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Published bySabina Wells Modified over 9 years ago
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Clinical Review Barbara Buch, M.D. Orthopaedic Surgeon FDA Orthopaedic Devices Branch
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Clinical Review Clinical Summary Highlights of Effectiveness and Safety Radiographic Interpretation: Summary of Additional information Radiographic Interpretation: Considerations for Panel Discussion
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Clinical Summary prospective randomized multi-center concurrently controlled independent radiologists Bayesian statistical analysis high patient & data accountability meticulous adverse event reporting
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Clinical Review
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Clinical Endpoints primary fusion Oswestry pain & disability neurologic status adverse events 2nd surgeries secondary disc height General Health Status back & leg pain patient satisfaction patient global perceived effect antibody testing donor site pain
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Accountability at 24 months Randomized Patients patient 87 - 91% data –primary endpoints 90-95% –secondary endpoints > 89% antibody testing > 91% all groups
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Results Equivalent Findings demographics co-morbidity pre-op medical conditions diagnostic factors levels treated use of post-op bracing pre-op evaluations
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Results Intraoperative Investigational group less EBL less overall OR time Laparoscopic shorter hospital stay equal OR time to open group
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Results Antibody Testing Investigational rhBMP-2 antibodies –1 patient positive = overall failure Antibovine type I collagen antibodies –18 positives –15 overall success Human Type I collagen –no positives Control rhBMP-2 antibodies –1 patient positive = overall success Antibovine type I collagen antibodies –16 positives –10 overall success Human Type I collagen –no positives
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Results Antibody Testing Laparoscopic rhBMP-2 antibodies –1 patient positive = overall failure antibovine type I collagen antibodies –32 positives –17 overall success human Type I collagen –no positives
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Results Antibody Testing No correlation of antibody results with overall or individual success or failure No correlation of antibody results with the occurrence of adverse events
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Results Other Effectiveness Endpoints for both groups: return to work ~ 64 days laparoscopic patients returned 20 days faster
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Conclusions Primary Effectiveness Endpoints
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Conclusions Secondary Effectiveness Endpoints
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Results Adverse Events one death - control patient w/CAD incidence of any adverse event in both groups = 70-80% 8 events related to donor site 6 pregnancies, 2 Miscarriages
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Results Adverse Event Rates
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Results Adverse Events Retrograde ejaculation higher investigational and laparoscopic urogenital No immune-related adverse events 2 cases of cancer- pancreatic, breast no osteogenic cancer
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Results Adverse Events
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Device Related Events No bent, broken devices Investigational > control migration of devices malpositioned devices Control > Investigational loosening/displacement subsidence Investigational = Control cysts found inferior to implant
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Device Related Events Laparoscopic approach associated with higher incidence device malposition anatomic difficulties retrograde ejaculation
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Results Second Surgeries
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Clinical Conclusions equivalent clinical effectiveness equivalent safety similar second surgery rates similar adverse event rates avoids donor site morbidity
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Radiographic Interpretation
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X-rays thin slice CT and reconstructions
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Radiographic Interpretation Xrays and CT scan Comparisons Clinical Trial Animal Autograft BMP Human Autograft BMP
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Radiographic success Fusion plain films: A/P, lateral, flex/ext CT scans: 1mm slices w/1mm index –evidence of bridging trabeculae –no lucency around > 50% of either cage –no motion < 3 mm translation on lateral F/E < 5 o angular motion on lateral F/E
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Radiographic interpretation Xray vs. CT scan
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6 month CT Success
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12 Month CT Success
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24 Month CT Success
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6 Month CT Failure
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12 Month CT Failure
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24 Month CT Failure
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Radiographic interpretation X-ray vs. CT scan Conclusions from comparative studies: AUTOGRAFT X-rays and CT compared to surgical exploration, manipulation, histology: Animal and Human CT scans (reconstructions) correlated with manipulation, histology CT scans higher sensitivity and specificity
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Radiographic interpretation X-ray vs. CT scan Conclusions from comparative studies: rhBMP-2 X-rays and CT compared to surgical exploration, manipulation, histology: animal studies CT scans (reconstructions) correlated with manipulation, histology Appearance (density), and rate of progression differ from autograft and allograft
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Radiographic Interpretation Xrays vs. CT scans Considerations: High fusion rates using both Xray and CT in human clinical trial Xray/CT validation based on Autograft may not be able to extrapolate animal data to potential human responses rate and extent of radiographic changes between auto graft and rhBMP/ACS differ
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Radiographic Interpretation Issues to consider Presence and absorption rate of the collagen sponge identification of the progression of the bone repair process in the presence of rhBMP-2 ability of bone formed at various time points to accommodate applied loads implications on the interpretation of radiographic fusion and physician training
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