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InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065

InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065. Hallett H. Mathews, M.D. Richmond, Virginia. Important Findings. Primary study objective met High fusion rates Shorter operative times and less blood loss

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InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065

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  1. InFUSE™ Bone Graft /LT-CAGE ™ Lumbar Tapered Fusion DeviceIDE Clinical ResultsG960065 Hallett H. Mathews, M.D.Richmond, Virginia

  2. Important Findings • Primary study objective met • High fusion rates • Shorter operative times and less blood loss • Avoided complications and pain associated with bone graft harvesting

  3. InFUSE™Bone Graft versus Autograft Harvested from Iliac Crest

  4. Clinical Trial Results

  5. Clinical Trial DesignOpen Surgical Approach • Prospective, randomized controlled design • Investigational Treatment - LT-CAGE™ Device / InFUSE™ Bone Graft • Control Treatment - LT-CAGE ™ Device / autogenous bone

  6. Study Objectives • Primary Objective Equivalence in Overall Success • Secondary Objectives

  7. Study Entrance Criteria • Single level • Symptomatic degenerative disc disease • Inclusion/exclusion criteria

  8. Patient Evaluation • Preoperatively • Surgery/Discharge • Postoperatively: 6 Weeks, 3 Months, 6 Months 12 Months, 24 Months

  9. Patient Population • Patients - 143 received InFUSE™ Bone Graft - 136 received autogenous bone graft • 16 Investigational Centers

  10. Demographic Information

  11. Surgery Data

  12. Study Results Based on 24-Month Data

  13. Overall Success • Fusion •  15 point improvement in Oswestry score • Neurological maintenance or improvement • No serious adverse event possibly associated to the device • No second surgery failure

  14. Overall Success Rates

  15. Achieved Primary Objective

  16. Safety Overview • Adverse events • Second surgery procedures • Antibody formation

  17. Adverse Events

  18. Adverse Events

  19. Comparison of Adverse Eventsin Investigational and ControlTreatment Groups

  20. Differences noted in: • Graft Site Events - Occurred in 6% of control group None in investigational group • Urogenital Resolved prior to discharge

  21. Adverse Events • Typical for patient population • Not unanticipated

  22. Second Surgery Procedures

  23. Classifications • Revisions • Removals • Supplemental Fixations • Reoperations • Other

  24. Classifications • Revisions - Failure • Removals - Failure • Supplemental Fixations - Failure • Reoperations • Other

  25. Second Surgeries

  26. Assessment of Antibody Formation • rhBMP-2 • Bovine Type I Collagen • Human Type I Collagen

  27. Comparision ofAuthentic Positive ResponsesSimilar for both groups • One patient in each group had positive response to rhBMP-2. (<1%) • 13% in each group had positive response to bovine Type I collagen. None of these patients had positive results for human Type I collagen.

  28. Safety Summary Investigational and Control group rates are similar for: • Adverse events and second surgery procedures • Antibody responses InFUSE™ Bone Graft eliminates graft harvesting adverse events and pain

  29. InFUSE™ Bone Graft / LT-CAGE™ Device Safe for its intended use

  30. Effectiveness OverviewInFUSE™ Bone Graft / LT-CAGE™ Device patients had: • High fusion rates • Pain relief • Maintenance or improvement in neurological status

  31. Fusion • Primary endpoint • CT scans and radiographs utilized • Two teams of independent reviewers

  32. Fusion Criteria • Radiographic - Bridging trabecular bone - Segmental stability - Lucent line criteria • No “pseudarthrosis” second surgery

  33. Fusion Success Rates

  34. Oswestry Low Back PainDisability Questionnaire

  35. Mean Oswestry Scores

  36. Oswestry Success 15 Point Improvement

  37. Neurological Status Measurements • Motor Function • Sensory • Reflexes • Straight Leg Raise

  38. Neurological Success Rates

  39. Secondary Effectiveness Endpoints • Back pain • Leg pain • Disc height maintenance • SF-36

  40. Back Pain Results - 24 Months

  41. Graft Site Pain in Control PatientsMean Scores

  42. Graft Site Appearance in Control Patients

  43. Use of InFUSE™Bone Graft eliminates: Negatives of Graft-site Appearance, Pain and Morbidity

  44. Laparoscopic Clinical Trial • Data augment safety profile • Supports approval of implantation method • Identical protocol to open study • 134 Investigational patients • 14 Sites

  45. Surgery Data - Laparoscopic • 2 days shorter hospital stay • 45% treated on outpatient basis • Returned to work 20 days sooner

  46. Overall Success Rates - Laparoscopic Study

  47. Safety Results - Comparable to Open Surgical Treatment Group

  48. Laparoscopic Versus Control 24 Months

  49. Fusion Success Rates - Laparoscopic Study

  50. Case Histories

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