Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion

Shinji Takahashi; Zorica Buser; Jeremiah R. Cohen; Allison Roe; Sue L. Myhre; Hans Joerg Meisel; Darrel S. Brodke; S. Tim Yoon; Jong Beom Park; Jeffrey C. Wang; Jim A. Youssef

doi:10.1097/BSD.0000000000000443

Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion

Shinji Takahashi, Zorica Buser, Jeremiah R. Cohen, Allison Roe, Sue L. Myhre, Hans Joerg Meisel, Darrel S. Brodke, S. Tim Yoon, Jong Beom Park, Jeffrey C. Wang, Jim A. Youssef

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Study Design: A retrospective cohort study. Objective: To compare the complications between posterior cervical fusions with and without recombinant human bone morphogenetic protein 2 (rhBMP2). Summary of Background Data: Use of rhBMP2 in anterior cervical spinal fusion procedures can lead to potential complications such as neck edema, resulting in airway complications or neurological compression. However, there are no data on the complications associated with the "off-label" use of rhBMP2 in upper and lower posterior cervical fusion approaches. Materials and Methods: Patients from the PearlDiver database who had a posterior cervical fusion between 2005 and 2011 were identified. We evaluated complications within 90 days after fusion and data was divided in 2 groups: (1) posterior cervical fusion including upper cervical spine O-C2 (upper group) and (2) posterior cervical fusion including lower cervical spine C3-C7 (lower group). Complications were divided into: any complication, neck-related complications, wound-related complications, and other complications. Results: Of the 352 patients in the upper group, 73 patients (20.7%) received rhBMP2, and 279 patients (79.3%) did not. Likewise, in the lower group of 2372 patients, 378 patients (15.9%) had surgery with rhBMP2 and 1994 patients (84.1%) without. In the upper group, complications were observed in 7 patients (9.6%) with and 34 patients (12%) without rhBMP2. In the lower group, complications were observed in 42 patients (11%) with and 276 patients (14%) without rhBMP2. Furthermore, in the lower group the wound-related complications were significantly higher in the rhBMP2 group (23 patients, 6.1%) compared with the non-rhBMP2 group (75 patients, 3.8%). Conclusions: Our data showed that the use of rhBMP2 does not increase the risk of complications in upper cervical spine fusion procedures. However, in the lower cervical spine, rhBMP2 may elevate the risk of wound-related complications. Overall, there were no major complications associated with the use of rhBMP2 for posterior cervical fusion approaches. Level of Evidence: Level III.

Original language	English
Pages (from-to)	E1269-E1273
Journal	Clinical Spine Surgery
Volume	30
Issue number	9
DOIs	https://doi.org/10.1097/BSD.0000000000000443
State	Published - 2017

Bibliographical note

Funding Information:
Z.B.: Xenco Medical (consultancy); J.R.C.: AOSpine (paid to acquire data); H.J.M.: consultancy (money paid to institution): Zyga, DiFusion, Regenerate Life Sciences GmbH (past); royalties: Aesculap (past), Medtronic, Fehling; stock/stock options (money paid to institution): DiFusion, Regenerate Life Sciences GmbH (past); D.S.B.: royalties: Amedica, DePuy Synthes, Medtronic; stock ownership: Amedica; consulting: Amedica, Vallum and DePuy Synthes; fellowship support: AOSpine (paid directly to institution/employer); S.T.Y.: stock ownership: Phygen, Alphatec; Meditech, royalties Meditech Advisors, Stryker Spine (Paid directly to institution/employer), grant from AOSpine (Paid directly to institution/ employer), research support from Biomet (Research support given to AREF), non financial research support from Nuvasive and Medtronic; J.C.W.: Royalties: Aesculap, Biomet, Amedica, Seaspine, Synthes; Stock Ownership: Fziomed; Private Investments: Promethean Spine, Paradigm spine, Benevenue, NexGen, Vertiflex, electrocore, surgitech, corespine, expanding orthopaedics, osprey, bone biologics, curative biosciences, pearldiver; Board of Directors: North American Spine Society (non-financial, reimbursement for travel for board meetings, courses, etc...), North American Spine Foundation (non-financial), Cervical Spine Research Society (non-financial, reimbursement for travel for board meetings), AO Spine/AO Foundation (honorariums for board position); Fellowship Support: AO Foundation (spine fellowship funding paid to institution); J.A.Y.: royalties: NuVasive, Osprey Medical, Amedica, Integra; stock ownership: Amedica, Benvenue Medical, Paradigm Spine, Promethean Surgical Devices, Spinal Ventures, VertiFlex, Spinicity, ISD, Providence Medical; private investments: Amedica, VertiFlex, Benvenue, NuVasive; consulting: Integra, NuVasive, Amedica, HealthTrust; board of directors: Durango Orthopedic Associates (none); research support (staff and/or materials): Globus Medical (paid directly to institution/employer), NuVasive (paid directly to institution/employer), VertiFlex (paid directly to institution/employer), Integra (paid directly to institution/employer).

Publisher Copyright:
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.

Keywords

age
neck-related complications
PearlDiver database
posterior cervical fusion
retrospective study
rhBMP2
sex
upper cervical spine
wound-related complications

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10.1097/BSD.0000000000000443

Cite this

@article{7b43c30b4c3b46ce9b57b479050e7280,

title = "Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion",

abstract = "Study Design: A retrospective cohort study. Objective: To compare the complications between posterior cervical fusions with and without recombinant human bone morphogenetic protein 2 (rhBMP2). Summary of Background Data: Use of rhBMP2 in anterior cervical spinal fusion procedures can lead to potential complications such as neck edema, resulting in airway complications or neurological compression. However, there are no data on the complications associated with the {"}off-label{"} use of rhBMP2 in upper and lower posterior cervical fusion approaches. Materials and Methods: Patients from the PearlDiver database who had a posterior cervical fusion between 2005 and 2011 were identified. We evaluated complications within 90 days after fusion and data was divided in 2 groups: (1) posterior cervical fusion including upper cervical spine O-C2 (upper group) and (2) posterior cervical fusion including lower cervical spine C3-C7 (lower group). Complications were divided into: any complication, neck-related complications, wound-related complications, and other complications. Results: Of the 352 patients in the upper group, 73 patients (20.7%) received rhBMP2, and 279 patients (79.3%) did not. Likewise, in the lower group of 2372 patients, 378 patients (15.9%) had surgery with rhBMP2 and 1994 patients (84.1%) without. In the upper group, complications were observed in 7 patients (9.6%) with and 34 patients (12%) without rhBMP2. In the lower group, complications were observed in 42 patients (11%) with and 276 patients (14%) without rhBMP2. Furthermore, in the lower group the wound-related complications were significantly higher in the rhBMP2 group (23 patients, 6.1%) compared with the non-rhBMP2 group (75 patients, 3.8%). Conclusions: Our data showed that the use of rhBMP2 does not increase the risk of complications in upper cervical spine fusion procedures. However, in the lower cervical spine, rhBMP2 may elevate the risk of wound-related complications. Overall, there were no major complications associated with the use of rhBMP2 for posterior cervical fusion approaches. Level of Evidence: Level III.",

keywords = "age, neck-related complications, PearlDiver database, posterior cervical fusion, retrospective study, rhBMP2, sex, upper cervical spine, wound-related complications",

author = "Shinji Takahashi and Zorica Buser and Cohen, {Jeremiah R.} and Allison Roe and Myhre, {Sue L.} and Meisel, {Hans Joerg} and Brodke, {Darrel S.} and Yoon, {S. Tim} and Park, {Jong Beom} and Wang, {Jeffrey C.} and Youssef, {Jim A.}",

note = "Funding Information: Z.B.: Xenco Medical (consultancy); J.R.C.: AOSpine (paid to acquire data); H.J.M.: consultancy (money paid to institution): Zyga, DiFusion, Regenerate Life Sciences GmbH (past); royalties: Aesculap (past), Medtronic, Fehling; stock/stock options (money paid to institution): DiFusion, Regenerate Life Sciences GmbH (past); D.S.B.: royalties: Amedica, DePuy Synthes, Medtronic; stock ownership: Amedica; consulting: Amedica, Vallum and DePuy Synthes; fellowship support: AOSpine (paid directly to institution/employer); S.T.Y.: stock ownership: Phygen, Alphatec; Meditech, royalties Meditech Advisors, Stryker Spine (Paid directly to institution/employer), grant from AOSpine (Paid directly to institution/ employer), research support from Biomet (Research support given to AREF), non financial research support from Nuvasive and Medtronic; J.C.W.: Royalties: Aesculap, Biomet, Amedica, Seaspine, Synthes; Stock Ownership: Fziomed; Private Investments: Promethean Spine, Paradigm spine, Benevenue, NexGen, Vertiflex, electrocore, surgitech, corespine, expanding orthopaedics, osprey, bone biologics, curative biosciences, pearldiver; Board of Directors: North American Spine Society (non-financial, reimbursement for travel for board meetings, courses, etc...), North American Spine Foundation (non-financial), Cervical Spine Research Society (non-financial, reimbursement for travel for board meetings), AO Spine/AO Foundation (honorariums for board position); Fellowship Support: AO Foundation (spine fellowship funding paid to institution); J.A.Y.: royalties: NuVasive, Osprey Medical, Amedica, Integra; stock ownership: Amedica, Benvenue Medical, Paradigm Spine, Promethean Surgical Devices, Spinal Ventures, VertiFlex, Spinicity, ISD, Providence Medical; private investments: Amedica, VertiFlex, Benvenue, NuVasive; consulting: Integra, NuVasive, Amedica, HealthTrust; board of directors: Durango Orthopedic Associates (none); research support (staff and/or materials): Globus Medical (paid directly to institution/employer), NuVasive (paid directly to institution/employer), VertiFlex (paid directly to institution/employer), Integra (paid directly to institution/employer). Publisher Copyright: Copyright {\textcopyright} 2016 Wolters Kluwer Health, Inc. All rights reserved.",

year = "2017",

doi = "10.1097/BSD.0000000000000443",

language = "English",

volume = "30",

pages = "E1269--E1273",

journal = "Clinical Spine Surgery",

issn = "2380-0186",

publisher = "Lippincott Williams and Wilkins Ltd.",

number = "9",

}

TY - JOUR

T1 - Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion

AU - Takahashi, Shinji

AU - Buser, Zorica

AU - Cohen, Jeremiah R.

AU - Roe, Allison

AU - Myhre, Sue L.

AU - Meisel, Hans Joerg

AU - Brodke, Darrel S.

AU - Yoon, S. Tim

AU - Park, Jong Beom

AU - Wang, Jeffrey C.

AU - Youssef, Jim A.

N1 - Funding Information: Z.B.: Xenco Medical (consultancy); J.R.C.: AOSpine (paid to acquire data); H.J.M.: consultancy (money paid to institution): Zyga, DiFusion, Regenerate Life Sciences GmbH (past); royalties: Aesculap (past), Medtronic, Fehling; stock/stock options (money paid to institution): DiFusion, Regenerate Life Sciences GmbH (past); D.S.B.: royalties: Amedica, DePuy Synthes, Medtronic; stock ownership: Amedica; consulting: Amedica, Vallum and DePuy Synthes; fellowship support: AOSpine (paid directly to institution/employer); S.T.Y.: stock ownership: Phygen, Alphatec; Meditech, royalties Meditech Advisors, Stryker Spine (Paid directly to institution/employer), grant from AOSpine (Paid directly to institution/ employer), research support from Biomet (Research support given to AREF), non financial research support from Nuvasive and Medtronic; J.C.W.: Royalties: Aesculap, Biomet, Amedica, Seaspine, Synthes; Stock Ownership: Fziomed; Private Investments: Promethean Spine, Paradigm spine, Benevenue, NexGen, Vertiflex, electrocore, surgitech, corespine, expanding orthopaedics, osprey, bone biologics, curative biosciences, pearldiver; Board of Directors: North American Spine Society (non-financial, reimbursement for travel for board meetings, courses, etc...), North American Spine Foundation (non-financial), Cervical Spine Research Society (non-financial, reimbursement for travel for board meetings), AO Spine/AO Foundation (honorariums for board position); Fellowship Support: AO Foundation (spine fellowship funding paid to institution); J.A.Y.: royalties: NuVasive, Osprey Medical, Amedica, Integra; stock ownership: Amedica, Benvenue Medical, Paradigm Spine, Promethean Surgical Devices, Spinal Ventures, VertiFlex, Spinicity, ISD, Providence Medical; private investments: Amedica, VertiFlex, Benvenue, NuVasive; consulting: Integra, NuVasive, Amedica, HealthTrust; board of directors: Durango Orthopedic Associates (none); research support (staff and/or materials): Globus Medical (paid directly to institution/employer), NuVasive (paid directly to institution/employer), VertiFlex (paid directly to institution/employer), Integra (paid directly to institution/employer). Publisher Copyright: Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.

PY - 2017

Y1 - 2017

N2 - Study Design: A retrospective cohort study. Objective: To compare the complications between posterior cervical fusions with and without recombinant human bone morphogenetic protein 2 (rhBMP2). Summary of Background Data: Use of rhBMP2 in anterior cervical spinal fusion procedures can lead to potential complications such as neck edema, resulting in airway complications or neurological compression. However, there are no data on the complications associated with the "off-label" use of rhBMP2 in upper and lower posterior cervical fusion approaches. Materials and Methods: Patients from the PearlDiver database who had a posterior cervical fusion between 2005 and 2011 were identified. We evaluated complications within 90 days after fusion and data was divided in 2 groups: (1) posterior cervical fusion including upper cervical spine O-C2 (upper group) and (2) posterior cervical fusion including lower cervical spine C3-C7 (lower group). Complications were divided into: any complication, neck-related complications, wound-related complications, and other complications. Results: Of the 352 patients in the upper group, 73 patients (20.7%) received rhBMP2, and 279 patients (79.3%) did not. Likewise, in the lower group of 2372 patients, 378 patients (15.9%) had surgery with rhBMP2 and 1994 patients (84.1%) without. In the upper group, complications were observed in 7 patients (9.6%) with and 34 patients (12%) without rhBMP2. In the lower group, complications were observed in 42 patients (11%) with and 276 patients (14%) without rhBMP2. Furthermore, in the lower group the wound-related complications were significantly higher in the rhBMP2 group (23 patients, 6.1%) compared with the non-rhBMP2 group (75 patients, 3.8%). Conclusions: Our data showed that the use of rhBMP2 does not increase the risk of complications in upper cervical spine fusion procedures. However, in the lower cervical spine, rhBMP2 may elevate the risk of wound-related complications. Overall, there were no major complications associated with the use of rhBMP2 for posterior cervical fusion approaches. Level of Evidence: Level III.

AB - Study Design: A retrospective cohort study. Objective: To compare the complications between posterior cervical fusions with and without recombinant human bone morphogenetic protein 2 (rhBMP2). Summary of Background Data: Use of rhBMP2 in anterior cervical spinal fusion procedures can lead to potential complications such as neck edema, resulting in airway complications or neurological compression. However, there are no data on the complications associated with the "off-label" use of rhBMP2 in upper and lower posterior cervical fusion approaches. Materials and Methods: Patients from the PearlDiver database who had a posterior cervical fusion between 2005 and 2011 were identified. We evaluated complications within 90 days after fusion and data was divided in 2 groups: (1) posterior cervical fusion including upper cervical spine O-C2 (upper group) and (2) posterior cervical fusion including lower cervical spine C3-C7 (lower group). Complications were divided into: any complication, neck-related complications, wound-related complications, and other complications. Results: Of the 352 patients in the upper group, 73 patients (20.7%) received rhBMP2, and 279 patients (79.3%) did not. Likewise, in the lower group of 2372 patients, 378 patients (15.9%) had surgery with rhBMP2 and 1994 patients (84.1%) without. In the upper group, complications were observed in 7 patients (9.6%) with and 34 patients (12%) without rhBMP2. In the lower group, complications were observed in 42 patients (11%) with and 276 patients (14%) without rhBMP2. Furthermore, in the lower group the wound-related complications were significantly higher in the rhBMP2 group (23 patients, 6.1%) compared with the non-rhBMP2 group (75 patients, 3.8%). Conclusions: Our data showed that the use of rhBMP2 does not increase the risk of complications in upper cervical spine fusion procedures. However, in the lower cervical spine, rhBMP2 may elevate the risk of wound-related complications. Overall, there were no major complications associated with the use of rhBMP2 for posterior cervical fusion approaches. Level of Evidence: Level III.

KW - age

KW - neck-related complications

KW - PearlDiver database

KW - posterior cervical fusion

KW - retrospective study

KW - rhBMP2

KW - sex

KW - upper cervical spine

KW - wound-related complications

UR - http://www.scopus.com/inward/record.url?scp=85032269109&partnerID=8YFLogxK

U2 - 10.1097/BSD.0000000000000443

DO - 10.1097/BSD.0000000000000443

M3 - Article

C2 - 27632774

AN - SCOPUS:85032269109

SN - 2380-0186

VL - 30

SP - E1269-E1273

JO - Clinical Spine Surgery

JF - Clinical Spine Surgery

IS - 9

ER -

Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion

Abstract

Bibliographical note

Keywords

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