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Indirect Decompression and Fusion for Cervical Radiculopathy: DTRAX

Indirect Decompression and Fusion for Cervical Radiculopathy: DTRAX. MKT-PMT-061. Posterior Cervical Fusion Final Frontier for MIS. ??. Technology Has Not Yet Enabled This to be MIS. Facet Screws Have Shown Promise. Technique challenges and risk have limited adoption and lack of fusion.

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Indirect Decompression and Fusion for Cervical Radiculopathy: DTRAX

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  1. Indirect Decompression and Fusion for Cervical Radiculopathy: DTRAX MKT-PMT-061

  2. Posterior Cervical Fusion Final Frontier for MIS ??

  3. Technology Has Not Yet Enabled This to be MIS

  4. Facet Screws Have Shown Promise Technique challenges and risk have limited adoption and lack of fusion

  5. Goals of MIS Posterior Cervical Instrumentation • Less Invasive Approach than Lateral Mass Screw/Rod Constructs • Enable Fusion by Preparing Joint and Delivering Fusion Material • Stabilize Segment

  6. DTRAX: Minimally Disruptive Posterior Cervical Fusion • Minimally Disruptive Instrumentation • Indirect Decompression • Stabilization and Fusion

  7. DTRAX: Minimally Disruptive Instrumentation • Does not remove healthy tissue or stabilizing structures • Burns no bridges to future treatment • Favorable cosmetic outcome

  8. DTRAX: Indirect Decompression • 3 MM Facet Distraction Delivers 20%+ Increase in Foraminal Area Buckley et. al Foramen distraction effectiveness of the DTRAX facet screw system Tan et. al Effect of machined intra-facet allograft on foraminal height and area

  9. DTRAX Implants: Expandable Cage • CE Mark in July 2011 • Available Outside of U.S.

  10. DTRAX Implants: DTRAX Cervical Cage • 510K Clearance May 2013 • First U.S. Case in November 2013 • Available in Bullet Nose and Taper The DTRAX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

  11. DTRAX Implants: DTRAX Graft DTRAX Graft Specifications • DTRAX Graft is a structural cortical allograft implant used to promote spinal fusion. • Bench top testing supports the structural strength of DTRAX Graft. • 25+ lbs. of pullout strength* • 160+ lbs. of compressive strength*

  12. DTRAX: Instrumentation • Single Use Disposable • 1 CM in Outer Diameter 5 2 6 4 7 1. Access Chisel 2. Decortication Device 3. Tuning Fork Mallet 4. Guide Tube 5. Chisel Rasp 6. Implant Delivery Tool 7. Bone Graft Delivery Tool 1 3

  13. What is the Role of MIS Posterior Stabilization? Supplemental stabilization and posterior fusion w/ ACDF Spondolytic radiculopathy and foraminal stenosis Symptomatic non-union from ACDF

  14. DTRAX: Treatment of Cervical Radiculopathy • First 60 Patients Treated

  15. Improvement in Pain Scores at 12 Months

  16. Improvement in Pain Scores at 12 Months

  17. Comparable NDI Outcomes to Accepted Cervical Operations

  18. Minimal Changes to Lordosis • *P < 0.05

  19. Positive Fusion Rates • 93% of Patients Fused Verified by CT

  20. Complications • Two Intraoperative Facet Fractures • Access tool redesigned to address • Two inability to access facet • Unilateral procedure performed • No vertebral artery, nerve root or spinal cord injuries • No implant migration

  21. What is the Role of MIS Posterior Stabilization? Supplemental stabilization and posterior fusion w/ ACDF Spondolytic radiculopathy and foraminal stenosis Symptomatic non-union from ACDF

  22. Treatment of ACDF Non-Union

  23. Is Posterior Fusion the Answer? • 33 Patients treated with Posterior Fusion following failed ACDF • 4 Year Average F/U • 100% Fusion Rate • 48% Continued Pain • - 28% Mod/Severe

  24. What is the Role of MIS Posterior Stabilization? Supplemental stabilization and posterior fusion w/ ACDF Spondolytic radiculopathy and foraminal stenosis Symptomatic non-union from ACDF

  25. Should We Back Up Multi-Level ACDF? • 1 Level ACDF Fusion Rate – 92% • 2 Level ACDF Fusion Rate – 80% • 3 Level ACDF Fusion Rate – 65%

  26. Is There a Role in 2-Levels ACDF? • 20% non-union rate in 2 level ACDF control arm • 12% re-operation rate

  27. Case Studies

  28. Summary • Posterior cervical has not advanced as rapidly as other areas of spine • DTRAX is a minimally-disruptive technology for posterior cervical indirect decompression and fusion • Initial data in treatment of cervical radiculopathy promising • Potential application in treatment of pseudoarthrosis and to supplement multi-level ACDF

  29. Thank You

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