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Spine J. 2017 Dec;17(12):1866-1874. doi: 10.1016/j.spinee.2017.06.023. Epub 2017 Jun 23.

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

Author information

1
Department of Orthopedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
2
Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea. Electronic address: spinelee@snu.ac.kr.
3
Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Sungnam, South Korea.
4
Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
5
Department of Orthopedic Surgery, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, South Korea.
6
Department of Orthopaedic Surgery, School of Medicine, Research Institute of Clinical Medicine of Chonbuk National University Hospital-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, South Korea.
7
Department of Orthopaedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
8
Department of Orthopaedic Surgery, Kangwon National University Hospital, Kangwon National University School of Medicine, Chuncheon, South Korea.
9
Clinical Development Center, Daewoong Pharmaceutical Co., Ltd., Seoul, South Korea.

Abstract

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.

KEYWORDS:

Carrier; Clinical trial; E. coli; Hydroxyapatite; Iliac bone graft; Lumbar; Posterolateral fusion; rhBMP-2

PMID:
28652196
DOI:
10.1016/j.spinee.2017.06.023
[Indexed for MEDLINE]
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