Instrumented One and Two Level Posterolateral Fusions With Recombinant Human Bone Morphogenetic Protein-2 and Allograft

Stambough, Jeffery L.; Clouse, Elisha K.; Stambough, Jeffrey B.

doi:10.1097/brs.0b013e3181c46c3a

Cited by 10 publications

(6 citation statements)

References 18 publications

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“…The conclusion was in favour of the use of BMP-2 (Table 10) [42,43]. The same conclusion was made by Stambough et al [44] in PLF using, in association with BMP-2, freeze-dried corticocancellous allograft and local autogenous bone graft (Table 10). They have no control group but they obtain a high fusion rate (97.2 %).…”

Section: % 3%supporting

confidence: 52%

Growth factors in orthopaedic surgery: demineralized bone matrix versus recombinant bone morphogenetic proteins

Hinsenkamp

Collard

2014

International Orthopaedics (SICOT)

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During recent decades the utilisation of growth factors, especially BMPs, has received an increasing interest in orthopaedic surgery. For clinical implantation the two main options are demineralised bone matrix (DBM) and recombinant bone morphogenetic proteins (rhBMP). Many clinical studies agree on an equivalent osteoinductive effect between DBM, BMPs and autologous bone graft; however, the different origins and processing of DBM and rhBMP may introduce some fluctuations. Their respective characteristics are reviewed and possible interactions with their effectiveness are analysed. The main difference concerns the concentration of BMPs, which varies to an order of magnitude of 106 between DBM and rhBMPs. This may explain the variability in efficiency of some products and the adverse effects. Currently, considering osteoinductive properties, safety and availability, the DBM seems to offer several advantages. However, if DBM and rhBMPs are useful in some indications, their effectiveness and safety can be improved and more evidence-based studies are needed to better define the indications.

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Section: % 3%supporting

confidence: 52%

Growth factors in orthopaedic surgery: demineralized bone matrix versus recombinant bone morphogenetic proteins

Hinsenkamp

Collard

2014

International Orthopaedics (SICOT)

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“…In a CT-based study, fusion rates of 97.2% were achieved for instrumented one- and two-level posterolateral fusions utilizing INFUSE (rhBMP-2 dose of 12 mg/1.5 mg/ml) with allograft, and lamina and spinous process autograft. [13] One additional study found that the frequency of wound complications and anaphylaxis was not increased for 96 patients reexposed to INFUSE. [3] Each patient had a minimum of two operations utilizing INFUSE.…”

Section: Resultsmentioning

confidence: 99%

Pros, cons, and costs of INFUSE in spinal surgery

Epstein¹

2011

Surg Neurol Int

122

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Background:INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP-2]; Medtronic, Memphis, TN, USA) is approved by the Federal Drug Administration (FDA) only for use with the lumbar tapered fusion device (LT Cage; Medtronic) to perform single-level anterior lumbar interbody fusions (ALIF: L2-S1 levels). INFUSE, however, is widely utilized in an “off-label” capacity for anterior and/or posterior cervical, thoracic, and lumbar surgery. Nevertheless, Medicare and other insurance companies, are now increasingly denying reimbursement (average cost of a “large” INFUSE to the hospital without overhead $5000-6000) to hospitals for INFUSE when utilized “off-label”.Methods:This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors.Results:There are multiple cons of utilizing INFUSE in an “off-label” capacity for spinal surgery. Direct contraindications include pregnancy, allergy to titanium, allergy to bovine type I collagen or rhBMP-2, infection, tumor, liver or kidney disease, immunosuppression (e.g., lupus, HIV/AIDS); contraindications are also seen in those receiving radiation, chemotherapy, or steroids. Reported complications include exuberant/ectopic bone formation, paralysis (cord, nerve damage), dural tears, bowel–bladder and sexual dysfunction, respiratory failure, inflammation of adjacent tissues, fetal developmental complications, scar, excessive bleeding, and even death. Complications are so prevalent in the anterior cervical spine, that many surgeons no longer use it in this region. Similarly, INFUSE complications and indications for posterior lumbar interbody fusions (PLIFs) and transforaminal interbody lumbar fusions (TLIFs) should also be reexamined.Conclusions:More surgeons need to question the safety, efficacy, and appropriate “off-label” use of INFUSE in all spine surgeries.

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“…Our analysis included 9 papers [26][27][28]36,45,53,76,82,86 that reported the efficacy and complications of BMP in PLF procedures ( Table 6). Seven studies were case-control studies, [26][27][28]45,53,76,86 whereas 2 were case series.…”

Section: Posterolateral Lumbar Fusionmentioning

confidence: 99%

Exploratory meta-analysis on dose-related efficacy and morbidity of bone morphogenetic protein in spinal arthrodesis surgery

Hofstetter

Hofer

Levi

2016

SPI

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OBJECT Bone morphogenetic protein (BMP) is frequently used for spinal arthrodesis procedures in an “off-label” fashion. Whereas complications related to BMP usage are well recognized, the role of dosage is less clear. The objective of this meta-analysis was to assess dose-dependent effectiveness (i.e., bone fusion) and morbidity of BMP used in common spinal arthrodesis procedures. A quantitative exploratory meta-analysis was conducted on studies reporting fusion and complication rates following anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), and posterolateral lumbar fusion (PLF) supplemented with BMP. METHODS A literature search was performed to identify studies on BMP in spinal fusion procedures reporting fusion and/or complication rates. From the included studies, a database for each spinal fusion procedure, including patient demographic information, dose of BMP per level, and data regarding fusion rate and complication rates, was created. The incidence of fusion and complication rates was calculated and analyzed as a function of BMP dose. The methodological quality of all included studies was assessed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were analyzed using a random-effects model. Event rates are shown as percentages, with a 95% CI. RESULTS Forty-eight articles met the inclusion criteria: ACDF (n = 7), PCF (n = 6), ALIF (n = 9), TLIF/PLIF (n = 17), and PLF (n = 9), resulting in a total of 5890 patients. In ACDF, the lowest BMP concentration analyzed (0.2–0.6 mg/level) resulted in a fusion rate similar to the highest dose (1.1–2.1 mg/level), while permitting complication rates comparable to ACDF performed without BMP. The addition of BMP to multilevel constructs significantly (p < 0.001) increased the fusion rate (98.4% [CI 95.4%–99.4%]) versus the control group fusion rate (85.8% [CI 77.4%–91.4%]). Studies on PCF were of poor quality and suggest that BMP doses of ≤ 2.1 mg/level resulted in similar fusion rates as higher doses. Use of BMP in ALIF increased fusion rates from 79.1% (CI 57.6%–91.3%) in the control cohort to 96.9% (CI 92.3%–98.8%) in the BMP-treated group (p < 0.01). The rate of complications showed a positive correlation with the BMP dose used. Use of BMP in TLIF had only a minimal impact on fusion rates (95.0% [CI 92.8%–96.5%] vs 93.0% [CI 78.1%–98.0%] in control patients). In PLF, use of ≥ 8.5 mg BMP per level led to a significant increase of fusion rate (95.2%; CI 90.1%–97.8%) compared with the control group (75.3%; CI 64.1%–84.0%, p < 0.001). BMP did not alter the rate of complications when used in PLF. CONCLUSIONS The BMP doses used for various spinal arthrodesis procedures differed greatly between studies. This study provides BMP dosing recommendations for the most common spine procedures.

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Instrumented One and Two Level Posterolateral Fusions With Recombinant Human Bone Morphogenetic Protein-2 and Allograft

Cited by 10 publications

References 18 publications

Growth factors in orthopaedic surgery: demineralized bone matrix versus recombinant bone morphogenetic proteins

Growth factors in orthopaedic surgery: demineralized bone matrix versus recombinant bone morphogenetic proteins

Pros, cons, and costs of INFUSE in spinal surgery

Exploratory meta-analysis on dose-related efficacy and morbidity of bone morphogenetic protein in spinal arthrodesis surgery

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