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High-dose BMP-2 and strong carrier enhance posterolateral lumbar fusion

A large-scale study shows the combination reduces pain as well as need for iliac crest bone grafting.

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SEATTLE — A durable implant device coated with recombinant human bone morphogenetic protein-2 at a dose slightly above the FDA-approved concentration reduced both surgical time and blood loss during lumbar fusion, a multicenter study found.

John Dimar II, MD, and colleagues at the Spine Institute for Special Surgery in Louisville, Ky., and at centers in Atlanta and in Columbus, Ga., evaluated the Amplify Matrix (Medtronic Sofamor Danek) in a prospective, nonblinded study of 463 patients.

The Amplify Matrix is a compressive resistant matrix (CRM) carrier designed to withstand the rigors of posterolateral lumbar fusion (PLF). In the study, researchers randomized 239 patients to treatment with the device containing a 2 mg/cc dose of recombinant human bone morphogenetic protein-2 (rhBMP-2). The remaining 224 patients were randomized to a control group that received iliac crest bone graft.

All patients had symptomatic single-level degenerative disc disease with grade 1 spondylolisthesis. Additionally, the protocol required all patients to be able to undergo decompression and instrumented single-level PLF, according to Dimar, who presented the study results at the North American Spine Society 21st Annual Meeting, here.

Dimar noted that rhBMP-2 dose used was "slightly higher" than that used for the Infuse bone graft substitute (Medtronic Sofamor Danek), which the FDA previously approved for anterior lumbar interbody fusion.

The researchers found that rhBMP-2-treated patients had significantly lower rates of blood loss during surgery. For these patients, blood loss averaged 343.1 mL compared to 448.6 mL for control patients (P<.001).

Additionally, the matrix significantly reduced operative time, which averaged 2.5 hours for rhBMP-2-treated patients compared to 2.9 hours for control patients (P<.001), according to the study.

Both groups achieved similar rates of fusion. At 12 months' follow-up, 87.4% of rhBMP-2-treated patients and 82.4% of control patients showed evidence of fusion (P=.1992). At 2 years, fusion rates reached 94.9% for rhBMP-2-treated patients and 86.8% for control patients (P=.0737), Dimar said.

For more information:

• Dimar J, Glassman SD, Burkus JK, et al. A large-scale, level 1, clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine fusion. #2. Presented at the North American Spine Society 21st Annual Meeting. Sept. 26-30, 2006. Seattle.