title: Anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2: a prospective study of complications.
abstract: OBJECTIVE
  The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in anterior lumbar interbody fusion (ALIF) is controversial regarding the reported complication rates and cost. The authors aimed to assess the complication rates of performing ALIF using rhBMP-2.
  
  
  METHODS
  This is a prospective study of consecutive patients who underwent ALIF performed by a single spine surgeon and a single vascular surgeon between 2009 and 2012. All patients underwent placement of a polyetheretherketone (PEEK) cage filled with rhBMP-2 and a separate anterior titanium plate. Preoperative clinical data, operative details, postoperative complications, and clinical and radiographic outcomes were recorded for all patients. Clinical outcome measures included back and leg pain visual analog scale scores, Oswestry Disability Index (ODI), and SF-36 Physical and Mental Component Summary (PCS and MCS) scores. Radiographic assessment of fusion was performed using high-definition CT scanning. Male patients were screened pre- and postoperatively regarding sexual dysfunction, specifically retrograde ejaculation (RE).
  
  
  RESULTS
  The study comprised 131 patients with a mean age of 45.3 years. There were 67 men (51.1%) and 64 women (48.9%). Of the 131 patients, 117 (89.3%) underwent ALIF at L5-S1, 9 (6.9%) at L4-5, and 5 (3.8%) at both L4-5 and L5-S1. The overall complication rate was 19.1% (25 of 131), with 17 patients (13.0%) experiencing minor complications and 8 (6.1%) experiencing major complications. The mean estimated blood loss per ALIF level was 115 ml. There was 1 incidence (1.5%) of RE. No significant vascular injuries occurred. No prosthesis failure occurred with the PEEK cage and separate anterior screw-plate. Back and leg pain improved 57.2% and 61.8%, respectively. The ODI improved 54.3%, with PCS and MCS scores improving 41.7% and 21.3%, respectively. Solid interbody fusion was observed in 96.9% of patients at 12 months.
  
  
  CONCLUSIONS
  Anterior lumbar interbody fusion with a vascular access surgeon and spine surgeon, using a separate cage and anterior screw-plate, provides a very robust and reliable construct with low complication rates, high fusion rates, and positive clinical outcomes, and it is cost-effective. The authors did not experience the high rates of RE reported by other authors using rhBMP-2.
authors.affiliation: Neuroscience Institute, and 
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Malham
authors.forename: Rhiannon M
authors.initials: RM
authors.lastname: Parker
authors.forename: Ngaire J
authors.initials: NJ
authors.lastname: Ellis
authors.forename: Carl M
authors.initials: CM
authors.lastname: Blecher
authors.forename: Fiona Y
authors.initials: FY
authors.lastname: Chow
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Claydon
mesh_terms: D000328:Adult; D000368:Aged; D001577:Benzophenones; D055396:Bone Morphogenetic Protein 2 / Q000627:therapeutic use*; D001860:Bone Plates; D001863:Bone Screws; D004542:Ejaculation; D007172:Erectile Dysfunction / Q000209:etiology*; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000601:surgery; D007659:Ketones; D017116:Low Back Pain / Q000209:etiology* / Q000601:surgery; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011108:Polymers; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012447:Sacrum / Q000601:surgery; D013123:Spinal Fusion / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods*; D014025:Titanium; D016212:Transforming Growth Factor beta / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001577:Benzophenones; D055396:Bone Morphogenetic Protein 2; D007659:Ketones; D011108:Polymers; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2; C063834:polyetheretherketone; D011092:Polyethylene Glycols; D014025:Titanium
keywords: ALIF; ALIF = anterior lumbar interbody fusion; DVT = deep venous thrombosis; EBL = estimated blood loss; HD = high-definition; ICBG = iliac crest bone graft; MCS = Mental Component Summary; ODI = Oswestry Disability Index; PCS = Physical Component Summary; PEEK = polyether-etherketone; RE = retrograde ejaculation; SHP = superior hypogastric plexus; UTI = urinary tract infection; VAS = visual analog scale; complications; cost; fusion; lumbar; retrograde ejaculation; rhBMP-2; rhBMP-2 = recombinant human bone morphogenetic protein–2