Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine

Independent, retrospective clinical record review with a concurrent control. To identify whether rhBMP-2 is associated with an increased incidence of clinically relevant postoperative prevertebral swelling problems in patients undergoing anterior cervical fusions. Bone Morphogenetic Protein-2 (rhBMP...

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Bibliographic Details
Published in:Spine (Philadelphia, PA. 1976) PA. 1976), 2006-11, Vol.31 (24), p.2813-2819
Main Authors: SMUCKER, Joseph D, RHEE, John M, SINGH, Kern, YOON, S. Tim, HELLER, John G
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Biological and medical sciences
Bone Morphogenetic Protein 2
Bone Morphogenetic Proteins - adverse effects
Bone Morphogenetic Proteins - therapeutic use
Cerebrospinal fluid. Meninges. Spinal cord
Cervical Vertebrae - surgery
Child
Deglutition Disorders - epidemiology
Deglutition Disorders - etiology
Diseases of the osteoarticular system
Diseases of the spine
Edema - chemically induced
Edema - epidemiology
Female
Humans
Incidence
Male
Medical sciences
Middle Aged
Neck
Nervous system (semeiology, syndromes)
Neurology
Orthopedic surgery
Postoperative Complications - chemically induced
Postoperative Complications - epidemiology
Recombinant Proteins - administration & dosage
Recombinant Proteins - therapeutic use
Spinal Fusion
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Transforming Growth Factor beta - adverse effects
Transforming Growth Factor beta - therapeutic use
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Summary:Independent, retrospective clinical record review with a concurrent control. To identify whether rhBMP-2 is associated with an increased incidence of clinically relevant postoperative prevertebral swelling problems in patients undergoing anterior cervical fusions. 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. 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. 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. Off-label use of rhBMP-2 in the anterior cervical spine is associated with an increased rate of clinically relevant swelling events.
ISSN:0362-2436
1528-1159
DOI:10.1097/01.brs.0000245863.52371.c2