Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) in Posterolateral Lumbar Spine Fusion: Complications in the Elderly

Abstract

Study design: Retrospective cohort study of 1430 patients undergoing lumbar spinal fusion from 2002 -2009. Objective: The goal of this study was to compare and evaluate the number of complications requiring reoperation in elderly versus younger patients. Summary of background data: rhBMP-2 has been utilized off label for instrumented lumbar posterolateral fusions for many years. Many series have demonstrated predictable healing rates and reoperations. Varying complication rates in elderly patients have been reported. Materials and methods:All patients undergoing instrumented lumbar posterolateral fusion of ≤ 3 levels consenting to utilization of rhBMP-2 were retrospectively evaluated. Patient demographics, body mass index, comorbidities, number of levels, associated interbody fusion, and types of bone void filler were analyzed. The age of patients were divided into less than 65 and greater than or equal to 65 years. Complications related to the performed procedure were recorded. Results: After exclusions, 482 consecutive patients were evaluated with 42.1% males and 57.9% females. Average age was 62 years with 250 (51.9%) < 65 and 232 (48.1%) ≥ 65 years. Patients ≥ 65 years of age stayed longer (5.0 days) in the hospital than younger patients (4.5 days) (p=0.005). Complications requiring reoperation were: acute seroma formation requiring decompression 15/482, 3.1%, bone overgrowth 4/482, 0.8%, infection requiring debridement 11/482, 2.3%, and revision fusion for symptomatic nonunion 18/482, 3.7%. No significant differences in complications were diagnosed between the two age groups. Statistical differences were noted between the age groups for medical comorbidities and surgical procedures. Patients older than 65 years underwent longer fusions (2.1 versus 1.7 levels, p=0.001).Discussion: Despite being older and having more comorbidities, elderly patients have similar complication and reoperation rates compared to younger healthier patients undergoing instrumented lumbar decompression fusions with rhBMP-2.

Trends Analysis of rhBMP2 Utilization in Single-Level Anterior Lumbar Interbody Fusion in the United States

“…However, questions about complications associated with the use of rhBMP2 in humans have been reported. 4 -9 The FDA issued Public Health Notification in 2008 regarding the utilization of rhBMP2 in the anterior cervical spine fusion. 10 The trend of rhBMP2 utilization in single-level ALIF has not yet been reported.…”

Bone morphogenetic protein-2 and bone therapy: successes and pitfalls

“…[32] Seroma formation in lumbar spine fusion is rare but fatal as it leads to inflammation and oedema formation. [31] Another study [33] demonstrated that rhBMP-2 used on elderly patients have similar complications and a risk of increased healing time. In 2008, the FDA issued a public health notification of life-threatening complications such as swelling of the neck and throat and compression of the airway, but further studies still need to be conducted.…”