STUDY DESIGN: A prospective, randomized and controlled study. OBJECTIVES: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS:Nineteen patients with L3-L4 or L4-L5 degenerative spondylolisthesis underwentposterolateral lumbar fusion using pedicle screw instrumentation. The patients were randomized to receive either OP-1Putty (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 and surgical exploration of the fusion site. Biopsy specimens were taken from the fusion mass and evaluated histologically. RESULTS:Radiographic fusion rate was 7 of 9 OP-1 patients and 9 of 10 control patients. Based on surgical exploration of these 16 patients, new bone formation was macroscopically observed in the posterolateral lumbar region in all cases; however, solid fusion was observed in 4 of 7OP-1 and 7 of 9 HA-TCP/autograft patients. Histologic assessment demonstrated viable bone in 6 of 7 OP-1 patients. All the control (HA-TCP/autograft) specimens contained viable bone and fibrous tissue surrounding ceramic granules, suggesting slow incorporation of the graft material. CONCLUSIONS: In a human posterolateral lumbar spine trial, OP-1 reliably induced viable amounts of new bone formation, but the fusion success rate evaluated by surgical exploration was only 4 of 7.
RCT Entities:
STUDY DESIGN: A prospective, randomized and controlled study. OBJECTIVES: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS: 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 and surgical exploration of the fusion site. Biopsy specimens were taken from the fusion mass and evaluated histologically. RESULTS: Radiographic fusion rate was 7 of 9 OP-1patients and 9 of 10 control patients. Based on surgical exploration of these 16 patients, new bone formation was macroscopically observed in the posterolateral lumbar region in all cases; however, solid fusion was observed in 4 of 7OP-1 and 7 of 9 HA-TCP/autograft patients. Histologic assessment demonstrated viable bone in 6 of 7 OP-1patients. All the control (HA-TCP/autograft) specimens contained viable bone and fibrous tissue surrounding ceramic granules, suggesting slow incorporation of the graft material. CONCLUSIONS: In a human posterolateral lumbar spine trial, OP-1 reliably induced viable amounts of new bone formation, but the fusion success rate evaluated by surgical exploration was only 4 of 7.
Authors: Abhijeet Kadam; Paul W Millhouse; Christopher K Kepler; Kris E Radcliff; Michael G Fehlings; Michael E Janssen; Rick C Sasso; James J Benedict; Alexander R Vaccaro Journal: Int J Spine Surg Date: 2016-09-22