The safety and efficacy of anterior cervical discectomy and fusion with polyetheretherketone spacer and recombinant human bone morphogenetic protein-2: A review of 200 patients

Department of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Journal of Neurosurgery Spine (Impact Factor: 2.38). 06/2008; 8(6):529-35. DOI: 10.3171/SPI/2008/8/6/529
Source: PubMed


The goal in this study was to demonstrate the safety and efficacy of anterior cervical discectomy and fusion ([ACDF]; single- or multilevel procedure) performed using titanium plates and polyetheretherketone (PEEK) spacers filled with recombinant human bone morphogenetic protein-2 (rhBMP-2) impregnated in a type I collagen sponge to achieve fusion.
The authors retrospectively reviewed 200 patients who underwent a single- or multilevel ACDF with titanium plate fixation and PEEK spacer filled with a collagen sponge impregnated with low-dose rhBMP-2. Clinical outcomes were assessed using pre- and postoperative Nurick grades and the Odom criteria. Radiographic outcomes were assessed using dynamic radiographs and computed tomography (CT) scans.
The follow-up period ranged from 8 to 36 months (mean 16.7 months). A single-level ACDF was performed in 96 patients, 2-level ACDF in 62 patients, 3-level ACDF in 36 patients, and 4-level ACDF in 6 patients. Long-term follow-up was available for 193 patients. The Odom outcomes were rated as good to excellent in 165 patients (85%), fair in 24 (12.4%), and poor in 4 (2%). Among patients with myelopathy, Nurick grades improved from a preoperative mean of 1.42 to a postoperative mean of 0.26. All patients (100%) achieved solid radiographic fusion on dynamic radiographs and CT scans. Fourteen patients (7%) in this series experienced clinically significant dysphagia, and 4 (2%) required repeated operation for hematoma or seroma.
An ACDF performed using a PEEK spacer filled with rhBMP-2 leads to good to excellent clinical outcomes and solid fusion, even in multilevel cases and in patients who are smokers. The incidence of symptomatic dysphagia may be decreased with a lower dose of rhBMP-2 that is placed only within the PEEK spacer.

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    • "Adjunctive use of growth factors requires supraphysiologic doses to overcome diffusion away from the implantation site (Walker and Wright, 2002), further exacerbating the potential for adverse effects. Indeed, native bone resorption, implant fracture, soft-tissue swelling, osseous overgrowth, inflammation, and other complications at and away from implant sites have been linked to BMP therapy (Riew et al., 1998; Poynton and Lane, 2002; Haid et al., 2004; Shields et al., 2006; Smucker et al., 2006; Perri et al., 2007; Vaidya et al., 2007; Tumialan et al., 2008). Treatments with other growth factors have been explored, but most have limited osteoinductive capacity (Laurencin et al., 1999). "
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    ABSTRACT: Efforts to enhance bone regeneration in orthopedic and dental cases have grown steadily for the past decade, in line with increasingly sophisticated regenerative medicine. To meet the unprecedented demand for novel osteospecific growth factors with fewer adverse effects compared with those of existing adjuncts such as BMPs, our group has identified a craniosynostosis-associated secreted molecule, NELL-1, which is a potent growth factor that is highly specific to the osteochondral lineage, and has demonstrated robust induction of bone in multiple in vivo models from rodents to pre-clinical large animals. NELL-1 is preferentially expressed in osteoblasts under direct transcriptional control of Runx2, and is well-regulated during skeletal development. NELL-1/Nell-1 can promote orthotopic bone regeneration via either intramembranous or endochondral ossification, both within and outside of the craniofacial complex. Unlike BMP-2, Nell-1 cannot initiate ectopic bone formation in muscle, but can induce bone marrow stromal cells (BMSCs) to form bone in a mouse muscle pouch model, exhibiting specificity that BMPs lack. In addition, synergistic osteogenic effects of Nell-1 and BMP combotherapy have been observed, and are likely due to distinct differences in their signaling pathways. NELL-1's unique role as a novel osteoinductive growth factor makes it an attractive alternative with promise for future clinical applications. [Note: NELL-1 and NELL-1 indicate the human gene and protein, respectively; Nell-1 and Nell-1 indicate the mouse gene and protein, respectively.]
    Preview · Article · Sep 2010 · Journal of dental research
    • "Reports have included painful seroma requiring return to the operating room for evacuation.[41] There have also been reports of tissue swelling and airway compromise, particularly in the anterior cervical spine.[31–3342] The use of surgical wound drains in cases using osteoinductive products as adjuncts to fusion was not consistently documented in all patients in the above studies. "
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    ABSTRACT: There have been few reports on the use of recombinant human bone morphogenetic protein (rhBMP)-2 in posterior spine. However, no study has investigated the dosing, safety, and efficacy of its use in the posterior atlantoaxial, and/or craniovertebral junction. Recent case report of the cytokine-mediated inflammatory reaction, following off label use of rhBMP-2 as an adjunct for cervical fusion, particularly in complex cases, has increased concern about complications associated with the product. To assess the safety, efficacy, and dosing of rhBMP-2 as an adjunct for instrumented posterior atlantoaxial and/or craniovertebral junction arthrodesis. We included all patients treated by the senior author that included posterior atlantoaxial and/or craniovertebral junction instrumented fusion using rhBMP-2 from 2003 to 2008 with a minimum two year follow-up. Diagnosis, levels fused, rhBMP-2 dose, complications, and fusion were assessed. Twenty three patients with a mean age of 60.9 years (range 4 - 89 years) and an average follow-up of 45 months (range 27 to 84 months) met inclusion criteria. The indications for surgery included, atlantoaxial instability (n = 16), basilar invagination (n = 6), and kyphoscoliosis (n = 1). The specific pathologic diagnosis included type 2 dens fracture (n = 7), complex C1 and C2 ring fracture (n = 2), chordoma (n = 2), degenerative/osteoporosis (n = 3), rheumatoid disease (n = 8), and pseudogout (n = 1). The average rhBMP-2 dose was 2.38 mg/level, with a total of 76 levels treated (average 3.3 levels, SD= 1.4 levels). There were no complications. During the most recent follow-up, all patients had achieved fusion. In a series of patients with complex pathology and/or rheumatoid arthritis, 100% fusion rate was achieved with adjunct use of rhBMP-2, with a safe and effective average rhBMP-2 dose of 2.38 mg per level.
    No preview · Article · Jul 2010 · Journal of craniovertebral junction and spine
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    ABSTRACT: [article in greek] PURPOSE To study the effectiveness of a new synthetic material (Polyetheretherketone – PEEK) that was used for the treatment of cervical discopathy in 1 or 2 levels. METHODOLOGY 18 patients ranging 29 to 72 years old, (median 47.7 years, 9 male, 9 female) were treated the past 2.5 years with cervical disk herniation in one or two levels, using PEEK cages. The patients were treated with frontal microsurgical cervical discectomy in one or two levels, without the use of plate in 17 cases and with the use of a plate in 1 case. The follow-up period post-surgically ranged from 9 to 26 months and consisted of clinical examinations, cervical x-rays F+P and flexion-extension x-rays. RESULTS All patients showed clinical amelioration. Patients with root syndrome (rhizopathy) and cervical pain showed improvement of the symptoms. Patients with myelopathy also showed important improvement based on the Nurick scale. Imaging control did not show any material migration while the percentage of accomplished bone fusion was 100%. CONCLUSIONS Frontal microsurgical cervical discectomy with the use of PEEK cages is a safe and effective procedure. Long-term follow-up is needed to extract final conclusions on possible complications of the method using the particular material (cage migration, adjacent level disease etc).
    Full-text · Article · Sep 2008
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