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Orthopedic Coatings: Predictions for 2025

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What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.

Published in: Health & Medicine
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Orthopedic Coatings: Predictions for 2025

  1. 1. Orthopedic Coatings: Predictions for 2025 A Surgeon’s Perspective Gordon D. Donald, M.D. NJ Ortho Group, LLC Molecular Surface Technologies, LLC June 13, 2019
  2. 2. Pin Tract Infections and Bioglass Coated Pins Univ of Vermont, 1979-80 Poor materials Poor manufacturing (by today’s standards) Mismatched materials
  3. 3. Orthopaedic Surgeons’ Motivations • Professional Success/Clinical Effectiveness • Good patient outcomes • Do no harm • Compensation • Procedural reimbursement decreasing across the board • Change • Creatures of habit • Cost
  4. 4. Clinical Effectiveness • Process works and is clinically significant • Process is easy requiring no extra work • Process is transparent to normal workflow
  5. 5. Compensation • Orthopedic surgery is a “piecemeal” business • There are a finite number of surgical cases • Must improve surgeons efficiency and/or allow for more procedures or decreased operative time • Improve surgeon’s quality of life
  6. 6. Change • Orthopedic surgeons hate change • Device changes need to be transparent or imperceptible to the surgeon • Must feel the same and give same proprioceptive feedback • No change in normal workflow or technique • No extra work • No extra time
  7. 7. Cost • The new bane of an orthopedic surgeon’s survival • Multiple stakeholders • Surgeon • Does it take more of my or my staff’s time and effort • Hospital • Is this a pass-through cost or does it effect my bottom line • Insurance Company • Generally considers only immediate cost with little investment in future outcome • Patient • Does this cost more recovery time, out of work time, or can I avoid another operation
  8. 8. 5 Year Spinal Surgeon Wish List • Improved clinical outcomes • Many variables but most dependent on boney healing and decreased complications • MIS • Less invasive and faster healing/return to function • Less space/volume for bone grafting materials • Improved navigation • High cost with no separate reimbursement • Robotics • High cost with no separate reimbursement • Biologics/tissue engineering • Need much more research
  9. 9. Orthopedic Clinical Needs for Coatings • Antimicrobial • Decrease device related deep infections • Bone • Improve bone healing directly to material surface • Others (lubricity, surface protection, drug delivery)
  10. 10. Device Related Deep Infections • Almost all implant infections are related to the inoculation of bacteria on to the device surface at the time of surgical implantation • There is only a small percentage of deep infections that are truly secondary (occur from late bacterial seeding), mostly with immunocompromised patients • Deep implant infections are a surface phenomena
  11. 11. Device Surface • For most current biomaterials used, the material surface is immunodeficient and acts almost as an immunocompromised host • Whereas 1000s of bacteria are required to initiate a non-implant infection, only a few bacteria may result in an implant related infection • For prevention of infections, the primary, and probably only needed antimicrobial effect is that the device surface be • most clinically effective • least systemically toxic (best regulatory strategy)
  12. 12. Antibacterial coating of implants: are we missing something? C. L. Romanò, H. Tsuchiya, I. Morelli, A. G. Battaglia, L. Drago Published Online: 28 May 2019 https://doi.org/10.1302/2046- 3758.85.BJR-2018-0316 • Romano et. al (2019)calculated that the total direct costs savings of decreasing infection rate of TJA implants, with up charge of €600 per implant, would save €440 million per year in Europe. This would be roughly a savings of $1.75 billion in the US marketplace.
  13. 13. Characteristics of an Ideal Antimicrobial Surface • Broad-spectrum antimicrobial effect • Rapid antimicrobial effect • Stable • No change to mechanical characteristics of device • Easy, scalable manufacturing • Relatively low-cost • May be applied to multiple materials • Clear regulatory pathway
  14. 14. Bone: “the more bone the better” • Bone healing • Bone stabilization • Bone fusion • Spinal implants • Interbody • Posterior instrumentation • Joint reconstruction
  15. 15. Treatments to Enhance Bone • Passive • Coatings or surface modifications that allow for biologic activity resulting in local bone growth • Provides for a geometrically friendly surface and osteointegration • May allow surface protein adsorption to promote osteogenic process • Active • Promotes osteogenic process without the need of separate signaling protein adsorption • Osteoblastic response occurs directly with material surface
  16. 16. Passive Bone Enhancement Surfaces • Specific biomaterials • Ti is hydrophilic and considered “bone friendly” • Normal PEEK is very hydrophobic and bone unfriendly • Surface texturing/3-D • Osteoconductive/osteointegration • Fibrous layer between bone and material remains • CaP surfaces • Osteoconductive and requires protein deposition/adsorption • Nano texturing • Requires protein absorption to initiate cellular response • Osteoconductive and probably osteoinductive
  17. 17. Active Bone Enhancement Surface • Molecular surface modification with bioactive signaling peptides, proteins, etc. • Direct attachment of osteoblast to surface • No need for passive protein adsorption and therefore not dependent on host response • Results in not only surface attachment of bone cells but also acceleration and amplification of local bone healing process
  18. 18. 2025: Where Are We Going to Be? • Evolutionary tweaks and changes to the implant systems will continue to dramatically decrease from the past • Advances will be all about better materials and better biology • We like the mechanical properties and function of current implant materials but not very biologically effective • Coatings over the past 20 years have been marginally effective and successful • May perceive a need for new biomaterials that provide optimal mechanical and biologic function, but unlikely over next five years in current regulatory environment • Optimize current material surfaces to provide necessary function without need for additional coatings or layers
  19. 19. Molecular Surface Technologies • Molecular modification of material surface with stable and robust covalently bound functional molecules • Provide potent antimicrobial properties • Provide active bone enhancement • Applicable to multiple materials- metals, polymers, tissue • Defined regulatory path • Proprietary processes for exceptionally cost-effective scalable manufacturing
  20. 20. ORTHOPEDIC IMPLANT COATINGS WHERE HAVE WE BEEN AND WHERE ARE WE GOING? Christopher Scifert, Ph. D Director of Engineering Orchid Design (A Division of Orchid Orthopedic Solutions)
  21. 21. OVERVIEW • Clinical issues with orthopedic implants • Current coating technologies in the market • Market trends • Coatings 2025
  22. 22. CLINICAL ISSUES WITH ORTHOPEDIC IMPLANTS • Infection – Biofilm – Bacterial adhesion • Loosening – Aseptic loosening – Osteolysis – Stress shielding • Wear – Particulate debris migration – UHMWPE particles – small particles, number of particles • Corrosion/Ion Release – Galvanic – Fretting – Surface Oxidation – Metal Allergy
  23. 23. CURRENT COATING TECHNOLOGIES IN THE MARKET • Fixation - Bone Ingrowth/Ongrowth – Sintered coatings (beads/wire) – Plasma Spray Titanium (TPS) – Calcium phosphate – Hydroxyapatite • Wear Reduction/Anti-Allergy/Anti-corrosion – PVD/CVD coatings • Titanium Nitride (also Titanium Niobium Nitride) • Chromium Nitride • Zirconium Nitride • Diamond Like Carbon (DLC) – Surface modifications • Oxinium™ Oxidized Zirconium • Nitrogen Ion Implantation • Anti-microbial – Gentamicin Poly(d, l-lactide) – Silver coating (MUTARS and Agluna) – Povidone-Iodine based coatings
  24. 24. MARKET TRENDS • Component Trends – Cost sensitive – Evidence based – CoCr materials are not price stable – Lower stiffness components for stress shielding – 3D printing • Coating Trends / Needs – Low cost – Damage resistant – Wear resistant coating (enhance tribological properties of the system) – Bioinert – Low propensity to form biofilms
  25. 25. COATINGS 2025 • Ceramic Coatings – Allow lower modulus components as articulating surfaces • Titanium Alloy – Increase wettability (reduce surface tension) – Less sensitivity to brittle failure – Easier regulatory path than monolithic ceramic • Plasma Spray Ceramic Coatings – Used in aerospace and other industries – Durable – FDA indicates coatings like this will not change device classification – Early indicators are that wear performance is significantly improved vs. uncoated CoCr – Thicker than CVD/PVD (50-200 micron vs 5-10 micron) • Variety of materials – Aluminum Oxide/Titanium Oxide – Chrome Oxide – Zirconium Oxide
  26. 26. CONCLUSION • Low cost durable coatings – Wear reduction – Metal allergy control • Articulating surface applications – Ceramic coatings • Plasma spray • CVD/PVD
  27. 27. Thinner. Faster. Stronger. Ulf Brogren, President, Promimic Inc OMTEC 2019
  28. 28. 2 Optimized for Osseointegration The HAnano Surface is a 20 nanometer thin layer of hydroxyapatite (HA) which through size, shape and structure mimics human bone. The super-hydrophilic surface attracts bone cells, accelerates healing and increases anchoring strength. Proven clinically on dental implants to improve implant fixation and faster osseointegration. 1 µm
  29. 29. 3 New Size Regime Traditional coating 40-80 µm 80 µm 0.02 µm
  30. 30. 4 Wet Chemistry Coating Method Online video: http://www.promimic.com/index.php/products/coatingprocess
  31. 31. 5 Introducing Hydrophilicity
  32. 32. 6 Creator of Faster Osseointegration
  33. 33. 7 Titanium Implants in Diabetic Model  Systemic diseases, such as diabetes mellitus (DM), may negatively influence osseointegration  Diabetes is considered a risky condition for dental implants – delayed wound healing – prevalence of microvascular disease – impaired response to infection  The purpose of the study was evaluate the biologic response in diabetic and non-diabetic rats  Acid etched titanium implants were used with 7 and 30 days of healing
  34. 34. 8 Results Microtomographic analysis showed that the implant surface coated with the HAnano Surface presented the best values in all of the evaluated parameters both in 7 and 30 days after implant insertion, and especially in the diabetic rats Scombatti de souza (2016), Microtomographic evaluation of a new nanometric hydroxyapatite covered implant surface. In vivo study in diabetic rats Acid etched titanium implants HAnano Surface coated acid etched titanium implants Improved Integration for Risk Patients
  35. 35. 9 HAnano Surface in Short  Unique surface modification for all implant materials and shapes  Creates a super hydrophilic interface for osseointegration  Verified in +20 in vivo studies and +100.000 patients for dental implants  Regulatory pathway through 510(k)  Cost effective business model and fast track to market through Danco partnership

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