Singh K, Smucker JD, Gill S, et al. 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

Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA.
Journal of Spinal Disorders & Techniques (Impact Factor: 2.2). 09/2006; 19(6):416-23. DOI: 10.1097/00024720-200608000-00008
Source: PubMed


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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    • "The use of rhBMP-2 in posterolateral lumbar fusions is intended to enhance fusion mass and reduce donor side morbidity related to bone graft harvest [11] as described by Boden [12]. Singh [13] showed enhanced fusion rates for iliac crest bone graft in combination with rhBMP-2 compared to iliac crest bone graft alone. Following these promising results, rhBMP-2 utilization nationwide has increased to 28.1% of all fusion procedures [14]. "
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    ABSTRACT: Study design: Retrospective cohort study of 1430 patients undergoing lumbar spinal fusion from 2002 - 2009. Objective: The goal of this study was to compare and evaluate the number of complications requiring reoperation in elderly versus younger patients.Summary of background data: rhBMP-2 has been utilized off label for instrumented lumbar posterolateral fusions for many years. Many series have demonstrated predictable healing rates and reoperations. Varying complication rates in elderly patients have been reported.Materials and methods: All patients undergoing instrumented lumbar posterolateral fusion of <= 3 levels consenting to utilization of rhBMP-2 were retrospectively evaluated. Patient demographics, body mass index, comorbidities, number of levels, associated interbody fusion, and types of bone void filler were analyzed. The age of patients were divided into less than 65 and greater than or equal to 65 years. Complications related to the performed procedure were recorded. RESULTS: After exclusions, 482 consecutive patients were evaluated with 42.1% males and 57.9% females. Average age was 62 years with 250 (51.9%) < 65 and 232 (48.1%) >= 65 years. Patients >= 65 years of age stayed longer (5.0 days) in the hospital than younger patients (4.5 days) (p=0.005).Complications requiring reoperation were: acute seroma formation requiring decompression 15/482, 3.1%, bone overgrowth 4/482, 0.8%, infection requiring debridement 11/482, 2.3%, and revision fusion for symptomatic nonunion 18/482, 3.7% . No significant differences in complications were diagnosed between the two age groups. Statistical differences were noted between the age groups for medical comorbidities and surgical procedures. Patients older than 65 years underwent longer fusions (2.1 versus 1.7 levels, p=0.001). DISCUSSION: Despite being older and having more comorbidities, elderly patients have similar complication and reoperation rates compared to younger healthier patients undergoing instrumented lumbar decompression fusions with rhBMP-2.
    Journal of Orthopaedic Surgery and Research 01/2013; 8(1):1. DOI:10.1186/1749-799X-8-1 · 1.39 Impact Factor
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    • "Therefore, precise assessments of the fusion rates are critical, and the use of fine-cut CT scans with sagittal and coronal reconstructions might increase the accuracy of fusion assessments.24) Therefore, the use of 3D-CT to evaluate the presence of a successful arthrodesis is a major strength of the present study because thin-section CT scans allow bony discontinuities to be discerned more easily.14) "
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    ABSTRACT: Porous β-calcium pyrophosphate (β-CPP) was developed to improve the fusion success of posterolateral lumbar fusion (PLF). The possibility of accomplishing PLF using a mixture of porous β-CPP and iliac bone was studied. This paper reports the radiologic results of PLF using the β-CPP plus autograft for lumbar degenerative disease as a bone graft extender. A prospective, case-matched, radiographic study evaluating the results of short segment lumbar fusion using a β-CPP plus autograft was performed to compare the efficacy of β-CPP plus autograft with that of an autograft alone for short segment lumbar fusion. Thirty one consecutive patients (46 levels) underwent posterolateral fusion with pedicle screw fixation and additional posterior lumbar interbody fusion. In all patients, 3 mL of β-CPP plus 3 mL of autogenous bone graft was placed randomly in one side of a posterolateral gutter, and 6 mL of autogenous iliac bone graft was placed on the other. The fusion rates, volumes of fusion masses, and bone absorption percentage were evaluated postoperatively using simple radiographs and 3 dimensional computed tomography (3D-CT) scans. The control sides treated with an autograft showed significantly better Lenke scores than the study sides treated with β-CPP at 3 and 6 months postoperatively, but there was no difference between the two sides at 12 months. The fusion rates (confirmed by 3D-CT) were 87.0% in the β-CPP group and 89.1% in the autograft group, which were not significantly different. The fusion mass volumes and bone absorption percentage at 12 months postoperatively were 2.49 mL (58.4%) and 1.89 mL (69.5%) for the β-CPP and autograft groups, respectively, and mean fusion mass volume was significantly higher in the β-CPP group. β-CPP combined with an autograft is as effective as autologous bone for grafting during instrumented posterolateral spinal fusion. These findings suggest that β-CPP bone chips can be used as a novel bone graft extender for short-segment posterolateral spinal fusion.
    Clinics in orthopedic surgery 09/2011; 3(3):238-44. DOI:10.4055/cios.2011.3.3.238
    • "There have been multiple studies giving conflicting accounts on the complications and/or efficacy of rhBMP-2 in both off and on label use.[671416181923–30] Due to concern for soft tissue swelling and airway compromise in anterior cervical spine fusion with rhBMP-2,[631–34] the FDA recently issued a public health notification, prompting further scrutiny of off-label use of rhBMP-2. "
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    ABSTRACT: There have been few reports on the use of recombinant human bone morphogenetic protein (rhBMP)-2 in posterior spine. However, no study has investigated the dosing, safety, and efficacy of its use in the posterior atlantoaxial, and/or craniovertebral junction. Recent case report of the cytokine-mediated inflammatory reaction, following off label use of rhBMP-2 as an adjunct for cervical fusion, particularly in complex cases, has increased concern about complications associated with the product. To assess the safety, efficacy, and dosing of rhBMP-2 as an adjunct for instrumented posterior atlantoaxial and/or craniovertebral junction arthrodesis. We included all patients treated by the senior author that included posterior atlantoaxial and/or craniovertebral junction instrumented fusion using rhBMP-2 from 2003 to 2008 with a minimum two year follow-up. Diagnosis, levels fused, rhBMP-2 dose, complications, and fusion were assessed. Twenty three patients with a mean age of 60.9 years (range 4 - 89 years) and an average follow-up of 45 months (range 27 to 84 months) met inclusion criteria. The indications for surgery included, atlantoaxial instability (n = 16), basilar invagination (n = 6), and kyphoscoliosis (n = 1). The specific pathologic diagnosis included type 2 dens fracture (n = 7), complex C1 and C2 ring fracture (n = 2), chordoma (n = 2), degenerative/osteoporosis (n = 3), rheumatoid disease (n = 8), and pseudogout (n = 1). The average rhBMP-2 dose was 2.38 mg/level, with a total of 76 levels treated (average 3.3 levels, SD= 1.4 levels). There were no complications. During the most recent follow-up, all patients had achieved fusion. In a series of patients with complex pathology and/or rheumatoid arthritis, 100% fusion rate was achieved with adjunct use of rhBMP-2, with a safe and effective average rhBMP-2 dose of 2.38 mg per level.
    Journal of craniovertebral junction and spine 07/2010; 1(2):107-12. DOI:10.4103/0974-8237.77674
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