Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion.
METHODS
Prospective, randomized, unblinded study of iliac crest bone graft (ICBG) versus recombinant human bone morphogenetic protein-2/compression resistant matrix (rhBMP-2/CRM)in a posterolateral instrumented fusion procedure.


OBJECTIVE
Document initial radiographic characteristics, based on computed tomography, with rhBMP-2/CRM for posterolateral fusion at 6 and 12-month intervals.


BACKGROUND
As the acceptance of INFUSE bone graft as an ICBG replacement becomes more widespread, surgeons have begun to study applications for rhBMP-2 in posterior spinal fusion. Preclinical studies have examined variables including carrier composition, rhBMP-2 concentration, and rhBMP-2 dose. Pilot studies have been performed with encouraging initial results.


METHODS
Patients with single level lumbar degenerative disease were enrolled in a randomized study of ICBG versus rhBMP-2/CRM in a posterolateral instrumented fusion procedure. Computed tomography scans at 6 and 12 months were graded as demonstrating no fusion (grade 1), partial or limited unilateral fusion (grade 2), partial or limited bilateral fusion (grade 3), solid unilateral fusion (grade 4), or solid bilateral fusion (grade 5).


RESULTS
At our institution, 74 patients (38 rhBMP-2/CRM, 36 ICBG) reached minimum 1-year follow-up and were included in this analysis. Mean fusion grade (scale1-5) at 6 months after surgery was 4.35 in the rhBMP-2/CRM group versus 3.09 in the ICBG group (P < 0.0001). At 1 year after surgery mean fusion grade was 4.62 in the rhBMP-2/CRM group versus 3.77 in the ICBG group (P < 0.0023).


CONCLUSIONS
These early results are encouraging and suggest a more rapid incorporation and development of the fusion mass with rhBMP-2/CRM than iliac crest autograft in a single level posterior instrumented fusion.
Glassman
Steven D
SD
Department of Orthopaedic Surgery, University of Louisville School of Medicine, The Kenton D. Leatherman Spine Center, Louisville, Kentucky, USA. tallgeyer@spinemds.com
Dimar
John R
JR
Carreon
Leah Y
LY
Campbell
Mitchell J
MJ
Puno
Rolando M
RM
Johnson
John R
JR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000008:administration & dosage*; D016025:Bone Transplantation / Q000379:methods; D002130:Calcium Phosphates / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage*; D004337:Drug Carriers / Q000008:administration & dosage*; D017886:Durapatite / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D012907:Smoking / Q000009:adverse effects; D013122:Spinal Diseases / Q000188:drug therapy / Q000601:surgery; D013123:Spinal Fusion / Q000379:methods*; D018709:Statistics, Nonparametric; D016212:Transforming Growth Factor beta / Q000008:administration & dosage*
C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D002130:Calcium Phosphates; D004337:Drug Carriers; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; D003094:Collagen; D017886:Durapatite; C018392:tricalcium phosphate