AN EVOLUTION IN TOTAL KNEE ARTHROPLASTY

Transcription

1 SENSOR-ASSISTED TKA

2 AN EVOLUTION IN TOTAL KNEE ARTHROPLASTY OrthoSensor s Sensor-Assisted TKA disposable instrument delivers evidence-based data wirelessly to an intra-operative monitor that enables surgeons to make informed decisions on ligament/soft tissue balance and implant position in real time. As a result, patients whose knees have been balanced through the use of show statistically significant improvements in joint function, pain, activity level and patient satisfaction. 1,2 is the next evolution in Total Knee Arthroplasty.

3 WHY? Mal alignment and improper soft tissue balance complications including instability, aseptic loosening and polyethylene wear cause approximately % of all premature implant failures, 3,4,8,9 burdening patients, providers and payors with high cost revision surgery. The importance of proper ligament balance, implant rotation and limb alignment to maximize implant survivorship is well understood in clinical peer-reviewed literature. Until now, decisions concerning these factors have varied based on an individual surgeon s judgement, experience and skill, as surgeons have lacked a quantifiable instrument and data to optimize their soft tissue balance and knee kinetics. advances soft tissue management from a feel-based art to a quantifiable science, thereby reducing post-op risk of pain, imbalance and instability all of which can lead to early revision and implant failure. enables surgeons to quantify ligament balance and improves surgeon skill by giving them real-time, evidence-based data. 1,2 INDEPENDENT SURGEON POLL: WHAT AREAS NEED TO BE ADDRESSED MOST URGENTLY TO IMPROVE TKA OUTCOMES? Ligament Balancing Techniques Surgeon Training and Skill Implant Alignment Factors Contributing to Infection Implant Sizing and Design Patient Compliance Other VuMedi. Access date Jan 7, Which of the following areas do you feel needs to be addressed most urgently to improve TKA outcomes? Retrieved from

4 IMPROVED CLINICAL PERFORMANCE 1,2 Patient satisfaction closely correlates with post-operative function. 1 97% of patients whose knees were balanced using reported being satisfied to very satisfied versus 82% of patients whose knees were left unbalanced (average KNEE SOCIETY (KSS) PAIN PRE-OP 6 MONTHS 1 YEAR AVERAGE : 96.4 UN AVERAGE : 87.8 UN KNEE SOCIETY (KSS) FUNCTION UN PRE-OP 6 MONTHS 1 YEAR AVERAGE : 82.4 UN AVERAGE : 68.3 post TKA patient satisfaction in peer-reviewed literature is 81%). Two years after surgery, the unbalanced cohort of patients had WOMAC ACTIVITY LEVEL yet to achieve the outcome scores set by the balanced cohort of patients just six months after surgery. Research shows that balanced knees lead to less post-operative pain, which allows for increased activity levels, and improved functional outcomes UN UN and patient satisfaction. PRE-OP 6 MONTHS 1 YEAR PRE-OP 6 MONTHS 1 YEAR AVERAGE : 10.4 UN AVERAGE : 17.9 AVERAGE : 66.8 (LIGHT TO MODERATE LABOR) UN AVERAGE : 47.6 (SEMI-SEDENTARY) PATIENT SATISFACTION ROBERTSSON, ET AL. BULLENS, ET AL. NOBLE, ET AL. MANNION, ET AL. BOURNE, ET AL. (TKA) BOURNE, ET AL. (TKA vs THR) 81% Average Patient Satisfaction BECKER, ET AL. MOHAMED, ET AL. WILLIAMS, ET AL. TURCOT, ET AL. HARRIS, ET AL. PARVISI, ET AL. UN PATIENTS 97% PATIENTS MULTICENTER STUDY 2-YEAR RESULTS (2015) KNEES REDUCED POST-OPERATIVE PAIN INCREASED ACTIVITY LEVEL IMPROVED FUNCTIONAL OUTCOME IMPROVED PATIENT SATISFACTION

5 BENEFITS OF SENSOR-ASSISTED TKA You can t change what you can t measure. quantifies soft tissue balance to improve outcomes for your patients. Such improvements in quality of care and patient outcomes are vital for CMS, payor and patient-performance measures by: Reducing technical variability and surgery outliers 5,7 Reducing risk of pain and instability which can contribute to implant failure and early revision 2,6 Increasing knee function, activity levels and patient satisfaction 1,2,6 UN is compatible for use with the following knee systems: *No capital investment required

6 RUNNER-UP MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY Which Medical Device Medical Device of the Year ORTHOSENSOR ORTHOSENSOR Silver Application Award 2015 Best of Sensors Expo Awards Gold Application Award 2014 Best of Sensors Expo Awards Finalist 2013 Medical Device Manufacturer of the Year Award Bronze Application Award 2013 Best of Sensors Expo Awards Runner-Up Which Medical Device of the Year Award Gustke K, Golladay G, Jerry G, Roche MW, Elson LC, Anderson CR. Increased Patient Satisfaction After Total Knee Replacement Using Sensor-Guided Technology. Bone Joint J Oct;96-B(10): Gustke KA, Golladay GJ, Roche M, Elson L, Anderson C. Primary TKA patients with Quantifiably Balanced Soft-Tissue Achieve Significant Clinical Gains Sooner than Unbalanced Patients. Adv Orthop. 2014: Bozic K, Kurtz S, Lau E, et al. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res : Rodriguez-Merchan, EC. Instability Following Total Knee Arthroplasty. HSS J. Oct 2011; 7(3): Roche M, Elson L, Anderson C. Dynamic Soft-Tissue Balancing in TKA. Orthopedic Clinics of North America Apr;45(2): Gustke K. Soft Tissue and Alignment Correction: The Use of Smart Trials. Bone Joint J Nov;96-B(11 Supple A): Roche MW, Elson LC, Anderson CR. A Novel Technique Using Sensor-Based Technology To Evaluate Tibial Tray Rotation. Orthopedics Mar 1;38(3). 8. Lombardi AV Jr1, Berend KR1, Adams JB1. Why knee replacements fail in 2013: patient, surgeon, or implant? Bone Joint J Nov;96-B(11 Supple A): Parrate S, Pagnano MW. Instability after total knee arthroplasty. J Bone Joint Surg Am 2008; 90: Tel ORTHO ( ) Fax OrthoSensor, Inc Griffin Road, Suite A-310 Dania Beach, FL USA OS-VS Rev 2