Does Bone Morphogenetic Protein Use Reduce Pseudarthrosis Rates in Single-Level Transforaminal Lumbar Interbody Fusion Surgeries?

Abstract

Recombinant human bone morphogenetic protein 2 (rhBMP-2, or BMP for short) is a popular biological product used in spine surgeries to promote fusion and avoid the morbidity associated with iliac crest autograft. BMP's effect on pseudarthrosis in transforaminal lumbar interbody fusion (TLIF) remains unknown. To assess the rates of pseudarthrosis in single-level TLIF with and without concurrent use of BMP. This was a retrospective cohort study conducted at a single academic institution. Adults undergoing primary single-level TLIF with a minimum of 1 year of clinical and radiographic follow-up were included. BMP use was determined by operative notes at index surgery. Non-BMP cases with iliac crest bone graft were excluded. Pseudarthrosis was determined using radiographic and clinical evaluation. Bivariate differences between groups were assessed by independent t test and χ 2 analyses, and perioperative characteristics were analyzed by multiple logistic regression. One hundred forty-eight single-level TLIF patients were included. The mean age was 59.3 years, and 52.0% were women. There were no demographic differences between patients who received BMP and those who did not. Pseudarthrosis rates in patients treated with BMP were 6.2% vs 7.5% in the no BMP group (P = 0.756). There was no difference in reoperation for pseudarthrosis between patients who received BMP (3.7%) vs those who did not receive BMP (7.5%, P = 0.314). Patients who underwent revision surgery for pseudarthrosis more commonly had diabetes with end-organ damage (revised 37.5% vs not revised 1.4%, P < 0.001). Multiple logistic regression analysis demonstrated no reduction in reoperation for pseudarthrosis related to BMP use (OR 0.2, 95% CI 0.1-3.7, P = 0.269). Diabetes with end-organ damage (OR 112.6,95% CI 5.7-2225.8, P = 0.002) increased the risk of reoperation for pseudarthrosis. BMP use did not reduce the rate of pseudarthrosis or the number of reoperations for pseudarthrosis in single-level TLIFs. Diabetes with end-organ damage was a significant risk factor for pseudarthrosis. BMP is frequently used "off-label" in transforaminal lumbar interbody fusion; however, little data exists to demonstrate its safety and efficacy in this procedure.