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Evaluation of the Fusion Rate and Safety of Escherichia coli-Derived rhBMP-2 in Transforaminal Lumbar Interbody Fusion for Patients with Degenerative Lumbar Disease: A Prospective, Multicenter, Single-Arm Trial – Lumbar Fusion

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This article reports on a study that assessed the safety and efficacy of using E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). The study, which included 30 patients, found that all instances showed fusion outcomes at 52 and 104 weeks post-surgery, with significant improvements in clinical outcomes. There were no perioperative adverse events requiring reoperation, and no incidences of postoperative complications such as seroma, radiculitis, or cage migration. The study demonstrates the high safety and efficacy of using E. coli-derived rhBMP-2 in TLIF, with promising results in bone fusion

Summarised by Mr Mo Akmal – Lead Spinal Surgeon
The London Spine Unit : the highest rated spinal centre on Harley Street UK

Published article

Background: Few studies have documented the viability of E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). This study aimed to assess the safety and fusion rate of rhBMP-2 in TLIF. Methods: The study was conducted as a prospective, multicenter, single-arm trial, and 30 patients needing one- or two-level TLIF were enrolled. Fusion rate was assessed using the 12-month interbody fusion rate on CT. Postoperative problems,…

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J Clin Med. 2024 Mar 17;13(6):1733. doi: 10.3390/jcm13061733.ABSTRACTBackground: Few studies have documented the viability of E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). This study aimed to assess the safety and fusion rate of rhBMP-2 in TLIF. Methods: The study was conducted as a prospective, multicenter, single-arm trial, and,

J Clin Med. 2024 Mar 17;13(6):1733. doi: 10.3390/jcm13061733.

ABSTRACT

Background: Few studies have documented the viability of E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). This study aimed to assess the safety and fusion rate of rhBMP-2 in TLIF. Methods: The study was conducted as a prospective, multicenter, single-arm trial, and 30 patients needing one- or two-level TLIF were enrolled. Fusion rate was assessed using the 12-month interbody fusion rate on CT. Postoperative problems, including seroma, radiculitis, and ectopic bone formation, which have been documented as risks associated with rhBMP-2 in prior studies, were recorded. Results: The study demonstrated fusion outcomes in all instances at 52 and 104 weeks post-surgery. Significant improvements were observed in clinical outcomes, with ODI, SF-36, and VAS scores, all achieving statistical significance (p < 0.0001). No perioperative adverse events requiring reoperation were reported, and there were no incidences of seroma, radiculitis, cage migration, grafted bone extrusion, postoperative neurologic deficit, or deep wound infection. s: The study demonstrates the high safety and efficacy in inducing bone fusion of E. coli-derived rhBMP-2 in TLIF, with a notable absence of adverse postoperative complications. Trial registration: This study protocol was registered at Korea Clinical Research Information Service (number identifier: KCT0004738) on July 2020.

PMID:38541958 | DOI:10.3390/jcm13061733

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Evaluation of the Fusion Rate and Safety of Escherichia coli-Derived rhBMP-2 in Transforaminal Lumbar Interbody Fusion for Patients with Degenerative Lumbar Disease: A Prospective, Multicenter, Single-Arm Trial

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J Clin Med. 2024 Mar 17;13(6):1733. doi: 10.3390/jcm13061733.ABSTRACTBackground: Few studies have documented the viability of E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). This study aimed to assess the safety and fusion rate of rhBMP-2 in TLIF. Methods: The study was conducted as a prospective, multicenter, single-arm trial, and

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