Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine.
METHODS
Independent, retrospective clinical record review with a concurrent control.


OBJECTIVE
To identify whether rhBMP-2 is associated with an increased incidence of clinically relevant postoperative prevertebral swelling problems in patients undergoing anterior cervical fusions.


BACKGROUND
Bone Morphogenetic Protein-2 (rhBMP-2) is FDA approved as a bone graft substitute in anterior lumbar interbody fusions. rhBMP-2 has also been used "off-label" in anterior cervical fusions. We suspected that rhBMP-2 might increase the incidence of adverse swelling events.


METHODS
A total of 234 consecutive patients (ages 12-82 years) undergoing anterior cervical fusion with and without rhBMP-2 over a 2-year period at one institution comprised the study population. The incidence of clinically relevant prevertebral swelling was calculated. The populations were compared and statistical significance was determined.


RESULTS
A total of 234 patients met the study criteria, 69 of whom underwent anterior cervical spine fusions using rhBMP-2; 27.5% of those patients in the rhBMP-2 group had a clinically significant swelling event versus only 3.6% of patients in the non-rhBMP-2 group. This difference was statistically significant (P < 0.0001) and remained so after controlling for other significant predictors of swelling.


CONCLUSIONS
Off-label use of rhBMP-2 in the anterior cervical spine is associated with an increased rate of clinically relevant swelling events.
Smucker
Joseph D
JD
Department of Orthopaedic Surgery, University of Iowa, Iowa City, IA, USA.
Rhee
John M
JM
Singh
Kern
K
Yoon
S Tim
ST
Heller
John G
JG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000009:adverse effects* / Q000627:therapeutic use; D002574:Cervical Vertebrae / Q000601:surgery*; D002648:Child; D003680:Deglutition Disorders / Q000453:epidemiology / Q000209:etiology; D004487:Edema / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009333:Neck; D011183:Postoperative Complications / Q000139:chemically induced* / Q000453:epidemiology; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D013123:Spinal Fusion; D016212:Transforming Growth Factor beta / Q000009:adverse effects* / Q000627:therapeutic use
C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta