A Large-Scale, Level 1, Clinical And Radiographic Analysis of an Optimized rhBMP-2 Formulation as an Autograft Replacement in Posterolateral Lumbar Spine Fusion

Purpose: To determine the feasibility of using recombinant human bone morphogenetic protein-2 with a compression resistant matrix (rhBMP-2/CRM) as an iliac crest bone graft (ICBG) substitute in patients undergoing posterolateral fusion.

Methods: In this ongoing prospective study, 463 patients with symptomatic single-level degenerative disc disease with ? Grade1 spondylolisthesis were treated with decompression and instrumented single-level posterolateral fusion through an open midline approach. Patients were randomly assigned to either the rhBMP-2/CRM (AMPLIFY™, Medtronic Sofamor Danek) group (239 patients) or the ICBG group (224 patients). ODI, SF-36, and back and leg pain scores were determined preoperatively and at 1.5, 3, 6, 12 and 24 months postoperatively. Two independent radiologists reviewed radiographs and CT scans taken at 6, 12, and 24 months postoperatively. Fusion was defined as the presence of bilateral, continuous trabeculated bone connecting the transverse processes and translation of ?3 mm and angulation of <5 ° on flexion-extension radiographs.

Results: No significant differences in demographics existed between the groups. Mean operative time in the rhBMP-2 group (2.5 hours) was less than in the ICBG group (2.9 hours) (p<0 .001). Average blood loss in the rhBMP-2 group was 343.1 mL compared with 448.6 ICBG (p<0.001). hospital stay similar both groups. No differences existed between groups adverse events except nonunion rate lower (2.5%;6 patients) than (7.1%;16 (p="0.0737)." At 12 months, 87.4% of patients and 82.4% had evidence fusion 24 94.9% were fused 86.8% Both showed improvements clinical outcomes reduced pain.

Conclusions: The use of rhBMP-2 can eliminate the need for harvesting iliac crest bone in successful posterolateral lumbar fusions.

** The FDA has not cleared a drug and/or medical device described in this presentation (i.e., the drug or medical device is being discussed in an (off-label use.)

Hibbs Award Nominee for Best Clinical Paper