Bezeotermin Alfa (rhBMP-6) Administration in Lumbar Interbody Fusion Surgery Using a Posterior Approach: A...

Area of Science:

• Orthopedics
• Spinal Surgery
• Regenerative Medicine

Background:

• Novel therapies are needed for posterior-based lumbar interbody fusion.
• Bezeotermin alfa (recombinant human bone morphogenetic protein-6) is a potential bone regeneration stimulator.

Purpose of the Study:

• Evaluate the safety and preliminary efficacy of bezeotermin/autologous blood coagulum (ABC) in lumbar interbody fusion.
• Assess bezeotermin's potential in stimulating bone regeneration for spinal fusion.

Main Methods:

• Prospective, randomized, double-blinded, placebo-controlled Phase-2 trial.
• Adult patients undergoing single-level lumbar interbody fusion were randomized to placebo or bezeotermin (0.25 mg or 0.5 mg).
• Primary endpoint: adverse events; Secondary endpoints: fusion success, Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) pain scores.

Main Results:

• All patients experienced mild to moderate adverse events; no drug-related serious adverse events were reported.
• A trend towards higher radiographic fusion rates was observed in bezeotermin groups.
• Improved ODI and VAS scores were noted in bezeotermin groups compared to placebo from month 3 to 12.

Conclusions:

• Bezeotermin/ABC is safe and well-tolerated in posterior-based single-level lumbar interbody fusion.
• Preliminary efficacy suggests bezeotermin accelerates spinal fusion and improves clinical outcomes.
• Further clinical development of bezeotermin for lumbar fusion is supported.