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Efficacy of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in posterolateral lumbar fusion: an open, active-controlled, randomized, multicenter trial

 Jae Hwan Cho  ;  Jae Hyup Lee  ;  Jin Sup Yeom  ;  Bong-Soon Chang  ;  Jae Jun Yang  ;  Ki Hyoung Koo  ;  Chang Ju Hwang  ;  Kwang Bok Lee  ;  Ho-Joong Kim  ;  Choon-Ki Lee  ;  Hyoungmin Kim  ;  Kyung-Soo Suk  ;  Woo Dong Nam  ;  Jumi Han 
 SPINE JOURNAL, Vol.17(12) : 1866-1874, 2017 
Journal Title
Issue Date
Aged ; Bone Morphogenetic Protein 2/administration & dosage ; Bone Morphogenetic Protein 2/adverse effects ; Bone Morphogenetic Protein 2/therapeutic use* ; Bone Substitutes/administration & dosage ; Bone Substitutes/adverse effects* ; Bone Substitutes/chemistry ; Bone Substitutes/therapeutic use ; Bone Transplantation/adverse effects ; Bone Transplantation/methods* ; Durapatite/administration & dosage ; Durapatite/adverse effects ; Durapatite/therapeutic use ; Female ; Humans ; Ilium/transplantation ; Male ; Middle Aged ; Spinal Fusion/adverse effects ; Spinal Fusion/methods* ; Treatment Outcome
Carrier ; Clinical trial ; E. coli ; Hydroxyapatite ; Iliac bone graft ; Lumbar ; Posterolateral fusion ; rhBMP-2
BACKGROUND CONTEXT: The efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) as a bone graft substitute in spinal fusion has been widely researched. However, no study of the efficacy and safety of Escherichia coli-derived rhBMP-2 (E.BMP-2) with a hydroxyapatite (HA) carrier has been proposed.

PURPOSE: This study aimed to compare the efficacy and safety of fusion materials between E.BMP-2 and autogenous iliac bone graft in posterolateral fusion (PLF).

STUDY DESIGN/SETTING: An open, active-controlled, randomized, multicenter trial was carried out.

PATIENT SAMPLE: This study included 93 patients who underwent single-level lumbar or lumbosacral PLF.

OUTCOME MEASURES: The primary outcome measure was computed tomography (CT)-based fusion rate at 12 and 24 weeks. Secondary outcome measures were fusion grade by radiographs and CT at 12 and 24 weeks and changes in Oswestry Disability Index (ODI), Short Form-36 (SF-36) Health Survey, and visual analogue scale (VAS).

METHODS: Patients who underwent 1-level PLF (between L1 and S1) for severe spinal stenosis or grade 1 spondylolisthesis were randomized to receive E.BMP-2 with an HA carrier (E.BMP-2 group) or autogenous iliac bone graft (AIBG group). Thin-section CT (<2 mm), VAS, ODI, and SF-36 were obtained pre- and postoperatively at 12 and 24 weeks. Outcome measures were compared between the groups.

RESULTS: A total of 100 patients were enrolled in this trial. Among them, 93 patients underwent planned surgery. Preoperative demographic and clinical data showed no difference between groups. CT-based fusion rates were 100.0% (41/41) for the E.BMP-2 group and 90.2% (46/51) for the AIBG group (p=.062) at 12 weeks and 100.0% (41/41) and 94.1% (48/51) (p=.251) at 24 weeks, respectively. Fusion grade based on radiographs and CT showed non-inferiority of the E.BMP-2 group compared with the AIBG group. All clinical parameters improved postoperatively. However, there was no difference in changes in VAS, ODI, or SF-36 between the groups. No serious adverse event related to E.BMP-2 was found.

CONCLUSIONS: The fusion rate of E.BMP-2 was comparable with that of AIBG following PLF. Good clinical efficacy and safety of E.BMP-2 in spinal fusion were also revealed. It was also suggested that HA shows suitability as a carrier for E.BMP-2. Thus, E.BMP-2 with an HA carrier can be an alternative bone graft material in spinal fusion.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Suk, Kyung Soo(석경수) ORCID logo https://orcid.org/0000-0003-0633-2658
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