Use of recombinant human bone morphogenetic protein-2 as an adjunct in posterolateral lumbar spine fusion: a prospective CT-scan analysis at one and two years.
ABSTRACT This study determines whether recombinant human bone morphogenetic protein-2 (rhBMP-2) (12 mg at the rate of 1.5 mg/mL) delivered on an absorbable collagen sponge with an added bulking agent can increase posterolateral lumbar spine fusion success rates and decrease time for fusion with autogenous bone grafts.
A prospective, single institution, clinical case-matched, radiographic, cohort study was undertaken. A total of 52 patients underwent posterolateral lumbar arthrodesis with pedicle screw instrumentation. The experimental group (n=41) underwent placement of Iliac crest bone graft (ICBG) with InFUSE (12 mg/level at the rate of 1.5 mg/mL). The control group (n=11) consisted of sex-matched patients, consecutively collected over the same time period with an instrumented posterolateral arthrodesis and ICBG placed in the intertransverse space.
Thin-cut (2 mm) axial, coronal, and sagittal reconstructions were blindly evaluated for evidence of bridging bone and cortication of the fusion mass by 3 separate reviewers. Fusions were graded and an overall score was given to the quality of the fusion mass.
Fifty patients (ICBG alone n=11; ICBG/rhBMP-2 n=39) were available for CT evaluation at 2-year follow-up. An overall 97% (68/70 levels; Definite+Probably Fused) fusion rate in the rhBMP-2 group was achieved as compared to the 77% fusion rate (17/22 levels) in the ICBG alone group (P<0.05). In the rhBMP-2 group, 92% of the patients (36/39 patients) received an overall excellent subjective fusion rating as compared to 27% (3/11) in the control group (P<0.05). There was no computed tomographic evidence of soft-tissue ossification, dural ossification, or laminar bone regrowth in any patient.
The adjunctive use of rhBMP-2 and ICBG seems to be safe and results in significantly larger and more consistent posterolateral fusion masses.
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ABSTRACT: 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.International Orthopaedics 10/2014; · 2.02 Impact Factor
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ABSTRACT: Hydroxyapatite (HA) is used as a bone-graft extender for posterolateral spinal fusion in human. It is also useful as an rhBMP-2 carrier because of its high affinity for rhBMP-2.The spine journal: official journal of the North American Spine Society 06/2014; · 2.90 Impact Factor
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ABSTRACT: The choice among the many options of approach and adjunct techniques in planning a posterior lumbar fusion can be problematic. Debates remain as to whether solid fusion has an advantage over pseudarthrosis regarding long-term symptom deterioration and whether an instrumented or a noninstrumented approach will best serve clinically and/or cost effectively, particularly in elderly patients. Increased motion resulting in higher rates of nonunion and the use of nonsteroidal anti-inflammatory drugs have been studied in animal models and are presumed risk factors, despite the lack of clinical investigation. Smoking is a proven risk factor for pseudarthrosis in both animal models and level III clinical studies. Recent long-term studies and image/clinical assessment of lumbar fusions and pseudarthrosis show that, although imaging remains a key area of difficulty in assessment, including an instrumented approach and a well-selected biologic adjunct, as well as achieving a solid fusion, all carry important long-term clinical advantages in avoiding revision surgery for nonunion.The Journal of the American Academy of Orthopaedic Surgeons 08/2014; 22(8):503-511. · 2.40 Impact Factor