The KineSpring Knee Implant System Product Information

Transcription

1 The KineSpring Knee Implant System Product Information

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3 The Treatment Gap Increasing numbers of young, active OA patients with longer life expectancy and higher activity demands. 1 Large increase in arthroplasty procedures in patients <55 years old as surgeons attempt to fill the treatment gap with existing therapies. 1 Higher revision rates and poorer outcomes in younger, active patients, especially with Unicompartmental Knee Arthroplasty (UKA) (Fig. 1). 2, 3! For early osteoarthritis patients who hope to delay or avoid joint-altering surgery. Fig. 1: Higher revision rate in UKA patients <55 years. Nordic Orthopedic Federation Underlying Load Reduction Principles Unloading therapies reducing the external Knee Adduction Moment (KAM) by 5 19% have been proven to result in pain relief KineSpring System Load Reduction Profile 13 30%! 13 kg of unloading reduces KAM by a pain relieving, therapeutic amount. 25% Reduction in KAM (%) 20% 15% 10% 5% Therapeutic Range KAM GRF KAM = GRF x LA 0% Body Weight (kg) Fig. 2: Between approx kg the unloading provided by the KineSpring System is within the therapeutic range. LA The higher the external KAM, the greater the internal compressive loading on the medial aspect of the knee.

4 Absorber Cobalt Chrome. One size. Pre-compressed to 13 kg. Attached to bases intraoperatively.! Reduces load on medial knee compartment by up to 13 kg during stance phase of gait. Ball & Socket Design 50 varus-valgus. 155 flexion-extension. >60 internal-external rotation. Cobalt Chrome articulation.! Maintains patient s natural kinematics Femoral Base Titanium alloy. Three contours (40, 45, 50 indicate tilt of socket to bone surface) to accommodate metha physeal flare. Fixed with one compression screw and three locking screws. 14 mm 45 Tibial Base Titanium alloy. One shape. 14 mm offset of socket center to bone surface required for soft tissue clearance. Fixed with one compression screw and three locking screws.! 3 mm feet allow for minimum contact between bases and soft tissue or bone 3 mm

5 KineSpring System Unloading Partial joint unloading, through compression of the KineSpring absorber, during the gait phase between flexion angles of 0 30 (>30 of flexion, the absorber relaxes and becomes passive). The absorber does not exert joint distraction. Unlike HTO or fracture plate components, the KineSpring Implant System will not bear full joint load; only a maximum of 13 kg, the amount unloaded by the KineSpring absorber % Supported Knee Absorber Flexion Angle ( ) >30 Unloading 13 kg >0 kg 0 kg (maximum)! Significant medial knee compartment unloading during the stance phase of gait (0 60% of gait cycle) without transferring load to the lateral compartment. Medial Compartment* 100 KineSpring System Active & Unloading KineSpring System Passive Untreated 40 KineSpring System Normalized Compartment Force 20 0 Lateral Compartment* Stance Swing KineSpring System 40 Untreated Stance Swing Percent Gait * Load reduction data based on testing of a dual spring, 18 kg load absorption design.

6 Case Reports Successful joint unloading resulting in immediate symptom relief and improved knee function Case A: 12, * Clinical information Age: 52 Gender: Female BMI: 30.9 Pre-treatment Diagnosis: K-L grade 2 Operative Side: Left knee Score/time Pre-treatment 3 years post treatment % improvement WOMAC Pain % WOMAC Function % WOMAC Stiffness % Results At 3-year visit all patient-reported outcomes were significantly improved compared to baseline. Courtesy of Dr. David A. Hayes, Australia. Case B: 13, * Clinical information Age: 63 Gender: Male BMI: 31 Pre-treatment Diagnosis: K-L grade 3 Operative Side: Left knee Score/time Pre-treatment 1 year post treatment % improvement WOMAC Pain % WOMAC Function % WOMAC Stiffness % Results At 1-year visit, all patient-reported outcomes were improved compared to baseline. Courtesy of Mr. Nicholas J. London, United Kingdom. * Case A depicts different generation implant than case B.

7 Key Points Significantly reduces Osteoarthritis pain 13 Significantly improves function 13 Protects the diseased knee, while maintaining natural movement Immediate weight bearing possible Allows patients to return to normal activity Straightforward soft tissue sparing surgical technique Does not impede future, more invasive surgical options Safe, reversible procedure Partially unloads weight on knee joint 13,14 Short recovery time

8 References 1. W-Dahl, A. et al. Surgery for knee osteoarthritis in younger patients. Acta Orthop 2010 Apr: 81(2): W-Dahl, A. et al. Unicompartmental knee arthroplasty in patients aged less than 65. Acta Orthop 2010 Feb; 81(1): Pearse, A. et al. Survival and functional outcome after revision unicompartmental to a total knee replacement. J Bone Joint Surg [Br] 2010, 92-B Christensen et al., Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis Apr;66(4): Epub 2007 Jan Messier et al., Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum Jul;52(7): Draganich et al., The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis. J Bone Joint Surg Am Dec;88(12): Lindenfeld et al., Joint loading with valgus bracing in patients with varus gonarthrosis. Clin Orthop Relat Res Nov;(344): Pollo et al., Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med May-Jun;30(3): Self BP, et al., A biomechanical analysis of a medial unloading brace for osteoarthritis in the knee. Arthritis Care Res Aug;13(4): Hunt et al., Associations among knee adduction moment, frontal plane ground reaction force, and lever arm during walking in patients with knee osteoarthritis. J Biomech. 2006;39(12): Epub 2005 Oct Thorp et al., Relationship between pain and medial knee joint loading in mild radiographic knee osteoarthritis. Arthritis Rheum Oct 15;57(7): Hayes DA. et al., Knee Osteoarthritis Treatment with the KineSpring Knee Implant System: A Report of Two Cases. Case Rep Orthop. 2012;2012: doi: /2012/ Epub 2012 Dec Data on File at Moximed 14. Heiney, J et al. Distal Femoral Fixation: A Biomechanical Comparison of Trigen Retrograde Intramedullary (I.M.) Nail, Dynamic Condylar Screw (DCS), and Locking Compression Plate (LCP) Condylar Plate. J Trauma 2009;66: Dedicated to improving the standard of care for patients with Osteoarthritis 2013 Moximed International GmbH Rev A Moximed International, GmbH Technoparkstrasse Zürich, Switzerland Office: Fax: international@moximed.com