Complications With Recombinant Human Bone Morphogenic Protein-2 in Posterolateral Spine Fusion

Department of Orthopaedic Surgery, Louisville, KY, USA.
Spine (Impact Factor: 2.3). 10/2011; 36(22):1849-54. DOI: 10.1097/BRS.0b013e3181d133d0
Source: PubMed


Retrospective case series.
The purpose of this study was to report on a large consecutive series of posterolateral fusion cases using rhBMP-2/ACS.
Despite evidence that rhBMP-2/ACS is effective as an iliac crest graft substitute in posterolateral fusion, concerns remain regarding potential risk for BMP use in clinical practice. These concerns have been fueled by the serious complications reported with BMP in anterior cervical spine fusion. While none of the literature on posterolateral fusion with rhBMP-2/ACS has suggested an increased complication rate versus iliac crest bone graft, this issue has not been specifically studied.
We reviewed medical records for a consecutive series of 1037 patients who underwent posterolateral spine fusion using rhBMP-2 between 2003 and 2006. Medical complications were attributed to the surgical procedure if they occurred within the 3-month perioperative period, whereas complications potentially related to BMP were included regardless of time frame.
Medical and surgical complications were observed in 190 of 1037 patients (18.3%) with 81 major complications (7.8%) and 110 minor complications (10.2%). Neurologic complications were related to screw malposition in 6 patients and epidural hematoma in 3 patients. New or more severe postoperative radicular symptoms were noted in 7 patients (0.7%). Psoas hematoma was identified by CT scan in 8 patients (0.8%). Complications directly related to rhBMP-2 were observed in at least 1 patient (0.1%) and in a worst case analysis, in as many as 6 patients (0.6%).
This study in 1037 patients confirms the relative safety of rhBMP-2/ACS for posterolateral spine fusion. There were extremely few complications directly attributed to rhBMP-2/ACS, and the overall complication rates were consistent with established norms. The stark contrast between this experience and the markedly elevated complication rate reported with anterior cervical BMP usage emphasizes the need to evaluate risks and benefits of bioactive technologies in a site-specific and procedure-specific manner.

17 Reads
  • Source
    • "These approaches often utilize a cell-laden three-dimensional (3-D) scaffold, which provides structural support and instructive cues. One such strategy involves delivery of osteoinductive growth factors, such as recombinant bone morphogenetic proteins (BMPs), with recombinant human BMP-2 (rhBMP- 2) and BMP-7 (rhBMP-7) currently approved for clinical use in various parts of the world [3] [4]. While BMPs are powerful inducers of bone tissue formation and delivery of BMPs leads to favorable clinical outcome through bone regeneration, the BMP-mediated bone tissue repair suffers from a number of shortcomings. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Advances in tissue engineering have offered new opportunities to restore anatomically and functionally compromised tissues. Although traditional tissue engineering approaches that utilize biomaterials and cells to create tissue constructs for implantation or biomaterials as a scaffold to deliver cells are promising, strategies that can activate endogenous cells to promote tissue repair are more clinically attractive. Here, we demonstrate that an engineered injectable matrix mimicking a calcium phosphate (CaP)-rich bone-specific microenvironment can recruit endogenous cells to form bone tissues in vivo. Comparison of matrix alone with that of bone marrow-soaked or bFGF-soaked matrix demonstrate similar extent of neo-bone formation and bridging of decorticated transverse processes in a posterolateral lumbar fusion rat model. Synthetic biomaterials that stimulate endogenous cells without the need for biologics to assist tissue repair could circumvent limitations associated with conventional tissue engineering approaches, including ex vivo cell processing and laborious efforts, thereby accelerating the translational aspects of regenerative medicine. Copyright © 2015. Published by Elsevier Ltd.
    Full-text · Article · Mar 2015 · Acta biomaterialia
  • Source
    • "Recently, recombinant human bone morphogenic protein-2 (rhBMP-2) has been used in ACDF. It still remains controversial with regard to safety in spine surgery, but additional use of rhBMP-2 may promote bone fusion after surgery7,17). "
    [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate radiologic result of anterior cervical discectomy and fusion with allobone graft and plate augmentation, and the change of radiologic outcome between screw type and insertion angle. Retrospective review of clinical and radiological data of 29 patients. Segmental angle, height and screw angles were measured and followed. The fusion rate was assessed by plain radiography and CT scans. We divided the patients into two groups according to screw type and angles. Group A: fixed screw, Group B: variable screw. Interscrew angle was measured between most upper and lower screws with Cobb's methods. Overall fusion rate was 86.2% on plain radiography. Fusion was also assessed by CT scan and Bridwell's grading system. There was no difference in fusion and subsidence rates between two groups. Subsidence was found in 5 patients (17.2%). Segmental lordotic angle was increased from preoperative status and maximized at the immediate postoperative period and then reduced at 1 year follow up. Segmental height showed similar increase and decrease values. ACDF with allograft and plate showed favorable fusion rates, and the screw type and angle did not affect results of surgery.
    Full-text · Article · Sep 2013
  • [Show abstract] [Hide abstract]
    ABSTRACT: INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP-2]; Medtronic, Memphis, TN, USA) is approved by the Federal Drug Administration (FDA) only for use with the lumbar tapered fusion device (LT Cage; Medtronic) to perform single-level anterior lumbar interbody fusions (ALIF: L2-S1 levels). INFUSE, however, is widely utilized in an "off-label" capacity for anterior and/or posterior cervical, thoracic, and lumbar surgery. Nevertheless, Medicare and other insurance companies, are now increasingly denying reimbursement (average cost of a "large" INFUSE to the hospital without overhead $5000-6000) to hospitals for INFUSE when utilized "off-label". This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors. There are multiple cons of utilizing INFUSE in an "off-label" capacity for spinal surgery. Direct contraindications include pregnancy, allergy to titanium, allergy to bovine type I collagen or rhBMP-2, infection, tumor, liver or kidney disease, immunosuppression (e.g., lupus, HIV/AIDS); contraindications are also seen in those receiving radiation, chemotherapy, or steroids. Reported complications include exuberant/ectopic bone formation, paralysis (cord, nerve damage), dural tears, bowel-bladder and sexual dysfunction, respiratory failure, inflammation of adjacent tissues, fetal developmental complications, scar, excessive bleeding, and even death. Complications are so prevalent in the anterior cervical spine, that many surgeons no longer use it in this region. Similarly, INFUSE complications and indications for posterior lumbar interbody fusions (PLIFs) and transforaminal interbody lumbar fusions (TLIFs) should also be reexamined. More surgeons need to question the safety, efficacy, and appropriate "off-label" use of INFUSE in all spine surgeries.
    No preview · Article · Jan 2011 · Surgical Neurology International
Show more