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Prospective Randomized Study of Posterolateral Lumbar Fusion (printer-friendly)
www.meds
uthors and Disclosures
hi-Chien Niu, MD, Tsung-Ting Tsai, MD, Tsai-Sheng Fu, MD, Po-Liang Lai, MD, Lih-Huei Chen, MD, and We
r Chen, MD
epartment of Orthopaedic Surgery, Chang Gung Memorial Hospital, Chang Gung University College of Medicine
hang Gung Institute of Technology, Taoyuan, Taiwan.
ddress correspondence and reprint requests to
en-Jer Chen, MD, Department of Orthopaedic Surgery, Chang Gung Memorial Hospital, 5, Fu-Hsing St, Kweisha
oyuan 333, Taiwan; E-mail: [email protected]
rom Spine
A Comparison of Posterolateral Lumbar Fusion ComparingAutograft, Autogenous Laminectomy Bone w ith BoneMarrow Aspirate, and Calcium Sulphate with Bone MarrowAspirate: A P rospective Random ized StudyMA and Autograft, Autogenous Laminectomy Bone or Calcium Sulphate
hi-Chien Niu, MD; Tsung-Ting Tsai, MD; Tsai-Sheng Fu, MD; Po-Liang Lai, MD; Lih-Huei Chen, MD; Wen-Jer Chen, M
osted: 03/09/2010; Spine. 2009;34(25):2715-9. © 2009 Lippincott Williams & Wilkins
bstract and Introduction
bstract
udy Design. A prospective clinical study.
bjective. To evaluate whether the fusion rate of autogenous laminectomy bone chips and calcium sulfate pellets
uld be augmented by bone marrow aspirate (BMA) in one-level lumbar posterolateral fusion.
ummary of Background Data. An in vivo animal study has indicated that BMA augments spinal arthrodesis.
ethods. Forty-three patients undergoing surgery for instrumented one-level fusion with decompression were divi
o 2 groups. Autologous iliac crest bone graft (ICBG) was placed in 1 posterolateral gutter (control), while on the
de (test), an equal quantity of laminectomy bone chips mixed with BMA while harvesting the iliac bone graft (grou
an equal quantity of calcium sulfate pellets soaked in BMA (group 2) was placed. Radiographic assessment was
rformed every 3 months (3 –12 months) and then annually. The statuses of fusion on either side of the vertebra w
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Prospective Randomized Study of Posterolateral Lumbar Fusion (printer-friendly)
aterials and Methods
e study was carried out with the approval of the Institutional Review Board of our hospital. From August 2003 to
04, 43 consecutive patients with lumbar spinal stenosis and one-level low-grade degenerative or spondylolytic
ondylolisthesis (grade I or II) or segmental instability prospectively underwent decompression and pedicle screw
strumented posterolateral fusions. The exclusion criteria for all patients included a history of previous lumbar spin
rgery, spinal infection, systemic autoimmune inflammatory disease, end-stage renal disease, and high-grade
ondylolisthesis. The patients were divided into 2 groups: the first 21 patients were group I and the subsequent 22
tients were group II. For both groups, 10 mL of autogenous iliac cancellous bone graft was placed in 1 side of
sterolateral gutter as the control side. On the other side as the test side, an equivalent amount (10 mL) of ALB c
ere soaked in BMA for group I, whereas Osteoset pellets were mixed with BMA in group II.
urgical Techniques
ecompressive laminectomy was performed to remove the spinal process and lamina in the region of spinal canal
enosis. The ALB chips that were extracted during laminectomy were morselized and were collected by meticulou
moving the covering soft tissue; this morselized bone chips was used as a graft on the test side in group I.
tologous cancellous bone (10 mL) was harvested from the posterior iliac crest by opening an approximately 3 ×
m window at the outer cortex, and this was grafted on the control side for both groups. While harvesting, 10 mL of
ne marrow was aspirated with a syringe from the ilium. The BMA was then mixed with the morselized laminecto
LB chips or CS (Osteoset) pellets for group 1 and 2, respectively. After placing the transpedicular screw/rod
strumentation at the target levels, the autologous iliac cancellous bone graft was placed on the control side (left s
this study). Then, on the test side (right side), laminectomy ALB chips (group I) and CS pellets (group II) that mix
th BMA were placed.
utcomes
nly fusion status was evaluated and recorded in this study. After surgery, fusion was radiographically assessed e
months during the first year and subsequently on an annual basis; computerized tomography scans were perform
least 1 year after the surgery. The radiographic analysis of the fusion status was performed by 2 independent sp
rgeons who were blinded to the test and control sides of the patients. A successful fusion was determined when
rgeons found radiographic evidences of fusion, and a solid fusion was defined as continuous intertransverse bon
dging at the target level on the follow-up radiographs (Figure 1) and/or computerized tomography scans (Figure
e fusion results of both sides were recorded separately for intergroup comparison; the data were compared
atistically using McNemar's χ2 test with a P value of <0.05 was considered statistically significant.
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Figure 1. A 27-year-old man received the posterolateral fusion and instrumentation at L5 –S1 for spondylolytic
spondylolisthesis. The immediately postoperative anteroposterior (AP) view (A) showed a mixture of local bone
chips and bone marrow aspirate (BMA) was used at the patients right side and the autologous iliac bone graft
was used at the left side. B, Significant bone bridging between transverse processes on bilateral sides was
showed in the 3-month AP view.
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Figure 2. The computer-tomogram reconstruction scan of lumbosacral spine was checked 1 or 2 years after
operation for the better identification of successful fusion between the transverse processes.
esults
oup I comprised 21 patients (7 males and 14 females) with an average age of 58 years (range, 27 –75 years). Th
tients with degenerative spondylolisthesis, spondylolytic spondylolisthesis, and segmental instability were numbe
, 5, and 1, respectively. Within group I, there is 1 patient with fusion level at L3 –L4, 16 patients with fusion level
–L5, and 4 patients with fusion level at L4 –L5. Group II comprised 22 patients (9 males and 13 females) with an
erage age of 59 years (range, 41 –72 years). The patients with degenerative spondylolisthesis, spondylolytic
ondylolisthesis, and segmental instability were numbered 17, 4, and 1, respectively. There is 1 patient with fusio
vel at L3-L4, 18 patients with fusion level at L4 –L5 and 3 patients with fusion level at L4 –L5. Smokers were equa
stributed in both groups (4/21 in group I and 5/22 in group II). The overall demographic data of both groups were
milar. All patients in group I and II had follow-up after surgery with an average of 24.6 months (range, 24 –29 mon
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d 24.1 month (range, 24 –27 months), respectively.
group I, 19 of 21 (90.5%) patients were observed to achieve solid bone fusion on the control side and 18 of 21
5.7%) patients achieved it on the test side (Figure 1), which indicates that there was no statistical difference in fu
es between both sides (P = 0.56).
group II, 20 of 22 (90.9%) patients were observed to achieve solid bone fusion on the control side, but only 10 o
0.5%) patient achieved it on the test side (Figure 3). As a result, there was a statistically significant difference in
sion rates between the control and test sides (P = 0.0016).
Figure 3. A 46-year-old woman received the posterolateral fusion and pedicle screw fixation at L4 –L5 for
degenerative spondylolisthesis. The immediately postoperative AP view (A) showed the mixture of Osteoset an
BMA was used at the patients right side and the autologous iliac bone graft was used at the patients left side.
The postoperative 1-year AP view (B) showed a significant bone bridging on the patients left side but no bone
bridging on the patients right side.
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scussion
e ideal bone graft substitute for spinal fusion should possess both osteoconductivity and osteoinductivity; moreo
e presence of osteogenetic cells is an added advantage of achieving a superior fusion rate that is equivalent to th
c bone graft. The grafts that primarily offer the property of osteoconductive are ceramic products such as
droxyapatite, calcium phosphate or sulfate, and freeze-dried allografts, which provide scaffolding that facilitate
teogenesis. In addition, the rhBMP and demineralized bone matrix products are the graft substitutes or expandeth osteoinductive character that also facilitate osteogenesis. That is to say, autologous iliac cancellous bone graf
ntains 3 critical elements of enhanced osteogenesis: trabeculae of bone which is acted as osteoconductive scaff
atrix of BMPs as osteoinductive factors, and osteoblasts as osteogenetic cells. Since it possesses all the
aracteristics required for an ideal bone graft, it is termed as the gold standard for grafts. However, bone graft
rvesting at the donor site can easily lead to significant morbidity[21 –24] and the material is relatively limited in
ailability.
onnolly et al [25] clinically found the osteopromotive effects of whole bone marrow when autologous marrow was
ected into a tibial defect site. Although both blood and bone marrow could be immediately harvested and used a
tologous materials for osteopromotion, an in vivo animal study[19] proved that BMA has a higher osteogenic pote
an blood when it is impregnated through β-tricalcium phosphate (β-TCP), an osteoconductive scaffold. The reaso
this difference could be the presence of osteoprogenitor cells or bone marrow stem cells in BMA. Furthermore,
me study showed that the osteopromotive effect of BMA was also higher than concentrated mononuclear cells. T
ck of fibrin clot in which the cells can attach and migrate in the concentrated cell suspension may be the reason f
other adjuvant factor could be the osteoinductive factors that were presented in BMA, were absented in the
ncentrated cell group.
an adjuvant to porous calcium phosphate, TCP, and hydroxyapatite ceramics (osteoconductive grafts), marrow
ve been proved to be successful in enhancing osteogenesis in rats and sheep.[19,26,27] Even the beneficial effec
teogenesis of xenograft bone with autologous red marrow implanted in paravertebral muscle, an open system, h
so evidenced in a rat study.[28] These studies suggested that autologous bone marrow greatly facilitates
teopromotion in combination with grafts that are strongly osteoconductive or weakly osteoinductive in nature. Thesence of osteoprogenitor cells and osteoinductive factors in BMA is the critical reason for such enhanced effect
ese key factors are also present in the iliac crest autograft—the gold standard of bone grafting and play the
portant role of facilitating osteogenesis.
cording to the study by Muschler et al ,[18] enriched cancellous bone matrix plus bone marrow clot composite gra
at contain increased amount of marrow-derived osteogenic cells showed improvement in bone grafting. Despite l
ncentration of osteogenic cells in BMA, bone marrow clot could still provide a stabilized environment by serving
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affold in which the cells and factors could attach and migrate along with some osteotropic cytokines, growth facto
d additional angiogenic factors from the fibriolytic activity that occurred during the first several days within a clot.
ese characteristics of the adjuvant BMA play an important role in the process of successful bone healing.
hough bone marrow facilitates osteogenesis, only 43% of cases achieved successful bone formation when only
arrow autograft was transplanted into Wistar rats.[29] The explanation of this low success rate could be the absen
a proper scaffold which cause the soft marrow from the squeezing action of the muscles and poor maintenance
e marrow cells at the implantation site to reduce protection. Consequently, bone marrow graft is superior when it
ade as a composite graft due to the presence of osteoinductive factors in the marrow and the scaffold support
ovided by some solid osteoconductive grafts. Porous or trabecular scaffolding grafts are considered to be of a
perior quality.
e bone chips extracted during laminectomy are mainly cortical in nature. Trabecular bone and unmineralized ma
e main components of the marrow cavity, only comprise a small percentage of the posterior elements in the spina
ucture, including lamina, facet joints and spinal processes, which are the components that are resected during
minectomy. If these bone chips are used as a graft substitute for intertransverse fusion of the lumbar spine, the re
ay be theoretically inferior to the gold standard, posterior iliac cancellous bone graft, due to reduced osteoinducti
tivity. In this study, the osteoinductivity was augmented by impregnating the bone chips with BMA; additionally, t
od scaffolding of marrow was provided by the potential space presented in these bone chips, and fibrin clot from
MA could also provide an additional holding effect for all the chips, cells and matrix. Thus, in group I, the fusion ra
s graft was equivalent to that seen on the contralateral side (P > 0.05).
e ceramic bone graft substitute—Osteoset—is a composite of CS. According to an in vivo animal study,[30] CS
owed rapid resorption of CS pellet within 1 and 3 weeks, followed by major bone apposition at 3 and 6 weeks. In
udy, bony repair was still in progress up to week 12; however, the quality and quantity of the newly formed bone
gnificantly influenced by the occupied avascular fibrous tissue. Because of its early resorption, the scaffolding of
arrow as a discrete mass would be lost and left empty at the early stage. This interference might be more signific
ntertransverse fusion of the lumbar spine because it is an open system. The inferior osteogenetic result of CS w
ne marrow in this group was presumed to be due to the fact that early resorption had caused the loss of the
teoconductive property of Osteoset at the early stage and the osteoinductive effect offered by the BMA could no
aintained in an open system. Furthermore, Osteoset pellets are cylindrical and smooth-surfaced, and the effect o
alloping to keep marrow is certainly worse than the porous ceramics or the bone chips from laminectomy. Porou
d granular formed ceramics, such as calcium phosphate products, have longer survival time and ought to
gnificantly improve fusion when they are mixed with BMA; this will be the topic of a subsequent study.
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adjunct to iliac crest autograft in posterolateral lumbar fusions. Euro Spine J 2003;12:495 –500.
15. Vaccaro AR, Patel T, Fischgrund J, et al. A 2-year follow-up pilot study evaluating the safety and efficacy o
OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions. Euro Spine J
2005;14:623 –9.
16. Tay BK, Le AX, Heilman M, et al. Use of a collagen-hydroxyapatite matrix in spinal fusion. A rabbit model.
Spine 1998;23:2276 –81.
17. Muschler GF, Boehm C, Easley K. Aspiration to obtain osteoblast progenitor cells from human bone marro
the influence of aspiration volume. J Bone Joint Surg Am 1997;79:1699 –709.
18. Muschler GF, Nitto H, Matsukura Y, et al. Spine fusion using cell matrix composites enriched in bone marr
derived cells. Clin Orthop 2003;407:102 –18.
19. Becker S, Maissen O, Ponomarev I, et al. Osteopromotion by a β-tricalcium phosphate/bone marrow hybri
implant for use in spine surgery. Spine 2006;31:11 –7.
20. Nade S, Burwell RG. Decalcified bone as a substrate for osteogenesis. An appraisal of the interrelation of
and marrow in combined grafts. J Bone Joint Surg Br 1977;59:189 –96.
21. Laurie SW, Kaban LB, Mulliken JB, et al. Donor-site morbidity after harvesting rib and iliac bone. Plast
Reconstr Surg 1984;73:933 –8.
22. Summers BN, Eisenstein SM. Donor site pain from the ilium. A complication of lumbar spine fusion. J Bone
Joint Surg Br 1989;71:677 –80.
23. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma 1989;3:192 –5.
24. Fernyhough JC, Schimandle JJ, Weigel MC, et al. Chronic donor site pain complicating bone graft harvest
from the posterior iliac crest for spinal fusion. Spine 1992;17:1474 –80.
25. Connolly JF, Guse R, Tiedeman J, et al. marrow injection as a substitute for operative grafting of tibial
nonunions. Clin Orthop 1991;266:259 –70.
26. Ohgushi H, Goldberg VM, Caplan AI. Repair of bone defects with marrow cells and porous ceramic.
Experiments in rats. Acta Orthop Scand 1989;60:334 –9.
27. Ohgushi H, Okumura M, Tamai S, et al. Marrow cell induced osteogenesis in porous hydroxyapatite and
tricalcium phosphate: a comparative histomorphometric study of ectopic bone formation. J Biomed Mater R
1990;24:1563 –70.
28. Salama R, Burwell RD, Dickson IR. Recombined grafts of bone and marrow. The beneficial effect upon
osteogenesis of impregnating xenograft (heterograft) bone with autologous red marrow. J Bone Joint Surg
1973;55:402 –17.
29. Burwell RG. Studies in the transplantation of bone. VII. The fresh composite homograft-autograft of cancel
bone; an analysis of factors leading to osteogenesis in marrow transplants and in marrow-containing bone
grafts. J Bone Joint Surg Br 1964;46:110 –40.
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30. Hing KA, Wilson LF, Buckland T. Comparative performance of three ceramic bone substitutes. Spine J No
Am 2007;7:475 –90.
he manuscript submitted does not contain information about medical device(s)/drug(s).
o funds were received in support of this work. No benefits in any form have been or will be received from a commercial party relatedrectly or indirectly to the subject of this manuscript.
pine. 2009;34(25):2715-9. © 2009 Lippincott Williams & Wilkins