to facilitate neurological improvements in quadriceps activity by restoring terminal extension of the lower leg during gait and eliminating quadriceps CAD. The Rehabilitator is the only new technology for the treatment of knee OA that has confirmed significant muscle strengthening as a result of device use. Apos uses the treatment strategy to redistribute weight during weight bearing away from painful areas. Apos retrains how users walk for long-term relief even when not using the device. The device is a neurological approach that creates a perturbation effect during weight bearing that with repeated use normalizes gait biomechanics. After initial treatment, intermittent use of Apos is recommended to maintain improved gait biomechanics long term. Best Practices for Knee OA Treatment There are two rehabilitative knee bracing approaches to delaying the progression of knee OA. The first is to alter gait biomechanics unbraced to reduce the degradation of the knee joint caused by the altered gait of the OA patient. The second approach is the regeneration of unhealthy tissue in the OA knee. Best practices would suggest that combining treatments to both reduce the biomechanical degenerative forces on the knee along with enhancing regeneration of healthy tissue in the knee joint would provide the optimal patient outcomes. As alternative treatment options to a total knee replacement like PRP injections or stem cell treatments to regenerate knee cartilage become more mainstream, orthotists should be familiar with and recommend complementary orthotic therapies that either significantly reduce unbraced biomechanical forces on the OA knee, or assist in regenerating healthier knee tissue to enhance patient outcomes. By combining cartilage regeneration (injections) with elimination of degenerative biomechanical forces (Rehabilitator or Apos therapy) the progression of knee OA can be significantly delayed. Recommendation: A Functional Unloader or Rehabilitative OA Device Routine use of the rehabilitative bracing therapies discussed above are required to realize positive patient outcomes. For example, the patient must be motivated to “walk their way to a healthier knee” or to routinely use the BioniCare system to realize significant improvements. For a Grade I or II patient who reports stiffness after playing golf but not daily discomfort, use of a functional unloader used during sport or other vigorous activities may provide the best treatment. Without a need for daily device use for pain management, the routine brace use needed to rehabilitate an OA leg likely will not occur. As OA progresses, the patient can be upgraded to a rehabilitative technology. For OA patients that are symptomatic on a daily basis, a more rehabilitative approach to OA knee bracing makes better sense to achieve the desired patient outcomes with a focus on delaying or eliminating the need for a total knee replacement. Any patient that has Grade III/IV knee OA would best be treated with orthotic therapy that either reduces the biomechanic forces on the knee joint unbraced or assists in regenerating healthier knee joint tissue. The obvious objective is to significantly delay or eliminate the need for a total knee replacement. A secondary benefit of a rehabilitative OA knee brace is that should the patient elect to have a total knee replacement in the future, that patient would present the surgeon with a stronger leg and normalized gait biomechanics, leading to improved postsurgical patient outcomes. BioniCare, Rehabilitator, and Apos therapies provide rehabilitative carryover benefits that support enhanced patient outcomes. Because the patient is symptomatic, there should be greater patient compliance with the therapy. The BioniCare requires significant hours of device use to generate healthier tissue; Rehabilitator and Apos require approximately 90 days of daily use of the products one to three hours per day to realize the unbraced benefits of the ambulating therapy. Summary BioniCare provides regenerative therapy after several months of device use. Clinical studies demonstrate healthier joint tissue with routine device use. Healthier joint tissue improves patient function and significantly reduces unbraced knee pain. Rehabilitator and Apos provide a gait retraining approach to reverse the biomechanic degradation of the knee joint. Normalizing gait biomechanics is clinically proven to reduce joint wear and tear. The Rehabilitator has been clinically proven to reverse the neurological impairments associated with knee OA. Use of BioniCare, Rehabilitator therapy, or Apos technologies reduce brace dependency. A rehabilitative bracing approach to knee OA provides measurable unbraced biomechanical reductions in knee wear and tear or tissue regeneration. These technologies have been clinically proven to delay the need for a total knee replacement. As healthcare plans focus on patient outcomes and savings, products like BioniCare, the Guardian Rehabilitator, and Apos will become more mainstream and likely reduce the demand for traditional unloaders, especially for Grade III/IV patients. Becoming familiar with these innovations in knee OA bracing technology is recommended to prepare our practices for the future of patient outcomes–driven brace care. John Kenney, PhD, BOCO, is the inventor of DynaPro antispasticity orthoses and holds five patents on antispasticity brace design. He is the vice president of Clinical Development, Ongoing Care Solutions/Guardian Brace. References Rice D. A., P. J. McNair, and G. N. Lewis GN. 2011. Mechanisms of quadriceps muscle weakness in knee joint osteoarthritis: the effects of prolonged vibration on torque and muscle activation in osteoarthritic and healthy control subjects. Arthritis Research and Therapy 13(5):R151. doi: 10.1186/ar3467. Dall, T. M., P. D. Gallo, R. Chakrabarti, T. West, A. P. Semilla, and M. V. Storm. 2013. An aging population and growing disease burden will require a large and specialized health care workforce by 2025. Health Affairs 32(11), 2013-20. Mordor Intelligence™ Industry Reports, Knee OA Incidence 2024 to 2029. Source: https://www.mordorintelligence.com/industry-reports/content-intelligence-market/market-size Data Bridge (2024). Global Knee Osteoarthritis Market – Industry Trends and Forecast to 2029. Source: https://www.databridgemarketresearch.com/reports/global-knee-osteoarthritis-market Hungerford, D. S., E. J. Maclaughlin, and C. M. Mines, et. al. 2013. Synergistic effect of using a transcutaneous electrical joint stimulator and an unloading brace in treating osteoarthritis of the knee. American Journal of Orthopedics (Belle Mead NJ) 42(10):456-63. Erratum in: American Journal of Orthopedics (Belle Mead NJ) 42(12):574. Cherian, J. J., A. Bhave, B. H. Kapadia, R. Starr, M. J. McElroy, and M. A. Mont. 2015. Strength and functional improvement using pneumatic brace with extension assist for end-stage knee osteoarthritis: A prospective, randomized trial. The Journal of Arthroplasty 30(5):747-53. Chughtai, M., A. Bhave, and S. Z. Khan, et. al. 2016. Clinical outcomes of a pneumatic unloader brace for Kellgren–Lawrence grades 3 to 4 osteoarthritis: A minimum 1-year follow-up study. The Journal of Knee Surgery, (8):634-8. Johnson, A. J., R. Starr, B. H. Kapadia, A. Bhave, and M. A. Mont. 2013. Gait and clinical improvements with a novel knee brace for knee OA. The Journal of Knee Surgery 26(03):173-8. Kapadia, B. H., J. J. Cherian, and R. Starr, et. al. 2016. Gait using pneumatic brace for end-stage knee osteoarthritis. The Journal of Knee Surgery (3)218-23. Hasanoglu, A. N., A. Hsu, and S. Yerra, et. al. 2023. Incidence of knee surgeries over 5 years among patients with knee osteoarthritis treated with a non-invasive, home-based, biomechanical intervention. Journal of Musculoskeletal Research 2350020. Haim, A., A. Wolf, G. Rubin, Y. Genis, M. Khoury, and N. Rozen. 2011. Effect of center of pressure modulation on knee adduction moment in medial compartment knee osteoarthritis.” Journal of Orthopaedic Research 29(11):1668–74. Haim, A., G. Rubin, N. Rozen, Y. Goryachev, and A. Wolf. 2012. Reduction in knee adduction moment via non-invasive biomechanical training: A longitudinal gait analysis study. Journal of Biomechanics 45(1): 41–5. Debbi, E. M., A. Wolf, Y. Goryachev, N. Rozen, and Amir Haim. 2015. Alterations in sagittal plane knee kinetics in knee osteoarthritis using a biomechanical therapy device.” Annals of Biomedical Engineering 43(5):1089–97. Haim, A., G. Segal, and A. Elbaz, et. al. 2013. The outcome of a novel biomechanical therapy for patients suffering from anterior knee pain. The Knee 20(6):595–99. Debbi, E. M., B. Bernfeld, and A. Herman, et. al. 2019. A biomechanical foot-worn device improves total knee arthroplasty outcomes. The Journal of Arthroplasty 34(1):47-55. Bar-Ziv, Y., Y. Beer, Y. Ran, S. Benedict, and N. Halperin. 2010. A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: A prospective controlled study. BMC Musculoskeletal Disorders. 11. 179. 10.1186/1471-2474-11-179. Reichenbach, S., D. T. Felson, and C. A. Hincapié, et al. 2020. Effect of biomechanical footwear on knee pain in people with knee osteoarthritis: The BIOTOK Randomized Clinical Trial. JAMA 323(18):1802–12. Budarick, A. R., B. E. MacKeil, S. Fitzgerald, and C. D. Cowper-Smith. 2019 Design evaluation of a novel multicompartment unloader knee brace. ASME. Journal of Biomechanical Engineering 2020 142(1):014502. Icarus White Paper. www.icarus.com Lankhorst et al. 2017. Incidence, prevalence, natural course and prognosis of patellofemoral osteoarthritis: The cohort hip and cohort knee study. Osteoarthritis and Cartilage 25(5):647–53. McGibbon, C. A., S. Brandon, E. L. Bishop, C. Cowper-Smith, and E. N. Biden. 2021. Biomechanical study of a tricompartmental unloader brace for patellofemoral or multicompartment knee osteoarthritis. Frontiers in Bioengineering and Biotechnology doi: 10.3389/fbioe.2020.604860. PMID: 33585409; PMCID: PMC7876241. Stefanik et al. 2016. Changes in patellofemoral and tibiofemoral joint cartilage damage and bone marrow lesions over 7 years: The multicenter osteoarthritis study. Osteoarthritis and Cartilage 24(7): 1160–66. Credits in order of appearance: Photograph courtesy of Guardian Brace. Photograph courtesy of Apos Health.

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Beyond Unloaders: Delaying Knee OA Progression, Part II

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