A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment

Spine
Masahiro KanayamaDaisuke Togawa

Abstract

A prospective, randomized and controlled study. To evaluate the osteoinductive property of Osteogenic Protein-1 (OP-1 or BMP-7) and fusion rate in human instrumented posterolateral lumbar fusion through radiographic examination, surgical exploration, and histologic assessment. The use of osteoinductive agents is a current topic in spinal fusion. Numerous preclinical investigations have demonstrated efficacy of osteoinductive proteins in spinal fusion, but few human clinical studies have been reported. Nineteen patients with L3-L4 or L4-L5 degenerative spondylolisthesis underwent posterolateral lumbar fusion using pedicle screw instrumentation. The patients were randomized to receive either OP-1 Putty (3.5 mg OP-1/g of collagen matrix per side) alone (n = 9), or local autograft with HA-TCP granules (n = 10). Fusion status was evaluated using plain radiography and CT scan. Radiographic fusion criteria included less than 5 degrees of angular motion, less than 2 mm of translation, and evidence of bridging bone in the posterolateral lumbar area in which the graft materials were placed following decortication. After a minimum 1-year follow-up, the patients who showed radiographic evidence of fusion underwent instrumentation removal a...Continue Reading

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