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URL
https://doi.org/10.26502/josm.511500060
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Title
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A Pre-clinical Standard Operating Procedure for Evaluating Orthobiologics in an In Vivo Rat Spinal Fusion Model
Creator
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Andrew L Alejo
Scott McDermott
Yusuf Khalil
Hope C Ball
Gabrielle T Robinson
Ernesto Solorzano
Amanda M Alejo
Jacob Douglas
Trinity K Samson
Jesse W Young
Fayez F Safadi
Date
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2022
Description
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The rat animal model is a cost effective and reliable model used in spinal pre-clinical research. Complications from various surgical procedures in humans often arise that were based on these pre-clinical animal models. Therefore safe and efficacious pre-clinical animal models are needed to establish continuity into clinical trials. A Standard Operating Procedure (SOP) is a validated method that allows researchers to safely and carefully replicate previously successful surgical techniques. Thus, the aim of this study is to describe in detail the procedures involved in a common rat bilateral posterolateral intertransverse spinal fusion SOP used to test the efficacy and safety different orthobiologics using a collagen-soaked sponge as an orthobiologic carrier. Only two orthobiologics are currently FDA approved for spinal fusion surgery which include recombinant bone morphogenetic protein 2 (rhBMP-2), and I-FACTOR. While there are many additional orthobiologics currently being tested, one way to show their safety profile and gain FDA approval, is to use well established pre-clinical animal models. A preoperative, intraoperative, and postoperative surgical setup including specific anesthesia and euthanasia protocols are outlined. Furthermore, we describe different postoperative methods used to validate the spinal fusion SOP, which include μCT analysis, histopathology, biomechanical testing, and blood analysis. This SOP can help increase validity, transparency, efficacy, and reproducibly in future rat spinal fusion surgery procedures.
Source
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J Orthop Sports Med
. 2022;4(3):224-240. doi: 10.26502/josm.511500060. Epub 2022 Sep 5.
Language
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English
2022
Orthobiologics
Posterolateral intertransverse fusion model
Protocols
rat model
rhBMP-2
Spinal Fusion
Standard Operating Procedure (SOP)
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n/a
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Pages
256-271
Issue
2
Volume
60
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Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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Assessment of outcome following the use of recombinant human bone morphogenetic protein-2 for spinal fusion in the elderly population
Publisher
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Journal of Neurosurgical Sciences
Date
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2016
2016-06
Subject
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Allografts; anterior cervical-spine; Bone morphogenetic protein-2; clinical article; ectopic bone; Elderly; graft; lumbar interbody fusion; Neurosciences & Neurology; off-label use; older-adults; Outcome Assessment (Health Care); perioperative complications; rhBMP-2; rhBMP-2; Spinal fusion; Spine surgery; Surgery; Surgery
Creator
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Shweikeh F; Hanna G; Bloom L; Sayegh E T; Liu J; Acosta F L; Drazin D
Description
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INTRODUCTION: Although the use of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion has been fairly studied in the general population, relatively little research has been conducted on its use in the elderly patient demographic despite this population's growth. The authors sought to examine the clinical efficacy, complication rate, and cost-effectiveness of rhBMP-2 use in elderly patients undergoing spinal fusion surgery. EVIDENCE ACQUISITION: We conducted a systematic review of the published literature for elderly patients that underwent spinal fusion surgery with the use of rhBMP-2. A systematic search was performed utilizing the PUBMED and MEDLINE databases in order to identify all papers dealing with recombinant human Bone Morphogenic Protein-2 use in patients over the age of 60 years. EVIDENCE SYNTHESIS: Twenty-five papers were identified that met our inclusion criteria. While successful fusion, improvement in pain, and improved quality of life were encountered in elderly patients who were treated with fusions surgery along with rhBMP-2, there were several complications that were encountered including seroma formation, pleural effusions, and bone non-union. CONCLUSIONS: The literature demonstrated that BMP serves as a potent osteoinductive agent in the elderly with similar efficacy to bone auto graft. Although use of BMP showed mixed results and had higher initial costs, when taken into account with complication correction and costs, BMP usage appears to be more economically beneficial overall. Future studies are needed to clarify the clinical significance of the complications encountered in elderly patients treated with rhBMP-2. Future research can assist in developing recommendations which can minimize these risks in the elderly patient demographic.
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n/a
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Journal Article
2016
Acosta F L
Allografts
anterior cervical-spine
Bloom L
Bone morphogenetic protein-2
clinical article
Drazin D
ectopic bone
Elderly
graft
Hanna G
Journal Article
Journal of Neurosurgical Sciences
Liu J
lumbar interbody fusion
Neurosciences & Neurology
off-label use
older-adults
Outcome Assessment (Health Care)
perioperative complications
rhBMP-2
Sayegh E T
Shweikeh F
Spinal Fusion
spine surgery
Surgery