IMPACT OF GENIUM MICROPROCESSOR CONTROLLED KNEE ON AMBULATION, MOBILITY, ACTIVITIES OF DAILY LIVING AND QUALITY OF LIFE OF ACTIVE TRANSFEMORAL AMPUTEES: A SYSTEMATIC REVIEW Milana Mileusnic1, Lena Rettinger1, M. Jason Highsmith2 and Andreas Hahn1 1
2
Department of Clinical Research and Services, Otto Bock HealthCare Products GmbH, Austria
Extremity Trauma & Amputation Center of Excellence. U.S. Department of Veteran Affairs, Tampa, FL
INTRODUCTION In 2011 a new advanced hydraulic microprocessor controlled knee (MPK) Genium was introduced in the market. New sensors, algorithms and technical solutions enable the knee to offer a range of new functions to lower limb amputees. The objective of this review was to evaluate the effect of the knee on ambulation, mobility, activities of daily living and quality of life in active transfemoral amputees. METHODS The systematic review was conducted according to the Prisma Guidelines and recommendations of the State-of-Science Evidence Report Guidelines of the American Academy of Orthotists & Prosthetists. Three reviewers conducted the quality assessment independently. RESULTS Twelve articles were identified as appropriate and included in the review. They report of transfemoral amputees (MFCL-3 and 4) transitioning from CLeg to Genium (or comparable device X2). In terms of quality, all included articles scored ‘high’ for external validity, while internal validity varied with most articles rated as ‘high’ and ‘medium’. Eight articles focused on ambulation, in particular on level walking, stairs and ramps1-9. In addition to reporting results of motion analysis, several clinical tests have also been conducted. During level walking, improved toe clearance and reduced speed-dependency of maximum knee flexion angle are reported in the swing phase 3. A more physiological gait pattern is also reported during stance phase where larger knee flexion angle was measured1. New stair ascent function resulted in 7080 percent of the subjects being able to ascend stairs reciprocally1,2,8. This resulted in more physiological hip and knee movement on the prosthetic and sound side1,4. Gait analysis on ramps showed increased maximum knee flexion angle and foot clearance similar to those measured on sound side2,5,8. New standing function resulted in significantly more loading on the prosthetic side during standing on ramps3. Two articles addressed the effect of Genium on mobility10-11. Four square step test and Amputee Mobility Predictor results significantly improved with Genium use. Effect of Genium on activities of daily living was reported in
three articles6,11,12. A validated, performance-based outcome Short form Continuous Scale - Physical Functional Performance (CS-PFP10) was significantly improved, particularly in the subcategories of endurance, balance and upperbody flexibility11. Perceived safety and difficulty when performing forty-five meaningful activities of daily living showed clinical relevant results for Genium6,12. Two articles evaluated the effect of Genium on quality of life6,10. Significant improvement was measured on Prosthetic Evaluation Questionnaire evaluating prosthesisrelated quality of life10. DISCUSSION The results suggest increased efficacy of Genium in comparison to C-Leg in the areas of ambulation, mobility, activities of daily living and quality life. REFERENCES 1. Aldridge Whitehead JM, et al. Clin Orthop Relat Res; 472, 3093-3101, 2014. 2. Bell EM, et al. Clin Biomech; 33, 26-31, 2016. 3. Bellmann M, et al. Arch Phys Med Rehab; 93, 541-549, 2012. 4. Bellmann M, et al. Biomed Tech; 57, 435-444, 2012. 5. Lura DJ et al. Clin Biomech; 30, 175-181, 2015. 6. Highsmith MJ, et al. Technol Innov; 18, 139-150, 2016. 7. Highsmith MJ, et al. Technol Innov; 18, 151-157, 2016. 8. Highsmith MJ, et al. Technol Innov; 15, 359-368, 2014. 9. Hahn A, et al. Medicine; 95(45), e5386, 2016. 10. Highsmith MJ, et al. Technol Innov; 15, 369375, 2014. 11. Highsmith MJ, et al. JRRD; 53, 753-766, 2016. 12. Kannenberg et al. JPO; 25, 110-117, 2013. DISCLOSURE Milana Mileusnic, Lena Rettinger and Andreas Hahn are affiliated with Otto Bock Healthcare Products. Authors are solely responsible for the contents of this report. 99