title: A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: report on safety and feasibility.
abstract: METHODS
  A prospective, randomized, controlled, multicenter clinical study.
  
  
  OBJECTIVE
  To evaluate the safety and feasibility of osteogenic protein (OP)-1 in 1-level lumbar spine instrumented posterolateral fusions.
  
  
  BACKGROUND
  Instrumented posterolateral fusion with the use of autograft is a commonly performed procedure for a variety of spinal disorders. However, harvesting of bone from the iliac crest is associated with complications. A promising alternative for autograft are bone morphogenetic proteins.
  
  
  METHODS
  As part of a larger prospective, randomized, multicenter study, 36 patients were included, who received a 1-level instrumented posterolateral fusion of the lumbar spine. All patients had a degenerative or isthmic spondylolisthesis with symptoms of neurologic compression. There were 2 treatment arms: OP-1 combined with locally available bone from laminectomy (OP-1 group) or iliac crest autograft (autograft group). The primary outcome was the fusion rate based on a computed tomography scan after 1-year follow-up. The clinical outcome was measured using the Oswestry Disability Index. Additionally, the safety of OP-1 was evaluated by comparing the number and severity of adverse events that occurred between both groups.
  
  
  RESULTS
  Using strict criteria, fusion rates of 63% were found in the OP-1 group and 67% in the control group (P = 0.95). There was a decrease in Oswestry scores at subsequent postoperative time points compared with preoperative values (P > 0.001). There were no significant differences in the mean Oswestry scores between the study group and control group at any time point (P = 0.56). No product-related adverse events occurred.
  
  
  CONCLUSIONS
  The results demonstrate that OP-1 combined with locally obtained autograft is a safe and effective alternative for iliac crest autograft in instrumented single-level posterolateral fusions of the lumbar spine. The main advantage of OP-1 is that it avoids morbidity associated with the harvesting of autogenous bone grafts from the iliac crest.
authors.affiliation: Department of Orthopaedics, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Delawi
authors.forename: W J A
authors.initials: WJ
authors.lastname: Dhert
authors.forename: L
authors.initials: L
authors.lastname: Rillardon
authors.forename: E
authors.initials: E
authors.lastname: Gay
authors.forename: D
authors.initials: D
authors.lastname: Prestamburgo
authors.forename: C
authors.initials: C
authors.lastname: Garcia-Fernandez
authors.forename: E
authors.initials: E
authors.lastname: Guerado
authors.forename: N
authors.initials: N
authors.lastname: Specchia
authors.forename: J L C
authors.initials: JL
authors.lastname: Van Susante
authors.forename: N
authors.initials: N
authors.lastname: Verschoor
authors.forename: H M E Quarles
authors.initials: HM
authors.lastname: van Ufford
authors.forename: F C
authors.initials: FC
authors.lastname: Oner
mesh_terms: D000328:Adult; D000368:Aged; D055419:Bone Morphogenetic Protein 7 / Q000008:administration & dosage* / Q000009:adverse effects*; D016025:Bone Transplantation / Q000009:adverse effects / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000139:chemically induced / Q000209:etiology; D006801:Humans; D007085:Ilium / Q000637:transplantation; D008159:Lumbar Vertebrae / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013123:Spinal Fusion / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D013168:Spondylolisthesis / Q000188:drug therapy / Q000601:surgery; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D055419:Bone Morphogenetic Protein 7