title: Recombinant human BMP-2 increases the incidence and rate of healing in complex ankle arthrodesis.
abstract: BACKGROUND
  Although its FDA-approved applications are limited, the pro-osteogenic benefits of recombinant human BMP-2 (rhBMP-2) administration have been shown in off-label surgical applications. However, the effects of rhBMP-2 on ankle fusions are insufficiently addressed in the literature, which fails to include a case-control study of adequate sample size to evaluate the efficacy of rhBMP-2 treatment.
  
  
  OBJECTIVE
  In this study we asked whether rhBMP-2 treatment (1) would increase the rate of successful ankle fusion in complex patients (patients with comorbidities associated with poor surgical healing) compared with a control group of patients undergoing ankle fusion who did not receive rhBMP-2; (2) would reduce total time wearing a frame when compared with the control group; (3) would result in a difference in the percentage of bone bridging between the group treated with rhBMP-2 and the control group, as determined by CT scans 3 months after surgery; and (4) would encounter an equal rate of complications different from untreated patients.
  
  
  METHODS
  A retrospective chart study was performed on 82 patients who, because of a host of comorbidities associated with poor healing, required a complex ankle arthrodesis with the Ilizarov technique. The first 40 patients did not receive rhBMP-2, whereas the subsequent 42 patients received intraoperative rhBMP-2. Time wearing the frame was determined by chart review; decision to remove the frame was made by the surgeon based on quantitative bone bridging measured using a CT scan taken 3 months after fusion.
  
  
  RESULTS
  Patients treated with rhBMP-2 were more likely to obtain fusion after the initial surgery (93% versus 53%, p < 0.001; OR, 11.76; 95% CI, 3.12-44.41), spent less total time wearing the frame (124 versus 161 days, p < 0.01), and showed more bone bridging on CT scans (48% versus 32%, p < 0.05). All patients with greater than 30% bone bridging observed on CT scans 3 months postoperatively achieved successful union without further intervention.
  
  
  CONCLUSIONS
  Our findings suggest that rhBMP-2 is a beneficial adjunct for selected groups of patients undergoing complex ankle arthrodesis. CT is a promising modality in the assessment of bone healing in ankle fusion. A proper randomized controlled trial remains necessary to fully describe the efficacy of rhBMP-2 in accelerating bone healing.
authors.affiliation: Stony Brook University Medical Center, 19-069 Health Sciences Center, Stony Brook, NY, 11794, USA, Mitchell.Fourman@stonybrookmedicine.edu.
authors.forename: Mitchell S
authors.initials: MS
authors.lastname: Fourman
authors.forename: Eugene W
authors.initials: EW
authors.lastname: Borst
authors.forename: Eric
authors.initials: E
authors.lastname: Bogner
authors.forename: S Robert
authors.initials: SR
authors.lastname: Rozbruch
authors.forename: Austin T
authors.initials: AT
authors.lastname: Fragomen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016512:Ankle Injuries / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D000843:Ankle Joint / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology / Q000601:surgery*; D001174:Arthrodesis / Q000009:adverse effects; D055396:Bone Morphogenetic Protein 2 / Q000627:therapeutic use*; D016267:External Fixators; D005260:Female; D017102:Fracture Healing / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010012:Osteogenesis / Q000187:drug effects*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins