title: rhBMP-2 protects against reoperation for pseudoarthrosis and/or instrumentation failure: A matched case-control study of 448 patients.
abstract: The objective of this independent study is to determine the impact of recombinant human bone morphogenetic protein 2 (rhBMP-2) on reoperation for pseudarthrosis and/or instrumentation failure. A nested case-control study of first-time posterolateral, instrumented fusion of the lumbar spine for degenerative spinal disease was undertaken. Cases of reoperation for pseudoarthrosis and/or instrumentation failure were assigned to controls, who did not experience the primary outcome measure at the time of reoperation. Cases and controls were matched on number of interspaces fused and inclusion of interbody. Predictors of reoperation for pseudoarthrosis and/or instrumentation failure were assessed with a conditional logistical regression controlling for rhBMP-2, age, obesity, and smoking. Of the 448 patients, 155 cases of reoperation for pseudoarthrosis and/or instrumentation were matched with 293 controls. Twenty-six percent of first-time surgeries included rhBMP-2, which was statistically more commonly used in the control cohort (33.11%) versus the case cohort (12.90%) (Unadjusted odds ratio [ORunadj]=0.28) (95% confidence interval [CI]: 0.16-0.49). Following a multivariate analysis controlling for age, obesity, and smoking, the rhBMP-2 recipients incurred a 73% lower odds of reoperation for pseudoarthrosis and/or instrumentation failure (95% CI, 0.15-0.48). Neither sarcomatous nor osseous neoplasm was detected in the study population. Mean follow up did not differ between the cases (81.57±standard deviation [SD] 4.98months) versus controls (74.75±2.49month) (ORunadj=1.01) (95% CI: 1.00-1.01). rhBMP-2 in lumbar fusion constructs protects against reoperation for pseudoarthrosis and/or instrumentation failure. However, the decision to include fusion supplements should be weighted between surgical determinants and clinical outcomes.
authors.affiliation: Department of Neurosurgery, Henry Ford Hospital, Detroit, MI 48202, USA; Johns Hopkins Spinal Biomechanics and Surgical Outcomes Laboratory, Baltimore, MD 21287, USA.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Macki
authors.affiliation: Johns Hopkins Spinal Biomechanics and Surgical Outcomes Laboratory, Baltimore, MD 21287, USA.
authors.forename: Sbaa
authors.initials: S
authors.lastname: Syeda
authors.affiliation: Department of Neurosurgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Kerezoudis
authors.affiliation: Johns Hopkins Spinal Biomechanics and Surgical Outcomes Laboratory, Baltimore, MD 21287, USA; Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Bydon
authors.affiliation: Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Witham
authors.affiliation: Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Sciubba
authors.affiliation: Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Wolinsky
authors.affiliation: Department of Neurosurgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: bydon.mohamad@mayo.edu.
authors.forename: Mohamad
authors.initials: M
authors.lastname: Bydon
authors.affiliation: Department of Neurosurgery, The Warren Alpert Medical School of Brown University, RI 02903, USA.
authors.forename: Ziya
authors.initials: Z
authors.lastname: Gokaslan
mesh_terms: D000328:Adult; D000368:Aged; D055396:Bone Morphogenetic Protein 2 / Q000008:administration & dosage*; D016022:Case-Control Studies; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000639:trends; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011475:Prosthesis Failure / Q000639:trends; D011542:Pseudarthrosis / Q000188:drug therapy* / Q000601:surgery*; D011897:Random Allocation; D011994:Recombinant Proteins / Q000008:administration & dosage; D012086:Reoperation / Q000639:trends; D012189:Retrospective Studies; D013123:Spinal Fusion / Q000009:adverse effects / Q000379:methods; D016212:Transforming Growth Factor beta / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2
keywords: Bone morphogenetic protein; Instrumentation failure; Pseudarthosis; Reoperation