Relieving Arthritis Knee Pain Treatment Options
Transcription
Relieving Arthritis Knee Pain Treatment Options
UNDERSTANDING YOUR KNEE Healthy Knee Anatomy Relieving Arthritis Knee Pain Your knee joint is formed by the intersection of the femur (thigh bone), the tibia (shin bone), and the patella (the knee cap). These bones form three “compartments” or sections. 1.Medial compartment (inner half of your knee) •Lateral compartment (outer half of your knee •Patella femoral compartment (behind the knee cap) Michael P. Wertz, MD In a normal functioning knee, each bone glides smoothly against the other on a layer of cartilage that covers the ends of the bone. In a knee joint affected by osteoarthritis, the smooth cartilage lining on the inside of the joint has worn away. Your surgeon can determine the extent and severity of your OA. 4820 Riverbend Rd, Boulder 303-848-2460 Left Knee: Osteoarthritis can affect one, two or all three compartments of the knee. Osteoarthritis: the Disease Osteoarthritis (OA) is the most common form of arthritis, affecting tens of millions of people worldwide. It is a degenerative joint disease characterized by the breakdown and eventual loss of joint cartilage. The breakdown and wearing away of cartilage causes the bones to rub together resulting in extreme pain. OA resulting from “wear and tear” is the most common reason individuals need to undergo knee replacement surgery. UNDERSTANDING YOUR KNEE Treatment Options • Medical Management • Knee Injections • Surgical Options • Joint Replacement Medical Management • Health and behavior modification – Weight loss to help decrease stress on the joints – Exercise to help improve mobility TREATMENT OPTIONS Knee Injections • Corticosteroid (anti-inflammatory) injections for temporary pain relief • Hyaluronic acid injections (viscosupplementation – “WD 40”) – Approved for 6 Month Relief • Physical therapy – Single injection or Multiple injection series – PRP Platelet Rich Plasma • Glucosamine and Chondroitin. Do they really work? Arthroscopy. 2013 Dec;29(12):2037-48. doi: 10.1016/j.arthro.2013.09.006. • Tylenol / NSAIDs for pain management • Braces, canes and other assistive devices The efficacy of platelet-rich plasma in the treatment of symptomatic knee osteoarthritis: a systematic review with quantitative synthesis. Khoshbin A1, Leroux T, Wasserstein D, Marks P, Theodoropoulos J, platelets contain alpha granules that are rich in several growth factors, such as platelet-derived growth factor, transforming growth factor-β, insulin-like growth factor, vascular endothelial growth factor and epidermal growth factor. Stem Cells Microfracture, Scaffolds and Patches Injected Cartiform -What are they doing? -attachment -differentiation Scapholds -can control placement -can modulate differentiation TREATMENT OPTIONS TREATMENT OPTIONS Surgical Options Artificial Meniscus Polycarbonate Disk in early trials Arthroscopic Procedures •Meniscus removal / repair •artificial meniscus •Debridement Joint Realignment •HTO •Interpositional Device Carticel Joint Replacement: Partial Knee Replacement Unicompartmental Knee Arthroplasty Harvested cartilage cells (from previous arthroscopy) are expanded in cell cultures Cells are reimplanted under periosteal membrane harvested from tibia TREATMENT OPTIONS Unicompartmental Knee Replacement iUni® G2 PARTIAL KNEE IMPLANT OPTIONS The only patient-specific unicompartmental knee replacement Joint Replacement: Partial Knee Replacement TREATMENT OPTIONS Bicompartmental Knee Replacement • Designed to treat medial or lateral tibiofemoral osteoarthritis • Provides a customized fit specific to your knee • Designed to mimic the natural shape of your knee to help retain more of your natural function • Allows for a less traumatic procedure and fewer bone cuts to preserve more of your natural knee for future treatment, if necessary Bicompartmental Knee Replacement iDuo® G2 A revolutionary alternative to traditional off-the-shelf TKR • Designed to treat medial or lateral tibiofemoral with patellofemoral osteoarthritis • Combines proven TKR principles for patellofemoral treatment with the advantages of the ConforMIS partial knee system • Treats just the affected knee compartments with a precise, patient-specific implant that delivers unparalleled fit, preserves all ligaments and conserves far more bone than traditional TKR PARTIAL KNEE IMPLANT OPTIONS Joint Replacement: Total Knee Replacement Tricompartmental Knee Replacement TREATMENT OPTIONS Patients Have Reported Dissatisfaction with Traditional TKR PATIENT-SPECIFIC KNEE IMPLANTS Leading Causes of Dissatisfaction 1 in 5 patients are not satisfied with the results of their total knee replacement.1 Residual Pain due to improper fit and rotation Patient-specific implants are intended to address some of the leading causes of patient dissatisfaction. Early Implant Failure due to poor alignment and polyethylene wear PATIENT-SPECIFIC KNEE IMPLANTS Functional Limitations due to altered kinematics and instability Off-the-Shelf knee implants can have painful overhang or underhang because they are not sized to fit each patient. PATIENT-SPECIFIC KNEE IMPLANTS Individualized Implant Fit Patient specific implants fit precisely by using CT scan data to design an implant made for each patient’s own knee. •Patient-specific design that virtually eliminates overhang •Customized fit for every patient Off-the-Shelf TKR iTotal G2 Patient-Specific Implant iTotal® G2 Design Rationale One patient. One implant. © COPYRIGHT 2013 ConforMIS, Inc. MK-02661-AG-10/13 iTotal® G2 Total Knee Replacement System Why iTotal? PATIENT-SPECIFIC KNEE IMPLANTS Understanding Principle Drivers of Dissatisfaction Designed to address some of the leading causes of patient dissatisfaction Early Implant Failure • Leg alignment • Poly wear • Implant engineering • Designed for each individual based on your anatomy • Customized fit and alignment avoids sizing compromises common with traditional offthe-shelf implants Compromised Function Residual Pain • Component fit • Internal rotation of the femur/tibia • Limited range of motion & stiffness • Knee instability • Proprioception 10-15% of TKA patients have clinically significant residual pain1,2 Dissatisfied patients report that their knee does not feel normal at more than 2x the rate of satisfied patients3 • Designed to follow the shape and contour of each patient’s knee to help restore natural kinematics Early failures only 12%, but significant when they occur • Designed for optimal bone preservation • Cost is similar to standard total knee and covered by many major insurance companies 1 Brander VA et al. Predicting total knee replacement pain: A prospective, observational study. Clin Orthop Relat Res. 2003;416:27-36. 2 Katz JN et al. Association Between Severe Pain in the Early Months Following Total Knee Replacement and Functional Outcomes Over Five-Year FollowUp. World Congress of OA. Abstract 80. COPYRIGHT 2013 ConforMIS, Inc. 3 Noble PC et al. Patient expectations affect satisfaction with © MK-02661-AG-10/13 total knee arthroplasty. Clin Orthop Relat Res. 2006;452:35-43. 2222 iAlignTM Alignment Approach for Jigs & Implants iTotal Design Rationale Designed to Neutral Mechanical Axis • Virtual alignment to mechanical axis using anatomic landmarks •Mechanical Axis Alignment Virtual Alignment to Mechanical Axis in Coronal Plane Hip ØCenter of Hip •Patient-Specific Fit & Positioning ØCenter of Femur ØCenter of Tibia •Restoration of Articulating Geometry ØCenter of Ankle •Bone Preservation Knee • Tibial Rotational Alignment ØCT used to set to the anatomic tibial axis •Wear Optimized Design Ankle •Efficient Delivery Model © COPYRIGHT 2013 ConforMIS, Inc. 2323 © COPYRIGHT 2013 ConforMIS, Inc. 2424 iKneeTM Personalized Position, Shape & Fit Personalized Position, Shape & Fit Patient matched, anatomic femur to avoid sizing compromises Symmetric total knee designs force compromises between complete coverage and overhang. Variations in anatomy make it virtually impossible to fit in all areas of the femur. An iTotal femoral component has an image based, patient specific design that follows the anatomy iTotal vs. Standard TKA Example The personalized fit helps take surgeons out of the sizing compromises typical in traditional TKA © COPYRIGHT 2013 ConforMIS, Inc. © COPYRIGHT 2013 ConforMIS, Inc. 2526 Traditional Knee Replacement Traditional Knee Replacement The Challenge of Component Rotation The Challenge of Tibial Rotation vs. Coverage 2628 Off-the-shelf tibial components force a compromise between maximal tibial coverage and proper rotational alignment. When optimized for coverage1: Implants were internally rotated an average of 8.8° Only 30% were aligned within ±5° of proper rotation Maximal Coverage, Improper Rotation J Bone Joint Surg BR. 2010;92-B:1238-44 © COPYRIGHT 2013 ConforMIS, Inc. 2729 1Martin Off-the-Shelf Designs Proper Rotation, Downsized to Prevent Overhang S, Noble P. et al. Optimizing Tibial Coverage is Detrimental to Proper Rotational Alignment. AAHKS 2012: Poster #22 2831 Personalized Position, Shape & Fit ENGINEERING THE CUSTOM TIBIA Designed for proper rotation and fit to avoid known causes of pain Patient-Specific Shape & Fit Rotational Alignment Center of baseplate set to the center of the medial and lateral condyles, shown to be a reliable method of tibial component rotation1,2 1 2 3 Implant profile is then matched to cortical rim, with slight relief to allow +/- 5º intra-operative adjustment without implant overhang, a potential source of pain.3 Cobb JP; The Anatomical Tibial Axis – Reliable Rotational Orientation in Knee Replacement; J Bone Joint Surg [Br]; 2008;90-B:1032-8. Lützner et al.: Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskeletal Disorders, 2010 11:57. Chau R, et. al.,; Tibial component overhang following unicompartmental knee replacement - does it matter?; Knee; 2009; V16:pp. 310-313. © COPYRIGHT 2013 ConforMIS, Inc. 2932 3033 Respect Patient’s Condylar Geometry Respect Patient’s Condylar Geometry iShapeTM Condylar Offset and Joint Line Sagittal ‘J’ Curves Studies have also shown that standard TKR geometry, including single radius designs, alter knee kinematics.1 With iTotal, the patient’s anatomic ‘J’ curves, corrected for deformity, provide the basis for the implant design. Approximating a patient’s medial and lateral ‘J’ curves naturally retains their condylar offset. Studies have shown that this offset occurs at comparable levels, and with comparable ranges, across both OA and non-OA populations.1 Distal Offset Patient’s natural articulating geometry extracted from 3D femoral anatomy Curves are corrected for deformity and then used as the basis for femoral implant design Posterior Offset 1 Hunter 1 Bull DJ, Niu J, Felson DT, et al. Knee alignment does not predict incident osteoarthritis: the Framingham osteoarthritis study. Arthritis Rheum. 2007;56(4):1212-8. AM, Kessler O, Alam M, et al. Changes in kinematics reflect the articular geometry after arthroplasty. Clin Orthop Relat Res. 2008;466(10):2491-9. © COPYRIGHT 2013 ConforMIS, Inc. 3134 © COPYRIGHT 2013 ConforMIS, Inc. 3235 Respect Patient’s Condylar Geometry Respect Patient’s M/L Joint Line Restores Normal Kinematics Restores Normal Kinematics Studies have shown that the natural Flexion-Extension Axis (FEA) and the Transepicondylar Axis (TEA) are not the same and differ an average of 4.6 degrees1 iTotal respects each patient’s native condylar geometry, allowing the knee to rotate about its natural axis M/L joint line angle variability is high, 3.9⁰ +/- 4.0⁰ varus.1 Joint line movement has been shown to alter kinematics and lead to mid-flexion instability2. Rotation required Rotation typically not required M/L Joint Line Angle TEA TEA FEA Joint Line Preserved Joint line altered FEA Off-the-Shelf TKR iTotal 1Poilvache 1 Eckhoff 2 D et al. Difference Between the Epicondylar and Cylindrical Axis of the Knee. Clin Orthop Relat Res. 2007; Aug(461) 238-244. © COPYRIGHT 2013 ConforMIS, Inc. et al. Rotational Landmarks and Sizing of the Distal Femur in Total Knee Arthroplasty. Clin Orthop Relat Res 1996, 331, pp 35-46. Martin J, Whiteside L. The Influence of Joint Line Position on Knee Stability After Condylar Knee Arthroplasty. Clin Orthop Relat Res 1990, 259, pp 146-156. © COPYRIGHT 2013 ConforMIS, Inc. 3336 Dual BalancingTM technology facilitates proper balancing of offset 6 Cut Design to Maximize Bone Preservation femur and joint line Comparison to standard total knee systems Femur Matched Offset Polys Separate medial and lateral poly inserts matched to femoral offset 3 lateral thicknesses (medial+offset) Medium Size Femoral Implant Thickness 3 medial insert options (6, 7, and 8mm) (Measurements A-P Size Length in mm) Offset helps mimic varus angle of normal tibial plateau Medial insert more conforming than lateral insert to facilitate rollback 28% volumetric bone preservation advantage for iTotal X-rays show two legs with different offsets, but both aligned to neutral mechanical axis *sample size is average of 5 representative designs matched for AP length. ConforMIS data on file. © COPYRIGHT 2013 ConforMIS, Inc. 3437 3538 Distal Medial Distal Posterior Posterior Lateral Medial Lateral ZMH NexGen E 62 9 9 9.3 9.3 J&J PFC Sigma 3 61 9 9 8 8 SNN Legion 5 62 9.5 9.5 9.3 9.3 SYK Triathlon PS 4 62 8.5 8.5 8.5 8.5 SNN Journey 5 62 9.5 7.0 9.5 7.4 - 61.8 9.1 8.6 8.9 8.5 6.9 6.8 5.8 5.8 -2.2 -1.8 -3.1 -2.7 Average for Sample Average for ConforMIS 62.0 Sample* Delta (Standard vs. ConforMIS) © COPYRIGHT 2013 ConforMIS, Inc. 3639 Traditional “Delivery Model” Engineered Design Features Extensive System Instrumentation in OR Wear optimization and engineered function High conformity dome Patello-Femoral joint 8-12 trays of specialized instrumentation required for a joint replacement procedure Extended trochlear groove to guide patella in deep flexion Lowered lateral trochlea to decompress soft tissue Knee Example Wide coronal geometry for high conformity to poly with low constraint © COPYRIGHT 2013 ConforMIS, Inc. Intercondylar notch width driven by patient anatomy rather than need to accommodate upsizing and downsizing 3740 All instrument trays opened require set up, break down and sterilization Hip Example COMPANY CONFIDENTIAL – INTERNAL USE ONLY © COPYRIGHT 2013 ConforMIS, Inc. Traditional “Delivery Model” ConforMIS “Delivery Model” Extensive Hospital Inventory Management A Model for a More Efficient Joint Replacement System 3842 Patient imaging study at validated center 3D Image processing Extensive implant inventory storage & management by OR operations staff COMPANY CONFIDENTIAL – INTERNAL USE ONLY Implant & instrument delivery to the OR after sterilization and prep by central supply © COPYRIGHT 2013 ConforMIS, Inc. 3943 Implant &® iJig® Implant & iJig design design & & manufacture manufacture One package delivered for Surgery 6 Week Delivery Time Implant Request Form (IRF) submitted COMPANY CONFIDENTIAL – INTERNAL USE ONLY © COPYRIGHT 2013 ConforMIS, Inc. 4044 ConforMIS “Delivery Model” iFit® Image-to-Implant™ Technology Efficient, Pre-Sterilized, Disposable Single use kit delivered a few days before surgery CONFORMIS PATIENT-SPECIFIC TECHNOLOGIES Advances in Imaging One reusable instrument tray iTotal G2 instrument set and implants provided for use in the OR COMPANY CONFIDENTIAL – INTERNAL USE ONLY © COPYRIGHT 2013 ConforMIS, Inc. Joint Replacement iFit video 4145 TREATMENT OPTIONS iTotal – True Patient Specific Fit and Shape What to Expect After Surgery A typical patient should expect: •You will be out of the hospital within 2 days and then begin your rehabilitation •You should be able to weight bear soon after surgery, and walking with an aid at discharge •Long-term results of knee surgery depend on your work in rehabilitation •By 6 weeks, you should be able to engage in many of your typical daily activities •More physical activities, such as sports may take 3 months to be able to do comfortably © COPYRIGHT 2013 ConforMIS, Inc. 4450