A Randomized Controlled Trial Evaluating Efficacy and Complications of Low-Dose rhBMP-2 for Anterior Cervical Diskectomy and Fusion.

Abstract

The aim of this study was to assess the effectiveness and safety of rhBMP-2 compared with iliac bone graft in anterior cervical diskectomy and fusion (ACDF) for cervical degeneration disease. In our study, a total of 1100 patients who underwent 1- or 2-level ACDF procedures between 2013 and 2018 at 6 participating centers in China were included. The patients were divided into 2 groups: the rhBMP-2 group and the iliac crest bone graft group. A dosage of 0.5 mg of rhBMP-2 per level was used in the ACDF procedure. Perioperative parameters such as blood loss, operation time, and complications were recorded. Clinical indices were also investigated. Postoperative plain radiographs were taken at 3 days, 1, 3, 6, and 12 months, and the patients were followed up for a minimum of 5 years. Both the BMP group and the iliac crest bone graft group had similar preoperative baseline data. There was a statistically significant difference ( P < .05) in estimated blood loss between the 2 groups. The fusion rate showed a significant difference at the 3-month follow-up but no difference at 6 months after surgery. There were no significant differences in Visual Analog Scale or Japanese Orthopedic Association scores between the 2 groups ( P > .05). The incidence and severity of dysphagia in the 2 groups were also not significantly different ( P > .05). Prevertebral soft tissue thickness measurements at each cervical level showed a significant difference between the 2 groups at 3 days and 1 month. The symptoms of dysphagia and prevertebral soft tissue swelling gradually disappeared during the subsequent follow-up periods. Low-dose rhBMP-2 can be used as a substitute for autologous bone transplantation to promote cervical spine fusion and meet the fusion requirements.