Effectiveness and Feasibility of Injectable Escherichia coli‐Derived Recombinant Human Bone Morphogenetic Protein‐2 for Anterior Lumbar Interbody Fusion at the Lumbosacral Junction in Adult Spinal Deformity Surgery: A Clinical Pilot Study

OBJECTIVE: To explore the effectiveness and feasibility of injectable Escherichia coli‐derived recombinant human bone morphogenetic protein‐2 (injectable E‐rhBMP‐2, a combination of E. coli‐derived recombinant human bone morphogenic protein‐2 and a hydrogel type beta‐tricalcium phosphate carrier) as a bone substitute for anterior lumbar interbody fusion (ALIF) of the lumbosacral junction in adult spinal deformity (ASD) patients. METHODS: A prospective single‐institution therapeutic exploratory trial was conducted. Twenty patients (average age: 69.1 years; 19 female and one male; average fusion level: 7.95) diagnosed with ASD with sagittal imbalance who underwent surgical treatment including ALIF at the lumbosacral junction from December 2017 to January 2019 were evaluated. Injectable E‐rhBMP‐2 was prepared by dissolving 3 mg of E. coli‐derived recombinant human bone morphogenetic protein‐2 in 1.5 ml H(2)O and mixing in situ with 9 g hydrogel type beta‐tricalcium phosphate. This bone graft substitute was loaded onto a metal ALIF cage and L(5)–S(1) ALIF was performed in routine manner. Then posterior column osteotomy with multilevel oblique lumbar interbody fusion or pedicle subtraction osteotomy with accessory rod technique was performed to restore sagittal balance. Patients were followed up for 12 months. CT‐based fusion rates were examined at 6 and 12 months after surgery. Also, clinical outcomes (Oswestry Disability Index [ODI], Visual Analog Scale [VAS] score of the back and leg) were evaluated at 6 and 12 months after surgery. All postoperative adverse events were evaluated for the association with injectable E.BMP‐2. RESULTS: Of the 20 patients, loss to follow‐up occurred with one patient at 6 months after surgery and one patient at 12 months after surgery, resulting in a total of 18 patients who were available for follow‐up. Six months after surgery, 68.4% patients achieved solid fusion. Twelve months after surgery, 100% fusion rate was achieved. Compared to baseline values, ODI scores improved to 45.8% and 63.7%, VAS (back) improved to 69.2% and 72.8%, and VAS (leg) improved to 49.2% and 64.8%, respectively, at 6 and 12 months after surgery (p < 0.001 for all). Ten cases of adverse events occurred. But no adverse events were associated with injectable E‐rhBMP‐2. CONCLUSION: Injectable E‐rhBMP‐2 will be an effective bone graft substitute when achieving solid interbody fusion in the lumbosacral junction.