Is INFUSE Bone Graft Superior to Autograft Bone? An Integrated Analysis of Clinical Trials Using the LT-CAGE Lumbar Tapered Fusion Device

Burkus, J. Kenneth; Heim, Stephen E.; Gornet, Matthew F.; Zdeblick, Thomas A.

doi:10.1097/00024720-200304000-00001

Cited by 289 publications

(164 citation statements)

References 15 publications

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“…Use of rhBMP-2 and other bone morphogenetic proteins for enhancing osteoblastic activity and accelerating spinal fusion is well documented [2,4,7,10]. Observations from this study also showed that an improvement in clinical outcome was seen in all patients.…”

Section: Discussionsupporting

confidence: 62%

Posterior lumbar interbody fusion using rhBMP-2

et al. 2008

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The use of biological technologies for the treatment of degenerative spinal diseases has undergone rapid clinical and scientific development. BMP strategies have gained wide support for an inherent potential to improve the ossification process. It has been extensively studied in combination with various techniques for spinal stabilisation from both anterior and posterior approach. We studied the fusion process after implantation of rhBMP-2 in 17 patients with degenerative lumbar spine diseases in combination with dorsal fixation with pedicle screws and poly-ether-ether-ketone (PEEK) interbody cages. We used 12 mg rhBMP-2 carried by collagen sponge, 6 mg in every cage. Patient follow up consisted of pre-operative radiographic and clinical evaluation. Similar post-operative evaluations were performed at 3 and 6 months. Clinical assessment demonstrated clear improvement in all patients despite evidence of vertebral endplate osteoclastic activity in the 3-month radiographs. The 6-month radiograph, however, confirmed evidence of fusion, and no untoward results or outcomes were noted. While previous studies have shown exclusively positive results in both fusion rates and process, our study demonstrated an intermediate morphology at 3 months during the ossification process using Induct Os in combination with peek-cages using a PLIF-technique. The transient resorption of bone surrounding the peek cage did not result in subsidence, pain or complication, and fusion was reached in all cases within a 6-month-controlled evaluation. Although there was no negative influence on clinical outcome, the potential for osteoclastic or metabolic resorption bears watching during the post-surgical follow up.

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Section: Discussionsupporting

confidence: 62%

Posterior lumbar interbody fusion using rhBMP-2

et al. 2008

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“…The clinical performance of each of these products has been comparable to autografts in certain BTE applications [55,56], and both products have received FDA approval for limited indications [55,57].…”

Section: Bmp-2mentioning

confidence: 99%

The Potential Impact of Bone Tissue Engineering in the Clinic

et al. 2016

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Bone tissue engineering (BTE) intends to restore structural support for movement and mineral homeostasis, and assist in hematopoiesis and the protective functions of bone in traumatic, degenerative, cancer, or congenital malformation. While much effort has been put into BTE, very little of this research has been translated to the clinic. In this review, we discuss current regenerative medicine and restorative strategies that utilize tissue engineering approaches to address bone defects within a clinical setting. These approaches involve the primary components of tissue engineering: cells, growth factors and biomaterials discussed briefly in light of their clinical relevance. This review also presents upcoming advanced approaches for BTE applications and suggests a probable workpath for translation from the laboratory to the clinic.

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“…This particular carrier was optimized for use in the interbody space inside a structural element (cage), and higher doses (up to 40 mg) with composite carriers composed of collagen and ceramic have been optimized for use in posterolateral spinal fusion but have not yet gained FDA approval [18][19][20][21] . Achievement of radiographic evidence of successful interbody fusion with this technique can be as high as 98% on the basis of computed tomographic (CT) scan evaluation, with superiority over autogenous bone graft 22 . Moreover, recent data based on review of a large administrative database [23][24][25] suggest that INFUSE can be effective in patients who are older than sixty years and in patients who smoke and that INFUSE does not result in increased complications (except when used in high doses in the cervical spine).…”

Section: Current Status Of Osteoinductive Agents For Spine Fusionmentioning

confidence: 99%