ACTIFUSE: the evidence, the handling, and a trial case in your OR

Using ACTIFUSE since 2014. More than 2,000 patients fused.

Comparable arthrodesis to rhBMP-2, without the biologic

Coughlan, Spine 2018, randomized, 103 patients, Baxter funded and disclosed: fusion equivalent at 24 months, 80.4% vs 80.4% intent-to-treat, VAS back pain lower in the SiCaP arm at every time point and significant at six months. Serious device-related events even, 7.8% vs 7.7%.

The Hopkins authors call their pooled data heterogeneous, I-squared 82%, largely level IV. We quote that so you do not have to find it. Neither study shows superiority on fusion and we will not claim it. What the data supports: comparable arthrodesis, standalone performance independent of crest harvest, on-label use for posterolateral fusion with instrumentation.

What the papers do not cover

Shape holds firm cold and extends with a squeeze to span the gutter; it resists irrigation. ABX is sculptable putty in a preloaded syringe. The MIS applicator runs 200 mm deep at 8 mm OD, 0.5 mL per trigger squeeze, bayonet cartridge swaps mid-case.

Not for load-bearing use. Not cleared for vertebroplasty. Full contraindications in the IFU. A rep who glosses over that list is telling you something about the rep.

Their reasons, stated as theirs

• ✓Off the BMP consent conversation: roughly 85% of rhBMP-2 use is off-label
• ✓Off the crest: up to 49% chronic donor-site pain in published series, and the standalone data answers it
• ✓Value analysis pressure: $900 to $5,500 per BMP case inside a fixed DRG
• ✓It stays in the gutter: cohesion surgeons mention unprompted on our OR footage

One trial case. Bring your worst skeptic.

We cover first cases in the OR, in-service your staff on the applicator, and hand your value analysis committee the primary papers, including the payer policies that cut against us. They will find those anyway; better they arrive from you.

If the handling does not earn the next case, we will not chase you.