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The Future of Orthobiologics in Trauma Procedures

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Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.

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The Future of Orthobiologics in Trauma Procedures

  1. 1. Future of Orthobiologics in Trauma Procedures Daniel N. Segina, M.D. Orthopaedic Service Line Medical Director Vice Chairman, Department of Orthopaedics Health First, Holmes Regional Trauma Center Melbourne FL
  2. 2. Disclosures Consultant: Stryker Breg 3M Muzihosi Owner / Shareholder: Genesis Medical Devices Breaking Away Consulting
  3. 3. Objectives 1. Understand the spectrum of orthobiologics used in orthopaedic trauma cases 2. Differentiate the facts versus the hype in orthobiologic clinical applications 3. Appreciate the economic impact orthobiologics represent in orthopaedic trauma care
  4. 4. “BIO” Warfare BIO-logyBIO-mechanics
  5. 5. Spectrum of products Allograft (Old school) Cancellous void filler Structural cortical graft Osteochondral graft for defect Tendon DBX Allograft (New School) Placental/Embryonic tissue Autograft Cortical/cancellous bone Tendon PRP BMA/MSC Ceramics/Synthetics Injectable +/- Ca+P/S/OH BMPs
  6. 6. Spectrum of choices
  7. 7. Biologics Basics for Orthopaedic Trauma: Bone Formation Requirements
  8. 8. Biologics: Specifics Osteogenic Material Autograft Allograft? Autologous bone marrow Autologous blood concentrates? Demineralized bone matrix? Amniotic products Osteoconductive material Ceramics/synthetics Autograft Allograft Osteoinductive factors BMPs Autograft
  9. 9. Orthopaedic Trauma and Fracture Care Fill voids – case examples Metaphyseal bone loss Enhance healing – case examples Index injury Nonunion Replace structure – Case examples Structural bone/cartilage loss
  10. 10. Fill Voids
  11. 11. 65-yo female fall in hospital parking lot
  12. 12. Enhance Healing/Replace Bone Loss
  13. 13. 33-yo female retired police officer
  14. 14. 18 month F/U
  15. 15. Replace tissue loss
  16. 16. 34-yo high velocity GSW while wild boar hunting
  17. 17. Good and Bad News Neuro/vasc intact PCL, post capsule, MCL Med Fem Condyle 75% Medial Plateau 50% Lat Fem Condyle LCL, ACL, Patellar Tendon Ant soft tissue + Ant Menisci 50% lateral plateau Maintained Missing
  18. 18. Synthes impl
  19. 19. Fact vs. Hype Clinical data supporting the use of orthobiologics
  20. 20. Fact vs. Hype Clinical data supporting the use of biologics in orthopaedic trauma care
  21. 21. ?
  22. 22. Physician’s Prospective
  23. 23. Levels of Evidence: Evidence Based Practice Level I Prospective randomized trial Level II Prospective cohort study Level III Case-control Study Level IV Uncontrolled case series Level V Expert opinion
  24. 24. FDA vs. Reality Most biologics are classified as devices Most orthopaedists do not think of biologics as devices
  25. 25. Demineralized Bone Matrix: Hype “readily available bone void filler with growth factors” Data No level I or II human data Pico grams of growth factors Major variability in quality
  26. 26. Calcium Salts/Ceramics CaCO3 / Ca3(PO4)2 / Ca5(PO4)3OH / CaSO4 Hype Void filler / Osteoconductive matrix Better than autograft??? Data Level I data “The Gold Standard in Tibial Plateau Fractures? A Prospective Multicenter Randomized Study of AIBG vs. Alpha-BSM” Russell TA et.al.
  27. 27. Allograft Hype Void filler / Osteoconductive matrix Small amounts of growth factors Data Level II and III
  28. 28. Autograft Hype “Gold Standard” Data Assumed “Gold Standard” until proven otherwise 15%-38% combined complication rate
  29. 29. Platelet Concentrates (PRP) Hype “small bags full of growth factors” Data No Level I or II Pico grams!
  30. 30. Bone Marrow Concentrates Hype “Better than the gold standard” Data Minimal level I or II
  31. 31. BMP/growth factors Hype “long awaited Holy Grail of orthopaedics” Data Minimal Level I data Narrow FDA indications
  32. 32. Amniotic Fluid Products Hype Novel allogenic source for stem cells Data Should not be considered stem cell therapies
  33. 33. Amniotic Fluid Products
  34. 34. $8.4B $11.9 B 2016 2020 Biologics represent a large spend for U.S Hospitals The economic impact of orthobiologics in orthopaedic trauma care
  35. 35. Biologics Product Types Market Size
  36. 36. Cost data: Bone Void Fillers (ASPs) DBMs ($125-$175/cc) Allograft cancellous bone ($15-$30/cc) Cellular Allografts ($350-$600/cc) Synthetics – non hardenings ($125-$250/cc) Synthetic – Hardenings ($225-$350/cc) Infuse BMP Large kit $5,300 BMA 60-120cc 1 “spin” $1,500
  37. 37. Cost and utilization data for “routine” tibial nonunion: Recent tibial nonunion repair cost analysis Traditional Implants Tibial nail - $3,000 Interlocking screws (4) - $1,400 Disposables (wires, bits) - $350 $4,750 Biologics BMA - $1,500 30cc allograft chips - $450 BMP large kit - $5,300 $7,250
  38. 38. System Spend For Biologics: ~ 1200 spine procedures, 1400 fractures, 1600 TJA
  39. 39. Default Choices? Void filler ? Biologic Activity?
  40. 40. Void Filler Allograft Demineralized Bone Matrix Calcium Salts
  41. 41. Biologic activity needed Autologus Bone BMC + Allograft
  42. 42. What does the future have in store?
  43. 43. Concern that “misinformation” from marketing of largely unproven biologic treatments may erode the public trust and the responsible investments needed to bring legitimate biologic therapies to patients…minimal standards for product characterization and clinical research should be followed. Translated: We need quality data!
  44. 44. Special Thanks: Mr. Roberto Bracone Director of Biologics Marketing, Stryker Orthopaedics
  45. 45. Thank You

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