(HealthDay News) — Patients receiving high-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) as part of spine surgery have an increased risk of cancer and may be at risk for major complications, according to two studies published in the Sept. 4 issue of The Journal of Bone & Joint Surgery.
In an effort to examine the risk of new cancers in patients receiving high-dose rhBMP-2, Eugene J. Carragee, MD, from the Stanford University School of Medicine in Redwood City, Calif., and colleagues used data from a multicenter trial involving patients with degenerative lumbar spine conditions who underwent single-level instrumented posterolateral arthrodesis with high-dose rhBMP-2 in a compression-resistant matrix (rhBMP-2/CRM; 239 patients) or autogenous bone graft (control; 224 patients).
The researchers found that the incidence rate of new cancer events was 3.37 per 100 person-years in the rhBMP-2/CRM group versus 0.50 in the control group (incidence rate ratio, 6.75 at 2 years). At five years, the incidence of cancer events was still significantly greater in the rhBMP-2/CRM group.
Addisu Mesfin, M.D., from the University of Rochester in New York, and colleagues examined the short- and long-term outcomes and medical and surgical complications linked to high-dose rhBMP-2 in a cohort of 502 patients who received high-dose rhBMP-2 as part of spinal surgery.
The researchers found that the rates of intraoperative complications, perioperative major surgical complications, and perioperative major medical complications were 8.2%, 11.6%, and 11.6%, respectively. No significant association was found for rhBMP-2 with radiculopathy, seroma, or cancer.
“Major surgical complications occurred in 11.6% of patients, and 11.6% experienced major medical complications,” Mesfin and colleagues write.
One or more authors from both studies, or their institutions, disclosed a financial tie with an entity in the biomedical arena.