Summary of InFUSE ™ Bone Graft Preclinical and Pilot Clinical Studies with Interbody Spinal Fusion Devices Scott Boden, M.D. Professor of Orthopaedic Surgery.

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Presentation transcript:

Summary of InFUSE ™ Bone Graft Preclinical and Pilot Clinical Studies with Interbody Spinal Fusion Devices Scott Boden, M.D. Professor of Orthopaedic Surgery Director, The Emory Spine Center Emory University School of Medicine

rhBMP-2/ACS vs Autograft Model: Single level interbody fusion with titanium cage in sheep model Duration: Six months Study Groups: (n) Cage & autograft 8 Cage & rhBMP-2/ACS 6 Sandhu, Dawson et al., Spine, In Press 2002

rhBMP-2/ACS vs Autograft

Autograft Control rhBMP-2/ACS

Biomechanical Test Results rhBMP-2/ACS = Autograft

rhBMP-2/ACS vs Autograft Model: Single level interbody fusion with titanium cage in goat model Duration: Six months Study Groups: (n) Cage & autograft 21 Cage & rhBMP-2/ACS 21 Zdeblick et al., Spine, 1998

rhBMP-2/ACS vs Autograft

Biomechanical Test Results No statistical difference in stiffness between autograft and rhBMP-2 fusionsNo statistical difference in stiffness between autograft and rhBMP-2 fusions rhBMP-2/ACS = AutograftrhBMP-2/ACS = Autograft

Rabbit Posterolateral Fusion Model Autograft 42% fusion rhBMP-2/ACS 100% fusion Schimandle, Boden, et. al., Spine 1995

Strength of Bone Generated with rhBMP-2/ACS vs Autograft Relative to adjacent unfused level Schimandle, Boden, et. al., Spine 1995

rhBMP-2/ACS vs Autograft in Non-Human Primates Model: Rhesus monkey, single level interbody fusion Duration: Six months Study Groups: (n) Allograft bone dowel + autograft 3 Allograft bone dowel + rhBMP-2/ACS 3 Fishgrund, Herkowitz et al., Spine,1999 Fishgrund, Herkowitz et al., Spine,1999

Preclinical Study Results (3 months) Fishgrund, Herkowitz et al., Spine, 1999 rhBMP-2/ACS Control

Control(50%) Preclinical Study Results (6 Months) Preclinical Study Results (6 Months) rhBMP-2/ACS(100%) Fishgrund, Herkowitz et al., Spine,1999

rhBMP-2/ACS in Non-Human Primates Model: Rhesus monkey, single level interbody fusion interbody fusion Duration: Six months Study Groups: (n) Cage + buffer/ACS 2 Cage mg/mL rhBMP-2/ACS 2 Cage mg/mL rhBMP-2/ACS3 Boden, Sandhu et al., J. Spine Disorders, 1998

6 Month Fusion Results (%) Control (0%) (0%) 0.75 mg/mL rhBMP-2/ACS (100%) (100%) 1.50 mg/mL rhBMP-2/ACS (100%) Boden, Sandhu et al., J. Spine Disorders, 1998

Collagen Sponge only (6 months) Collagen Sponge + rhBMP-2 (6 months) Boden, Sandhu, et al., J. Spinal Disorders 1998

Collagen Sponge + rhBMP-2 (6 months) Boden, Sandhu, et al., J. Spinal Disorders 1998

InFUSE™ Bone Graft/LT-CAGE™ Pilot Clinical Study Design 4 Investigators Study Groups: (n) LT-CAGE & InFUSE™ Bone Graft 11 LT-CAGE & Autograft 3 Boden, Zdeblick, Sandhu, and Heim, Spine, 2000

InFUSE™ Bone Graft/ LT-CAGE™ Device Human Pilot Study Results Fusion rate InFUSE™ Bone Graft 11/11 (100%) Autograft 2/3 (66%) Boden, Zdeblick, Sandhu, and Heim, Spine, 2000

InFUSE™ Bone Graft/LT-CAGE™ Device Pilot Study - Oswestry Results Boden, Zdeblick, Sandhu, and Heim, Spine, 2000

Serial CT Review-Autograft Patient RightCageLeftCageCoronalView

RightCageLeftCageCoronalView

Serial CT Review-InFUSE ™ Bone Graft Patient RightCageLeftCageCoronalView

RightCageLeftCageCoronalView

Goals of rhBMP-2/ACS Device Safety - no bone formation away from the cagesSafety - no bone formation away from the cages EffectivenessEffectiveness –eliminate bone grafting morbidity –equal or better healing success Goal of rhBMP-2/ACS is to make bone!Goal of rhBMP-2/ACS is to make bone!

Conclusions - rhBMP-2/ACS has success >95% in 4 preclinical studies, substantially better than control ( 95% in 4 preclinical studies, substantially better than control (<50%) Bone formed is normal and biomechanically equal to autograftBone formed is normal and biomechanically equal to autograft CT scan analysis correlates well with histology of rhBMP-2 bone formationCT scan analysis correlates well with histology of rhBMP-2 bone formation The concentration of rhBMP-2 successful in rhesus monkeys produced same 100% success in human pilot clinical trialThe concentration of rhBMP-2 successful in rhesus monkeys produced same 100% success in human pilot clinical trial