Biologics to Promote Spinal Fusion

McKay, Benjamin; Peckham, Steve; Scifert, Jeff

doi:10.1016/b978-012369390-7/50010-1

Cited by 4 publications

(4 citation statements)

References 155 publications

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“…4 This also includes the US Food and Drug Administration-authenticated collagen carrier products containing rhBMP-2 and rhBMP-7 (INFUSE Bone Graft; Medtronic Spinal and Biologics, Memphis, Tennessee). 2,4 Recombinant human BMP-2 has been proven to actively promote bone fusion in human as well as nonhuman species with a better efficacy than that of autogenous iliac bone, 6,7 which results in its wide application in spinal fusion, fracture healing, and dental tissue engineering. 8 It has been reported that adequate production of rhBMP-2 with a good biological activity was yielded from E coli-derived rhBMP-2 (ErhBMP-2) through modification of the preparation method.…”

mentioning

confidence: 99%

Osteoinductive Activity of ErhBMP-2 After Anterior Cervical Diskectomy and Fusion With a ß-TCP Interbody Cage in a Goat Model

Wang¹,

Zhang²,

Lv³

et al. 2014

Orthopedics

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Bone morphogenetic protein (BMP)-2 induces bone and cartilage tissue formation. Large amounts of BMP-2 are difficult to purify or to produce in vitro using eukaryotic cells. The goal of the present study was to assess the clinical use of Escherichia coli-derived recombinant human BMP-2 (ErhBMP-2) on bone fusion after cervical and lumbar spine surgery in a goat model, compared with the standard autogenous iliac bone grafting. Thirty-six goats were randomized to 3 groups: (A) autogenous iliac bone grafting, (B) cervical interbody fusion cage containing ß-tricalcium phosphate (ß-TCP), or (C) cervical interbody fusion cage containing ß-TCP+ErhBMP-2 (2.5 mg). Cervical bone repair was evaluated using radiographs and computed tomography scans at 0, 3, and 6 months. Histological analyses were performed on cervical samples. Two goats died from infection. The differences in intervertebral height among the groups were not significant 3 months postoperatively but became significant after 6 months between groups A vs B and C (P=.04); there was no difference between groups B and C at 6 months. Adding ErhBMP-2 significantly increased cervical fusion at 6 months (P=.04). Histological examinations showed that ß-TCP+ErhBMP-2 increased new bone area, material degradation rate, and depth of tissue penetration and decreased residual material area, all in a time-dependent manner. Escherichia coli-derived rhBMP-2 combined with an enhanced fusion cage containing ß-TCP induced bone formation in a goat model. Furthermore, its ability to promote bone fusion was similar to autogenous iliac bone grafting.

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mentioning

confidence: 99%

Osteoinductive Activity of ErhBMP-2 After Anterior Cervical Diskectomy and Fusion With a ß-TCP Interbody Cage in a Goat Model

Wang¹,

Zhang²,

Lv³

et al. 2014

Orthopedics

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“…rhBMP-2 has been studied extensively in preclinical spine fusion models in several species, including non-human primates [13,14]. These studies consistently showed rhBMP-2 to be equivalent and, in many cases, superior to autogenous bone.…”

Section: Spinal Applicationsmentioning

confidence: 96%

A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE® Bone Graft)

McKay

Peckham

Badura

2007

International Orthopaedics (SICO

534

388

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The combination of recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) carrier has been shown to induce bone formation in a number of preclinical and clinical investigations. In 2002, rhBMP-2/ACS at a 1.5-mg/cc concentration (INFUSE Bone Graft, Medtronic Spinal and Biologics, Memphis, TN) was FDA-approved as an autograft replacement for certain interbody spinal fusion procedures. In 2004, INFUSE Bone Graft was approved for open tibial fractures with an intermedullary (IM) nail fixation. Most recently, in March 2007, INFUSE Bone Graft was approved as an alternative to autogenous bone grafts for sinus augmentations, and for localised alveolar ridge augmentations for defects associated with extraction sockets. The culmination of extensive preclinical and clinical research and three FDA approvals makes rhBMP-2 one of the most studied, published and significant advances in orthopaedics. This review article summarises a number of clinical findings of rhBMP-2/ACS, including the FDA-approved investigational device exemption (IDE) studies used in gaining the aforementioned approvals.

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“…7 Ada dua bentuk TCP yaitu alfa (α) dan beta (β) TCP. 8 Penggunaan β-TCP biasanya dalam bentuk granul dan blok sementara α-TCP yang lebih mudah larut dan reaktif biasanya digunakan sebagai serbuk untuk membuat calcium phosphate cement (CPC). 9 Bentuk blok sulit dibentuk saat operasi dan dipaskan dengan permukaan tulang.…”

Section: Pendahuluanunclassified

Kekuatan kompresi semen alpha tricalcium phosphate dengan komposisi larutan sodium yang berbeda

Ruslin,

Larnani,

Nursalim

et al. 2023

MKGK

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Calcium phosphate cement (CPC) merupakan campuran dari cairan dan serbuk yang mengandung calcium phosphate. Kelebihan CPC dibandingkan dengan bone graft lain adalah dapat menyesuaikan defek tulang, mengeras pada in vivo, dan biokompatibel. Kekurangan dari CPC adalah kekuatan mekanik yang rendah. Reaksi setting dan mengerasnya CPC dikarenakan adanya ikatan antar kristal apatite yang berpresipitasi. Cairan yang mengandung ion fosfat biasanya digunakan sebagai campuran untuk mempercepat reaksi setting. Tujuan dari penelitian ini adalah untuk mengetahui perbedaan kekuatan kompresi semen alpha tricalcium phosphate (α-TCP) dengan penggunaan larutan disodium hydrogen phosphate (Na2HPO4) dan sodium dihydrogen phosphate (NaH2PO4). Sebanyak 12 sampel semen α-TCP dibuat dengan ukuran diameter 3 mm dan tinggi 6 mm. Sampel penelitian dibagi menjadi 2 kelompok perlakuan, kelompok pertama campuran serbuk dan larutan Na2HPO4 dan kelompok kedua campuran serbuk α-TCP dan larutan NaH2PO4. Sampel kemudian direndam dalam larutan saline selama 24 jam pada suhu 37 °C. Setelah perendaman selesai, sampel diuji dengan menggunakan universal testing machine (UTM). Data yang diperoleh dimasukkan ke dalam rumus untuk mengetahui kekuatan kompresinya. Data kemudian dianalisis dengan menggunakan independent sample t-test dengan tingkat signifikansi 95%. Rerata kekuatan kompresi semen α-TCP dengan penggunaan larutan Na2HPO4 dan NaH2PO4 adalah 44,51 ± 4,22 MPa dan 21,52 ± 1,85 MPa. Hasil analisis statistik menunjukkan adanya perbedaan yang signifikan pada penggunaan kedua larutan (p < 0,05). Kesimpulan penelitian ini adalah terdapat perbedaan kekuatan kompresi yang signifikaan antara semen α- TCP dengan penggunaan larutan Na2HPO4 NaH2PO44. Kekuatan kompresi semen α-TCP dengan penggunaan larutan Na2HPO4 lebih tinggi daripada semen α-TCP dengan penggunaan larutan NaH2PO4.

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Biologics to Promote Spinal Fusion

Cited by 4 publications

References 155 publications

Osteoinductive Activity of ErhBMP-2 After Anterior Cervical Diskectomy and Fusion With a ß-TCP Interbody Cage in a Goat Model

Osteoinductive Activity of ErhBMP-2 After Anterior Cervical Diskectomy and Fusion With a ß-TCP Interbody Cage in a Goat Model

A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE® Bone Graft)

Kekuatan kompresi semen alpha tricalcium phosphate dengan komposisi larutan sodium yang berbeda

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