A consensus statement regarding the utilization of BMP in spine surgery.

Area of Science:

• Orthopedics
• Biomaterials Science
• Spinal Surgery

Background:

• Recombinant human bone morphogenetic protein-2 (rh-BMP-2) received FDA approval in 2002 for anterior lumbar interbody fusions.
• Off-label rh-BMP-2 applications are estimated to constitute 85% of its current use.
• Initial industry-sponsored studies reported superior fusion rates and fewer complications compared to iliac crest bone graft.

Purpose of the Study:

• To evaluate the efficacy and safety of rh-BMP-2 in various off-label spinal fusion applications.
• To analyze fusion rates, complications, and clinical/radiographic outcomes for these uses.
• To critically assess existing literature regarding rh-BMP-2's expanded applications.

Main Methods:

• Literature review of studies on rh-BMP-2 use in spinal fusions.
• Focus on anterior lumbar, posterior lumbar (single and multiple levels), posterior cervical, and long deformity fusions.
• Inclusion of studies involving patients with vertebral osteomyelitis or a history of malignancy.

Main Results:

• While initial studies suggested benefits, newer research highlights potential complications associated with rh-BMP-2.
• Fusion rates and outcomes vary significantly across different off-label applications.
• Evidence regarding safety and efficacy in complex cases (e.g., osteomyelitis, malignancy) requires further investigation.

Conclusions:

• The off-label use of rh-BMP-2 in spinal fusions presents a complex picture with both potential benefits and risks.
• Critical evaluation of existing data is necessary due to potential bias in early studies.
• Further research is warranted to establish clear guidelines for rh-BMP-2 use in diverse clinical scenarios.