![]() A variety of highly porous metal cage technologies has arisen in the past 5 years. The natural PEEK once dominated the design space for interbody cages and was the principal implant delivery system for bone morphogenetic protein-2 (BMP). In recent years, natural polyetheretherketone (PEEK) cages have been increasingly challenged in the spine fusion market, despite their widespread use, mostly due to concerns about their osseointegration. ![]() The physiology of posterolateral fusion also appears more sensitive to outside influences such as nicotine and nonsteroidal Posterolateral fusion presents mechanical hurdles such as limited surface for healing, a substantial gap between transverse processes which must be bridged, and the milieu of distractive rather than compressive forces. While INFUSE has proven effective for anterior interbody fusion, posterolateral spine fusion involves a more difficult healing environment. Patients underwent one-level (n=61), two-level (n=26), three-level (n=3), or four-level (n=1) fusion procedures. Preoperative diagnosis was disc pathology (n=20), spondylolisthesis (n=17), degenerative scoliosis (n=2), postdiscectomy instability (n=5), nonunion (n=12), spinal stenosis (n=26) and adjacent level degeneration (n=9). The 91 patients in this study included 55 females and 36 males with a mean age of 60 years (range 27–84 years). Bone graft extenders including local bone, allograft cancellous chips, demineralized bone matrix (Osteofil and Intergro), and HA/TCP ceramic (Mastergraft and Pro-osteon) were used at the discretion of the individual surgeon. All patients had concomitant pedicle screw/rod fixation (CD Horizon/Legacy). We reviewed clinical and radiographic data for 91 patients with minimum 2-year follow-up who underwent posterolateral spine fusion using INFUSE as an ICBG substitute. A comparative group, treated contemporaneously by posterolateral fusion with ICBG and evaluated with the same CT scan protocol, is also presented. Evaluation is based upon both plain radiographs and fine-cut computed tomographic (CT) scans at a minimum 2-year follow-up. The purpose of this study is to assess fusion rate for posterolateral spine fusion with INFUSE. Although the AMPLIFY preparation appears to be at least as effective as ICBG for posterolateral fusion, it uses a higher dose and concentration of rhBMP-2 than the clinically available INFUSE preparation. #Infuse bone trial#The largest body of available data is from an investigational device exemption trial for rhBMP-2 and an HA/TCP-collagen carrier (AMPLIFY rhBMP-2 Matrix). The experience with posterolateral fusion, has to this point been limited to small studies and short-term follow-up, ,. There is convincing evidence for the efficacy of INFUSE in conjunction with both lordotic threaded cages (LT cage) and threaded bone dowels for single-level ALIF. While some of these applications have been studied through FDA-approved investigational device exemption (IDE) trials, the majority of cases represent off-label use based on the surgeon's individual experience and judgment. These include multilevel anterior interbody fusion, posterolateral lumbar fusion, transforaminal and posterior lumbar interbody fusion, ,, and anterior cervical fusion. Although the approved indications were narrow, surgeons have subsequently used INFUSE in a range of fusion procedures. In July 2002 the Food and Drug Administration (FDA) approved recombinant human bone morphogenic protein-2 (rhBMP-2) and a collagen sponge carrier (INFUSE Bone Graft) as an iliac crest bone graft (ICBG) substitute for single-level anterior lumbar interbody fusion (ALIF). ![]() Despite these issues, this study presents compelling evidence that commercially available INFUSE is an effective ICBG substitute for one- and two-level posterolateral instrumented spine fusion. Finally, correlation between radiographic findings and clinical outcomes, and a cost-benefit analysis are needed. Additional studies are needed to determine the incremental benefit of a greater rhBMP-2 dose or use of alternative carriers for posterolateral fusion. The use of INFUSE is not a substitute for proper surgical technique or optimization of patient-related risk factors. As with ICBG, development of solid fusion or nonunion is a multifactorial process. Despite the lower dose and concentration of rhBMP-2, this study suggests that fusion success with INFUSE is equivalent to ICBG for posterolateral spine fusion. ![]() In contrast to prior studies, clinically available INFUSE delivers only 12 mg rhBMP-2 at a concentration of 1.5 mg/mL. ![]() Historically, only ICBG has been able to overcome these challenges and reliably generate a successful posterolateral lumbar spine fusion. Posterolateral spine fusion involves a more difficult healing environment with a limited surface for healing, a gap between transverse processes and the milieu of distractive forces. ![]()
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