A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: report on safety and feasibility.
METHODS
A prospective, randomized, controlled, multicenter clinical study.


OBJECTIVE
To evaluate the safety and feasibility of osteogenic protein (OP)-1 in 1-level lumbar spine instrumented posterolateral fusions.


BACKGROUND
Instrumented posterolateral fusion with the use of autograft is a commonly performed procedure for a variety of spinal disorders. However, harvesting of bone from the iliac crest is associated with complications. A promising alternative for autograft are bone morphogenetic proteins.


METHODS
As part of a larger prospective, randomized, multicenter study, 36 patients were included, who received a 1-level instrumented posterolateral fusion of the lumbar spine. All patients had a degenerative or isthmic spondylolisthesis with symptoms of neurologic compression. There were 2 treatment arms: OP-1 combined with locally available bone from laminectomy (OP-1 group) or iliac crest autograft (autograft group). The primary outcome was the fusion rate based on a computed tomography scan after 1-year follow-up. The clinical outcome was measured using the Oswestry Disability Index. Additionally, the safety of OP-1 was evaluated by comparing the number and severity of adverse events that occurred between both groups.


RESULTS
Using strict criteria, fusion rates of 63% were found in the OP-1 group and 67% in the control group (P = 0.95). There was a decrease in Oswestry scores at subsequent postoperative time points compared with preoperative values (P > 0.001). There were no significant differences in the mean Oswestry scores between the study group and control group at any time point (P = 0.56). No product-related adverse events occurred.


CONCLUSIONS
The results demonstrate that OP-1 combined with locally obtained autograft is a safe and effective alternative for iliac crest autograft in instrumented single-level posterolateral fusions of the lumbar spine. The main advantage of OP-1 is that it avoids morbidity associated with the harvesting of autogenous bone grafts from the iliac crest.
Delawi
D
D
Department of Orthopaedics, University Medical Center Utrecht, Utrecht, The Netherlands.
Dhert
W J A
WJ
Rillardon
L
L
Gay
E
E
Prestamburgo
D
D
Garcia-Fernandez
C
C
Guerado
E
E
Specchia
N
N
Van Susante
J L C
JL
Verschoor
N
N
van Ufford
H M E Quarles
HM
Oner
F C
FC
D000328:Adult; D000368:Aged; D055419:Bone Morphogenetic Protein 7 / Q000008:administration & dosage* / Q000009:adverse effects*; D016025:Bone Transplantation / Q000009:adverse effects / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000139:chemically induced / Q000209:etiology; D006801:Humans; D007085:Ilium / Q000637:transplantation; D008159:Lumbar Vertebrae / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013123:Spinal Fusion / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D013168:Spondylolisthesis / Q000188:drug therapy / Q000601:surgery; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D055419:Bone Morphogenetic Protein 7