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Scott D Boden - One of the best experts on this subject based on the ideXlab platform.
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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
Journal of Spinal Disorders & Techniques, 2006Co-Authors: Kern Singh, Joseph D Smucker, Scott D BodenAbstract:IntroductionThis 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 a
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the use of cultured bone marrow cells in type i collagen gel and porous hydroxyapatite for posterolateral lumbar Spine Fusion
Spine, 2005Co-Authors: Akihito Minamide, Munehito Yoshida, Mamoru Kawakami, Satoru Yamasaki, Hirotsugu Kojima, Hiroshi Hashizume, Scott D BodenAbstract:STUDY DESIGN Posterolateral lumbar transverse process Fusion was completed using the cultured bone marrow cells in type I collagen gel and porous hydroxyapatite. OBJECTIVE To compare the efficacy of cultured bone marrow cells with that of bone morphogenetic protein (BMP) as a graft alternative to autologous bone for posterolateral Spine Fusion. SUMMARY OF BACKGROUND DATA The clinical application of BMP for spinal Fusion may be limited by high dose and cost. Recently, mesenchymal stem cells have been studied in various fields because of their capability to differentiate into various cells, including those in the osteogenic lineage. METHODS Thirty adult rabbits were used. Each underwent single-level, bilateral, posterolateral intertransverse process Fusions at L4-L5. The animals were divided into 4 groups, each according to the material implanted: (1) autologous bone (autograft, n = 9); (2) porous hydroxyapatite (HA) particles and type I collagen sheet with 100 microg rhBMP-2 (BMP-HA, n = 7); (3) bone marrow cells (1 x 10(6) cells/mL, low-marrow-HA, n = 7); and (4) bone marrow cells (1 x 10(8) cells/mL, high-marrow-HA, n = 7). Before implantation for groups 3 and 4, fresh bone marrow cells from the iliac crest of each animal were cultured in a standard medium for 2 weeks. For one additional week, the marrow cells were cultured in 10(-8) M dexamethasone, type I collagen gel, and HA. Animals were euthanized 6 weeks after surgery. Spinal Fusions were evaluated by radiograph, manual palpation, and histology. RESULTS The Fusion rates were 4 of 7 in the autograft group, 7 of 7 in the BMP-HA group, 0 of 7 in the low-marrow-HA group, and 5 of 7 in the high-marrow-HA group. The histology in the BMP-HA and high-marrow-HA groups showed that grafted HA fragments were connected with mature new bone. The pores of HA fragments were filled up with bone matrix. In the low-marrow-HA group, fibrous tissue was predominant in the grafted fragments. CONCLUSIONS This study shows that the cultured bone marrow cells can act as a substitute for autograft or BMP in Spine Fusion. The current formulation may yield improved Fusion success and better quality of Fusion bone as compared to autograft.
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lower dose of rhbmp 2 achieves Spine Fusion when combined with an osteoconductive bulking agent in non human primates
Spine, 2005Co-Authors: Bryan Barnes, Scott D Boden, John Louisugbo, Patrick R Tomak, Jinsoo Park, Moon Soo Park, Akihito MinamideAbstract:Study Design. A non-human primate lumbar intertransverse process arthrodesis model was used to evaluate the effectiveness of different formulations of recombinant human bone morphogenetic protein-2 (rhBMP-2) to induce consistent bone formation. Objective. To determine if the combination of rhBMP-2/absorbable collagen sponge (ACS) wrapped around a bulking agent, consisting of a biphasic calcium phosphate/collagen composite, could achieve posterolateral Spine Fusion with a dose of rhBMP-2 (3.0 mg/side) that previously failed to induce posterolateral Fusion in rhesus monkeys with other carriers. Summary of Background Data. Successful bone induction in both human and non-human primates has required higher concentrations of BMP than were required in lower order models. The Food and Drug Administration approved concentration of rhBMP-2 for interbody Fusion (1.5 mg/mL) when delivered on the ACS alone without a bulking agent (doses 3-9 mg/side) has failed to induce clinically relevant amounts of bone formation in a posterolateral Spine Fusion model in rhesus monkeys. Previously, a higher concentration of 2.0 mg/mL of rhBMP-2 delivered on stacked sheets of a biphasic calcium phosphate ceramic/collagen compression resistant matrix (CRM) was required to achieve Fusion in the rhesus monkey and was the basis for this study (doses of 6-12 mg/ side). Methods. Nine skeletally mature, rhesus macaque monkeys underwent single level posterolateral arthrodesis at L4-L5. Two different rhBMP-2 doses were evaluated in 3 delivery configurations. The first 3 monkeys received 10 mg/side (2.5 mL at 4.0 mg/mL) of rhBMP-2 loadeddirectly onto a CRM carrier (15% hydroxyapatite/85% β-tricalcium phosphate ceramic/collagen matrix), resulting in a final concentration of 2.0 mg/mL. The second 3monkeys received 3 mg/side (2.0 mL at 1.5 mg/mL) of rhBMP-2 loaded directly on the CRM carrier, resulting in a 0.6 mg/mL final concentration. Three additional monkeys also received the 3 mg/side (2.0 mL at 1.5 mg/mL) of rhBMP-2 delivered on an ACS, which was then wrapped around the dry CRM matrix used as a bulking agent, yielding a 1.5 mg/mL final concentration of rhBMP-2 on the sponge wrapped around the bulking agent. The monkeys were euthanized at 24 weeks after surgery. Manual palpation, plain radiographs, computerized tomography, and nondecalcified histology were used to evaluate Fusion in a blinded fashion. Results. The 3 monkeys with 10 mg rhBMP-2 placed directly on the CRM carrier (2.0 mg/mL final concentration) achieved solid Fusion. The 3 monkeys that underwent Fusion with 3 mg of rhBMP-2 placed directly on the CRM carrier (0.6 mg/mL final concentration) failed to achieve Fusion. In contrast, the 3 monkeys that underwent Fusion with the same 3 mg dose of rhBMP-2 dispensed only on an ACS that was wrapped around the CRM achieved solid bilateral Fusion. Conclusions. This study shows the importance of carrier optimization and final implant protein concentration for the successful delivery of rhBMP-2. By combining the properties of the ACS with the CRM, the required dosage of rhBMP-2 was diminished by more than 3-fold in the non-human primate model. This finding suggests that the currently available concentration of rhBMP-2 (1.5 mg/mL) could be successful for achieving posterolateral Spine Fusion when combined with an osteoconductive bulking agent that can support the induced new bone formation.
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use of recombinant human bone morphogenetic protein 2 to achieve posterolateral lumbar Spine Fusion in humans a prospective randomized clinical pilot trial 2002 volvo award in clinical studies
Spine, 2002Co-Authors: Scott D Boden, Harvinder S Sandhu, James D Kang, John G HellerAbstract:Study Design. A prospective randomized clinical study was conducted. Objective. To determine whether the dose and carrier that were successful in rhesus monkeys could induce consistent radiographic Spine Fusion in humans. of Background Data. Preclinical studies have demonstrated that recombinant human bone morphogenetic protein-2 (rhBMP-2), an osteoinductive bone morphogenetic protein, is successful at generating Spine Fusion in rabbits and rhesus monkeys. Methods. For this study, 25 patients undergoing lumbar arthrodesis were randomized (1:2:2 ratio) based on the arthrodesis technique: autograft/Texas Scottish Rite Hospital (TSRH) pedicle screw instrumentation (n = 5), rhBMP-2/TSRH (n = 11), and rhBMP-2 only without internal fixation (n = 9). On each side, 20 mg of rhBMP-2 were delivered on a carrier consisting of 60% hydroxyapatite and 40% tricalcium phosphate granules (10 cm 3 /side). The patients had single-level disc degeneration, Grade 1 or less spondylolisthesis, mechanical low back pain with or without leg pain, and at least 6 months failure of non-operative treatment. Results. All 25 patients were available for follow-up evaluation (mean, 17 months; range 12-27 months). The radiographic Fusion rate was 40% (2/5) in the autograftl TSRH group and 100% (20/20) with rhBMP-2 group with or without TSRH internal fixation (P = 0.004). A statistically significant improvement in Oswestry score was seen at 6 weeks in the rhBMP-2 only group (-17.6; P = 0.009), and at 3 months in the rhBMP-2/TSRH group (-17.0; P = 0.003), but not until 6 months in the autograft/TSRH group (-17.3; P = 0.041). At the final follow-up assessment, Oswestry improvement was greatest in the rhBMP-2 only group (-28.7, P< 0.001). The SF-36 Pain Index and PCS subscales showed similar changes. Discussion. This pilot study is the first with at least 1 year of follow-up evaluation to demonstrate successful posterolateral Spine Fusion using a BMP-based bone graft substitute, with radiographs and CT scans as the determinant. Consistently, rhBMP-2 was able to induce bone in the posterolateral lumbar Spine when delivered at a dose of 20 mg per side with or without the use of internal fixation. Patients with spondylolisthesis classified higher than Meyerding Grade 1 or with more than 5 mm of translational motion may still require internal fixation. Some patients did smoke during the postoperative period, and all in the rhBMP-2 groups still obtained solid Fusions. Conclusions. Consistently, rhBMP-2 with the biphasic calcium phosphate granules induced radiographic posterolateral lumbar Spine Fusion with or without internal fixation in patients whose spondylolisthesis did not exceed Grade 1. Statistically greater and quicker improvement in patient-derived clinical outcome was measured in the rhBMP-2 groups.
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overview of the biology of lumbar Spine Fusion and principles for selecting a bone graft substitute
Spine, 2002Co-Authors: Scott D BodenAbstract:Study Design. Reviews were conducted. Objectives. To review the biology of Spine Fusion healing, and to outline several fundamental principles required for the selection of a bone graft substitute. Summary of Background Data. More than 200,000 Spine Fusions are performed each year in the United States. The success of this procedure is limited by morbidity from iliac crest bone graft harvest and a nonunion rate that ranges from 10% to 40%. In recent years, there has been an increased understanding of the biology of Spine Fusion healing. In addition, there has been a focus on finding suitable substitutes for autogenous iliac crest bone graft to promote Spine Fusion. The selection of a specific bone graft substitute can be a daunting task for the surgeon. Methods. The available literature was reviewed and combined with the author’s personal experience. Results. A basic understanding of the biology of healing in different types of Spine Fusions and the differences between different categories of bone graft substitutes can help surgeons organize the graft selection process. Conclusions. In general, purely osteoconductive substitutes are less effective in adult posterolateral Spine Fusions, but may be suitable in the anterior Spine when it is rigidly immobilized. Osteoinductive substitutes are more likely to be successful as extenders, enhancers, or substi
Steven D Glassman - One of the best experts on this subject based on the ideXlab platform.
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infection risk for primary and revision instrumented lumbar Spine Fusion in the medicare population
Journal of Neurosurgery, 2012Co-Authors: Steven M Kurtz, Leah Y Carreon, Edmund Lau, Kevin L Ong, Heather N Watson, Todd J Albert, Steven D GlassmanAbstract:Object This retrospective analysis of Medicare administrative data was performed to evaluate the risk of infection following instrumented lumbar Fusion over a 10-year follow-up period in the Medicare population. Although infection can be a devastating complication, due to its rarity it is difficult to characterize infection risk except in large patient populations. Methods Using ICD-9-CM and CPT4 procedure codes, the Medicare 5% analytical research files for inpatient, outpatient, and physician carrier claims were checked to identify patients who were treated between 1997 and 2009 with lumbar Spine Fusion in which cages or posterior instrumentation were used. Patients younger than 65 years old were excluded. Patients were followed continuously by using the matching denominator file until they withdrew from Medicare or died. The authors identified 15,069 patients with primary Fusion procedures and 605 with revision of instrumented lumbar Fusion. Infections were identified by the related ICD-9 codes (998.59...
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complications with recombinant human bone morphogenic protein 2 in posterolateral Spine Fusion a consecutive series of 1037 cases
Spine, 2011Co-Authors: Steven D Glassman, John R Dimar, Jennifer M Howard, Alexander Sweet, Greg Wilson, Leah Y CarreonAbstract:STUDY DESIGN Retrospective case series. OBJECTIVE The purpose of this study was to report on a large consecutive series of posterolateral Fusion cases using rhBMP-2/ACS. SUMMARY OF BACKGROUND DATA Despite evidence that rhBMP-2/ACS is effective as an iliac crest graft substitute in posterolateral Fusion, concerns remain regarding potential risk for BMP use in clinical practice. These concerns have been fueled by the serious complications reported with BMP in anterior cervical Spine Fusion. While none of the literature on posterolateral Fusion with rhBMP-2/ACS has suggested an increased complication rate versus iliac crest bone graft, this issue has not been specifically studied. METHODS We reviewed medical records for a consecutive series of 1037 patients who underwent posterolateral Spine Fusion using rhBMP-2 between 2003 and 2006. Medical complications were attributed to the surgical procedure if they occurred within the 3-month perioperative period, whereas complications potentially related to BMP were included regardless of time frame. RESULTS Medical and surgical complications were observed in 190 of 1037 patients (18.3%) with 81 major complications (7.8%) and 110 minor complications (10.2%). Neurologic complications were related to screw malposition in 6 patients and epidural hematoma in 3 patients. New or more severe postoperative radicular symptoms were noted in 7 patients (0.7%). Psoas hematoma was identified by CT scan in 8 patients (0.8%). Complications directly related to rhBMP-2 were observed in at least 1 patient (0.1%) and in a worst case analysis, in as many as 6 patients (0.6%). CONCLUSION This study in 1037 patients confirms the relative safety of rhBMP-2/ACS for posterolateral Spine Fusion. There were extremely few complications directly attributed to rhBMP-2/ACS, and the overall complication rates were consistent with established norms. The stark contrast between this experience and the markedly elevated complication rate reported with anterior cervical BMP usage emphasizes the need to evaluate risks and benefits of bioactive technologies in a site-specific and procedure-specific manner.
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off label use of bone morphogenetic proteins in the united states using administrative data
Spine, 2010Co-Authors: Kevin L Ong, Leah Y Carreon, Steven M Kurtz, Edmund Lau, Marta L Villarraga, Steven D GlassmanAbstract:Study Design. Epidemiological study using national administrative data. Objective. To evaluate the temporal trends in on-label and off-label bone morphogenetic protein (BMP) usage in primary and revision Spine Fusion by Spine region and surgical approach, and nonSpine applications in the United States from 2002 to 2007. Summary of Background Data. The prevalence of BMP usage for Spine Fusion has been on the rise, but its use has not been stratified by surgical approach, particularly for lumbar Fusion where it has only been Food And Drug Administration-approved for anterior lumbar interbody Fusion (ALIF). Methods. The prevalence of BMP usage in the United States was evaluated using the Nationwide Inpatient Sample between October 1, 2002 and December 31, 2007. The Nationwide Inpatient Sample is the single largest all-payer inpatient care database in the United States. The principal procedure associated with BMP use was determined, and the prevalence of BMP use was calculated for various population subgroups. Results. A total of 340,251 inpatient procedures with BMP usage were identified. Between 2003 and 2007, the annual number of procedures involving BMP increased by 4.3-fold from 23,900 to 103,194. Spine Fusion accounted for the vast majority (92.8%) of principal procedures with BMP. The predominant use of BMP was in primary posterior lumbar interbody Fusion or transforaminal lumbar interbody Fusion (PLIF/TLIF) (30.0%), followed by primary posterolateral Spine Fusion (20.4%), primary ALIF (16.6%), primary cervical Fusions (13.6%), and primary thoracolumbar Fusions (3.9%). Of primary ALIF with BMP, 19.3% did not involve the implantation of an interbody device. Conclusion. At least 85% of principal procedures using BMP were for off-label applications. With uncertainty regarding the risks of using BMP in certain off-labelapplications, further research will be needed to better define the appropriate indications. Our study also demonstrates that disparities in the differential rates of BMP use exist in the Spine Fusion population.
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neck disability index short form 36 physical component summary and pain scales for neck and arm pain the minimum clinically important difference and substantial clinical benefit after cervical Spine Fusion
The Spine Journal, 2010Co-Authors: Leah Y Carreon, Steven D Glassman, Mitchell J Campbell, Paul A AndersonAbstract:Abstract Background Context The Neck Disability Index (NDI), the short form-36 (SF-36) physical component summary (PCS), and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical Spine surgery. The minimum clinically important difference (MCID) is a threshold of improvement that is clinically relevant to the patient. However, the true goal is to provide the patient with a substantial clinical benefit (SCB). Purpose This study determines the MCID and SCB using common anchor-based methods for NDI, PCS, and pain scales for arm and neck pain in patients undergoing cervical Spine Fusion for degenerative disorders. Study Design/Setting The study setting is a longitudinal cohort in a multisurgeon Spine specialty clinic. Patient sample The sample comprises 505 patients who underwent a cervical Fusion for degenerative Spine conditions and who have prospectively collected outcome scores with a minimum 1-year follow-up. Outcome Measures The outcome measures of the study were NDI, SF-36, and numeric rating scales for arm and neck pain. Methods The MCID and SCB values for NDI, PCS, and pain scales for arm and neck pain were determined using receiver operating characteristic (ROC) curve analysis with the Health Transition Item of the SF-36 as an anchor. The Health Transition Item asks a patient “Compared to one year ago, how would you rate your health in general now?” with answers ranging from “Much Better,” “Somewhat Better,” “About the Same,” “Somewhat Worse,” to “Much Worse.” An ROC curve was constructed for each measure. The ROC curve–derived MCID was the change score with equal sensitivity and specificity to distinguish the “Somewhat Better” from the “About the Same” patients. The ROC curve–derived SCB was the change score with equal sensitivity and specificity to distinguish the “Much Better” from the “Somewhat Better” patients. Distribution-based methods including the standard error of the mean and the minimum detectable change were also used to calculate MCID. Results The calculated MCID is 7.5 for the NDI, 4.1 for SF-36 PCS, and 2.5 for arm and neck pain. The calculated SCB is 9.5 for the NDI, 6.5 for SF-36 PCS, and 3.5 for arm and neck pain. Conclusions Patients with an eight-point decrease in NDI, a 4.1-point increase in PCS, and a three-point decrease in arm or neck pain can detect a minimally clinically important change. Patients with a 10-point decrease in NDI, a 6.5-point increase in PCS, and a four-point decrease in arm or neck pain can detect an SCB after cervical Spine Fusion.
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rhbmp 2 versus iliac crest bone graft for lumbar Spine Fusion in patients over 60 years of age a cost utility study
Spine, 2009Co-Authors: Leah Y Carreon, Steven D Glassman, Mladen Djurasovic, Mitchell J Campbell, Rolando M Puno, John R Johnson, John R DimarAbstract:Study design Randomized clinical trial. Objective To perform a cost-utility analysis using actual cost data from a randomized clinical trial of patients over 60 years old who underwent posterolateral Fusion using either rhBMP-2/ACS or iliac crest bone graft (ICBG). Summary background data Bone morphogenetic protein has been shown to be an effective bone graft substitute for Spine Fusion. However, a clinical trial-based economic analysis of rhBMP-2/ACS compared with iliac crest bone graft has not been done. Methods Patients over 60 years old requiring decompression and posterolateral Fusion were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). A dedicated hospital coder and research nurse tracked each patient to determine direct costs of inpatient care and all postoperative healthcare encounters up to 2 years after surgery. Preoperative and 2-year-postoperative SF-6D utility scores for each patient were determined. A decision tree was created, which included the probability of complications, need for additional treatments and revision surgery; and the costs associated with initial surgery and treatment for complications and additional treatment for continued Spine symptoms; and utility scores. Results The mean total 2-year cost for care (excluding complication and additional Spine treatment costs) was $34,235 in the ICBG group and $36,530 in the rhBMP-2/ACS group. For the entire group, the mean cost to treat a major complication was $10,888, the cost of revision surgery for nonunion was $46,852, and additional treatment for Spine-related events was $5892. In the ICBG group, 8 patients had complications; 20 had additional interventions, 5 of whom required revision for nonunion. In the rhBMP-2/ACS group, 6 patients had complications, 10 had additional interventions, and 1 required revision for nonunion. The cost of using rhBMP-2/ACS was $39,967 with a 0.11 mean improvement in SF-6D; and for ICBG the cost was $42,286 with a mean improvement of 0.10 in SF-6D. Conclusion There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS. This may account for higher costs and lower improvements in utility seen in patients receiving ICBG compared with rhBMP-2/ACS in this study population.
Leah Y Carreon - One of the best experts on this subject based on the ideXlab platform.
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infection risk for primary and revision instrumented lumbar Spine Fusion in the medicare population
Journal of Neurosurgery, 2012Co-Authors: Steven M Kurtz, Leah Y Carreon, Edmund Lau, Kevin L Ong, Heather N Watson, Todd J Albert, Steven D GlassmanAbstract:Object This retrospective analysis of Medicare administrative data was performed to evaluate the risk of infection following instrumented lumbar Fusion over a 10-year follow-up period in the Medicare population. Although infection can be a devastating complication, due to its rarity it is difficult to characterize infection risk except in large patient populations. Methods Using ICD-9-CM and CPT4 procedure codes, the Medicare 5% analytical research files for inpatient, outpatient, and physician carrier claims were checked to identify patients who were treated between 1997 and 2009 with lumbar Spine Fusion in which cages or posterior instrumentation were used. Patients younger than 65 years old were excluded. Patients were followed continuously by using the matching denominator file until they withdrew from Medicare or died. The authors identified 15,069 patients with primary Fusion procedures and 605 with revision of instrumented lumbar Fusion. Infections were identified by the related ICD-9 codes (998.59...
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complications with recombinant human bone morphogenic protein 2 in posterolateral Spine Fusion a consecutive series of 1037 cases
Spine, 2011Co-Authors: Steven D Glassman, John R Dimar, Jennifer M Howard, Alexander Sweet, Greg Wilson, Leah Y CarreonAbstract:STUDY DESIGN Retrospective case series. OBJECTIVE The purpose of this study was to report on a large consecutive series of posterolateral Fusion cases using rhBMP-2/ACS. SUMMARY OF BACKGROUND DATA Despite evidence that rhBMP-2/ACS is effective as an iliac crest graft substitute in posterolateral Fusion, concerns remain regarding potential risk for BMP use in clinical practice. These concerns have been fueled by the serious complications reported with BMP in anterior cervical Spine Fusion. While none of the literature on posterolateral Fusion with rhBMP-2/ACS has suggested an increased complication rate versus iliac crest bone graft, this issue has not been specifically studied. METHODS We reviewed medical records for a consecutive series of 1037 patients who underwent posterolateral Spine Fusion using rhBMP-2 between 2003 and 2006. Medical complications were attributed to the surgical procedure if they occurred within the 3-month perioperative period, whereas complications potentially related to BMP were included regardless of time frame. RESULTS Medical and surgical complications were observed in 190 of 1037 patients (18.3%) with 81 major complications (7.8%) and 110 minor complications (10.2%). Neurologic complications were related to screw malposition in 6 patients and epidural hematoma in 3 patients. New or more severe postoperative radicular symptoms were noted in 7 patients (0.7%). Psoas hematoma was identified by CT scan in 8 patients (0.8%). Complications directly related to rhBMP-2 were observed in at least 1 patient (0.1%) and in a worst case analysis, in as many as 6 patients (0.6%). CONCLUSION This study in 1037 patients confirms the relative safety of rhBMP-2/ACS for posterolateral Spine Fusion. There were extremely few complications directly attributed to rhBMP-2/ACS, and the overall complication rates were consistent with established norms. The stark contrast between this experience and the markedly elevated complication rate reported with anterior cervical BMP usage emphasizes the need to evaluate risks and benefits of bioactive technologies in a site-specific and procedure-specific manner.
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off label use of bone morphogenetic proteins in the united states using administrative data
Spine, 2010Co-Authors: Kevin L Ong, Leah Y Carreon, Steven M Kurtz, Edmund Lau, Marta L Villarraga, Steven D GlassmanAbstract:Study Design. Epidemiological study using national administrative data. Objective. To evaluate the temporal trends in on-label and off-label bone morphogenetic protein (BMP) usage in primary and revision Spine Fusion by Spine region and surgical approach, and nonSpine applications in the United States from 2002 to 2007. Summary of Background Data. The prevalence of BMP usage for Spine Fusion has been on the rise, but its use has not been stratified by surgical approach, particularly for lumbar Fusion where it has only been Food And Drug Administration-approved for anterior lumbar interbody Fusion (ALIF). Methods. The prevalence of BMP usage in the United States was evaluated using the Nationwide Inpatient Sample between October 1, 2002 and December 31, 2007. The Nationwide Inpatient Sample is the single largest all-payer inpatient care database in the United States. The principal procedure associated with BMP use was determined, and the prevalence of BMP use was calculated for various population subgroups. Results. A total of 340,251 inpatient procedures with BMP usage were identified. Between 2003 and 2007, the annual number of procedures involving BMP increased by 4.3-fold from 23,900 to 103,194. Spine Fusion accounted for the vast majority (92.8%) of principal procedures with BMP. The predominant use of BMP was in primary posterior lumbar interbody Fusion or transforaminal lumbar interbody Fusion (PLIF/TLIF) (30.0%), followed by primary posterolateral Spine Fusion (20.4%), primary ALIF (16.6%), primary cervical Fusions (13.6%), and primary thoracolumbar Fusions (3.9%). Of primary ALIF with BMP, 19.3% did not involve the implantation of an interbody device. Conclusion. At least 85% of principal procedures using BMP were for off-label applications. With uncertainty regarding the risks of using BMP in certain off-labelapplications, further research will be needed to better define the appropriate indications. Our study also demonstrates that disparities in the differential rates of BMP use exist in the Spine Fusion population.
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neck disability index short form 36 physical component summary and pain scales for neck and arm pain the minimum clinically important difference and substantial clinical benefit after cervical Spine Fusion
The Spine Journal, 2010Co-Authors: Leah Y Carreon, Steven D Glassman, Mitchell J Campbell, Paul A AndersonAbstract:Abstract Background Context The Neck Disability Index (NDI), the short form-36 (SF-36) physical component summary (PCS), and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical Spine surgery. The minimum clinically important difference (MCID) is a threshold of improvement that is clinically relevant to the patient. However, the true goal is to provide the patient with a substantial clinical benefit (SCB). Purpose This study determines the MCID and SCB using common anchor-based methods for NDI, PCS, and pain scales for arm and neck pain in patients undergoing cervical Spine Fusion for degenerative disorders. Study Design/Setting The study setting is a longitudinal cohort in a multisurgeon Spine specialty clinic. Patient sample The sample comprises 505 patients who underwent a cervical Fusion for degenerative Spine conditions and who have prospectively collected outcome scores with a minimum 1-year follow-up. Outcome Measures The outcome measures of the study were NDI, SF-36, and numeric rating scales for arm and neck pain. Methods The MCID and SCB values for NDI, PCS, and pain scales for arm and neck pain were determined using receiver operating characteristic (ROC) curve analysis with the Health Transition Item of the SF-36 as an anchor. The Health Transition Item asks a patient “Compared to one year ago, how would you rate your health in general now?” with answers ranging from “Much Better,” “Somewhat Better,” “About the Same,” “Somewhat Worse,” to “Much Worse.” An ROC curve was constructed for each measure. The ROC curve–derived MCID was the change score with equal sensitivity and specificity to distinguish the “Somewhat Better” from the “About the Same” patients. The ROC curve–derived SCB was the change score with equal sensitivity and specificity to distinguish the “Much Better” from the “Somewhat Better” patients. Distribution-based methods including the standard error of the mean and the minimum detectable change were also used to calculate MCID. Results The calculated MCID is 7.5 for the NDI, 4.1 for SF-36 PCS, and 2.5 for arm and neck pain. The calculated SCB is 9.5 for the NDI, 6.5 for SF-36 PCS, and 3.5 for arm and neck pain. Conclusions Patients with an eight-point decrease in NDI, a 4.1-point increase in PCS, and a three-point decrease in arm or neck pain can detect a minimally clinically important change. Patients with a 10-point decrease in NDI, a 6.5-point increase in PCS, and a four-point decrease in arm or neck pain can detect an SCB after cervical Spine Fusion.
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rhbmp 2 versus iliac crest bone graft for lumbar Spine Fusion in patients over 60 years of age a cost utility study
Spine, 2009Co-Authors: Leah Y Carreon, Steven D Glassman, Mladen Djurasovic, Mitchell J Campbell, Rolando M Puno, John R Johnson, John R DimarAbstract:Study design Randomized clinical trial. Objective To perform a cost-utility analysis using actual cost data from a randomized clinical trial of patients over 60 years old who underwent posterolateral Fusion using either rhBMP-2/ACS or iliac crest bone graft (ICBG). Summary background data Bone morphogenetic protein has been shown to be an effective bone graft substitute for Spine Fusion. However, a clinical trial-based economic analysis of rhBMP-2/ACS compared with iliac crest bone graft has not been done. Methods Patients over 60 years old requiring decompression and posterolateral Fusion were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). A dedicated hospital coder and research nurse tracked each patient to determine direct costs of inpatient care and all postoperative healthcare encounters up to 2 years after surgery. Preoperative and 2-year-postoperative SF-6D utility scores for each patient were determined. A decision tree was created, which included the probability of complications, need for additional treatments and revision surgery; and the costs associated with initial surgery and treatment for complications and additional treatment for continued Spine symptoms; and utility scores. Results The mean total 2-year cost for care (excluding complication and additional Spine treatment costs) was $34,235 in the ICBG group and $36,530 in the rhBMP-2/ACS group. For the entire group, the mean cost to treat a major complication was $10,888, the cost of revision surgery for nonunion was $46,852, and additional treatment for Spine-related events was $5892. In the ICBG group, 8 patients had complications; 20 had additional interventions, 5 of whom required revision for nonunion. In the rhBMP-2/ACS group, 6 patients had complications, 10 had additional interventions, and 1 required revision for nonunion. The cost of using rhBMP-2/ACS was $39,967 with a 0.11 mean improvement in SF-6D; and for ICBG the cost was $42,286 with a mean improvement of 0.10 in SF-6D. Conclusion There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS. This may account for higher costs and lower improvements in utility seen in patients receiving ICBG compared with rhBMP-2/ACS in this study population.
John R Dimar - One of the best experts on this subject based on the ideXlab platform.
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complications with recombinant human bone morphogenic protein 2 in posterolateral Spine Fusion a consecutive series of 1037 cases
Spine, 2011Co-Authors: Steven D Glassman, John R Dimar, Jennifer M Howard, Alexander Sweet, Greg Wilson, Leah Y CarreonAbstract:STUDY DESIGN Retrospective case series. OBJECTIVE The purpose of this study was to report on a large consecutive series of posterolateral Fusion cases using rhBMP-2/ACS. SUMMARY OF BACKGROUND DATA Despite evidence that rhBMP-2/ACS is effective as an iliac crest graft substitute in posterolateral Fusion, concerns remain regarding potential risk for BMP use in clinical practice. These concerns have been fueled by the serious complications reported with BMP in anterior cervical Spine Fusion. While none of the literature on posterolateral Fusion with rhBMP-2/ACS has suggested an increased complication rate versus iliac crest bone graft, this issue has not been specifically studied. METHODS We reviewed medical records for a consecutive series of 1037 patients who underwent posterolateral Spine Fusion using rhBMP-2 between 2003 and 2006. Medical complications were attributed to the surgical procedure if they occurred within the 3-month perioperative period, whereas complications potentially related to BMP were included regardless of time frame. RESULTS Medical and surgical complications were observed in 190 of 1037 patients (18.3%) with 81 major complications (7.8%) and 110 minor complications (10.2%). Neurologic complications were related to screw malposition in 6 patients and epidural hematoma in 3 patients. New or more severe postoperative radicular symptoms were noted in 7 patients (0.7%). Psoas hematoma was identified by CT scan in 8 patients (0.8%). Complications directly related to rhBMP-2 were observed in at least 1 patient (0.1%) and in a worst case analysis, in as many as 6 patients (0.6%). CONCLUSION This study in 1037 patients confirms the relative safety of rhBMP-2/ACS for posterolateral Spine Fusion. There were extremely few complications directly attributed to rhBMP-2/ACS, and the overall complication rates were consistent with established norms. The stark contrast between this experience and the markedly elevated complication rate reported with anterior cervical BMP usage emphasizes the need to evaluate risks and benefits of bioactive technologies in a site-specific and procedure-specific manner.
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rhbmp 2 versus iliac crest bone graft for lumbar Spine Fusion in patients over 60 years of age a cost utility study
Spine, 2009Co-Authors: Leah Y Carreon, Steven D Glassman, Mladen Djurasovic, Mitchell J Campbell, Rolando M Puno, John R Johnson, John R DimarAbstract:Study design Randomized clinical trial. Objective To perform a cost-utility analysis using actual cost data from a randomized clinical trial of patients over 60 years old who underwent posterolateral Fusion using either rhBMP-2/ACS or iliac crest bone graft (ICBG). Summary background data Bone morphogenetic protein has been shown to be an effective bone graft substitute for Spine Fusion. However, a clinical trial-based economic analysis of rhBMP-2/ACS compared with iliac crest bone graft has not been done. Methods Patients over 60 years old requiring decompression and posterolateral Fusion were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). A dedicated hospital coder and research nurse tracked each patient to determine direct costs of inpatient care and all postoperative healthcare encounters up to 2 years after surgery. Preoperative and 2-year-postoperative SF-6D utility scores for each patient were determined. A decision tree was created, which included the probability of complications, need for additional treatments and revision surgery; and the costs associated with initial surgery and treatment for complications and additional treatment for continued Spine symptoms; and utility scores. Results The mean total 2-year cost for care (excluding complication and additional Spine treatment costs) was $34,235 in the ICBG group and $36,530 in the rhBMP-2/ACS group. For the entire group, the mean cost to treat a major complication was $10,888, the cost of revision surgery for nonunion was $46,852, and additional treatment for Spine-related events was $5892. In the ICBG group, 8 patients had complications; 20 had additional interventions, 5 of whom required revision for nonunion. In the rhBMP-2/ACS group, 6 patients had complications, 10 had additional interventions, and 1 required revision for nonunion. The cost of using rhBMP-2/ACS was $39,967 with a 0.11 mean improvement in SF-6D; and for ICBG the cost was $42,286 with a mean improvement of 0.10 in SF-6D. Conclusion There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS. This may account for higher costs and lower improvements in utility seen in patients receiving ICBG compared with rhBMP-2/ACS in this study population.
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rhbmp 2 versus iliac crest bone graft for lumbar Spine Fusion a randomized controlled trial in patients over sixty years of age
Spine, 2008Co-Authors: Steven D Glassman, Leah Y Carreon, Mladen Djurasovic, Mitchell J Campbell, Rolando M Puno, John R Johnson, John R DimarAbstract:Study Design. Prospective randomized controlled trial of rhBMP-2/ACS (Infuse bone graft) versus iliac crest bone graft (ICBG) for lumbar Spine Fusion in patients over 60 years of age. Objective. To report on clinical, radiographic, and economic outcomes, at 2-year follow-up, in patients treated by posterolateral lumbar Fusion with rhBMP-2/ACS versus ICBG. Summary of Background Data. RhBMP-2/ACS is widely used "off-label" for posterolateral spinal Fusion. Despite encouraging initial reports, outstanding issues include the need for evidence regarding safety and efficacy in an older population; and an assessment of cost-effectiveness. Methods. Patients over 60 years old were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). Oswestry Disability Index, Short Form-36, and numerical rating scales for back and leg pain were determined preoperatively and at 6, 12, and 24 months postoperatively. Fusion was evaluated by fine-cut computed tomography scan 2 years postoperatively by 3 reviewers. All in-patient and subsequent out-patient event costs were recorded by a dedicated hospital coder. Results. Two-year postoperative improvement in Oswestry Disability Index averaged 15.8 in the rhBMP-2/ACS group and 13.0 in the ICBG group. Mean improvement in Short Form-36 physical component score was 6.6 in the rhBMP-2/ACS group and 7.5 in the ICBG group. There were 20 complications in the ICBG group and 8 complications in the rhBMP-2/ACS group (P = 0.014). Sixteen ICBG and 10 rhBMP-2/ACS patients required additional treatment for persistent back or leg symptoms. Two rh-BMP-2/ACS patients had revision procedures, 1 for nonunion. Eight patients in the ICBG group had revision procedures, 5 for nonunion. Mean Fusion grade on computed tomography scan was significantly (P = 0.030) better in the rhBMP-2/ACS (4.3) compared with the ICBG group (3.8). Mean cost of the initial admission was $36,530 in the rhBMP-2/ACS group and $34,235 in the iliac crest bone graft (ICBG) group. Total cost of care over 2 years was $42,574 for the ICBG group and $40,131 for the rhBMP-2/ ACS group. Conclusion. RhBMP-2/ACS is a viable ICBG replacement in older patients in terms of safety, clinical efficacy, and cost-effectiveness.
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the perioperative cost of infuse bone graft in posterolateral lumbar Spine Fusion
The Spine Journal, 2008Co-Authors: Steven D Glassman, Leah Y Carreon, Mladen Djurasovic, Mitchell J Campbell, Rolando M Puno, John R Johnson, John R DimarAbstract:Abstract Background context There is mounting evidence supporting the efficacy of bone morphogenetic protein (BMP) for both anterior interbody and posterolateral lumbar Fusion. However, the relative cost of BMP remains an important concern for physicians, hospitals, and payers. Purpose The purpose of this study is to report on the perioperative costs for patients treated with rhBMP-2 as compared with an iliac crest bone graft (ICBG) supplemented with graft extenders. Study design/setting A prospective randomized controlled trial of rhBMP-2/ACS (Infuse Bone Graft; Medtronic Sofamor Danek, Memphis, TN) versus ICBG±graft extender for lumbar Spine Fusion in patients over 60 years old. Patient sample One hundred two patients over 60 years old who required a posterolateral lumbar Spine Fusion randomized between receiving rhBMP-2/ACS or ICBG. Outcome measures All health-care costs over the first 3 months after surgery. Methods As part of a prospective randomized trial of rhBMP-2/ACS versus ICBG±graft extender for lumbar Spine Fusion, all costs over the first 3 months after surgery were directly recorded by a dedicated coder funded by Norton Healthcare, Louisville, KY. A dedicated research nurse also followed all patients throughout their hospital stay and posthospitalization recovery to identify any adverse events or additional outpatient medical care. Results Fifty patients received rhBMP-2/ACS and 52 underwent ICBG harvest. The mean hospital cost for the index admission was $24,736 for the rhBMP-2/ACS group and $21,138 for the ICBG group. Mean inpatient physician costs were $5,082 in the rhBMP-2/ACS group and $5,316 in the ICBG group. Costs associated with posthospital rehabilitation averaged $4,906 in the rhBMP-2/ACS group versus $6,820 in the ICBG group. Total payer expenditure for the 3-month perioperative period averaged $33,860 in the rhBMP-2/ACS group and $37,227 in the ICBG group. Conclusions The hospital carries the cost burden associated with the utilization of rhBMP-2/ACS. In contrast, the payer in a Diagnosis-Related Group (DRG) model achieves a net savings, based primarily on the decreased payment for inpatient rehabilitation, but also on decreased hospital reimbursement, physician costs, and other outpatient services.
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posterolateral lumbar Spine Fusion with infuse bone graft
The Spine Journal, 2007Co-Authors: Steven D Glassman, Leah Y Carreon, Mladen Djurasovic, Mitchell J Campbell, Rolando M Puno, John R Johnson, John R DimarAbstract:Abstract Background context INFUSE has been proven effective in conjunction with threaded cages and bone dowels for single-level anterior lumbar interbody Fusion (ALIF). The published experience with posterolateral Fusion, although encouraging, utilizes a significantly higher dose and concentration of recombinant human bone morphogenic protein-2 (rhBMP-2) and a different carrier than the commercially available INFUSE. Purpose To present an assessment of Fusion rate for posterolateral Spine Fusion with INFUSE Bone Graft. Study design/setting Retrospective review of patients treated using INFUSE in posterolateral Spine Fusion in a single institution. Patient sample 91 patients with minimum 2-year follow-up who underwent posterolateral Spine Fusion using INFUSE as an iliac crest bone graft (ICBG) substitute. Outcome measures Fusion rate based on fine-cut computed tomographic (CT) scans with sagittal and coronal reconstructions. Methods Fusion was performed using one large INFUSE kit (12 mg rhBMP-2, 1.5 mg/mL), which was prepared according to the manufacturer's instructions. The INFUSE sponge was wrapped around the local bone or graft extender and placed over the decorticated surfaces in the lateral gutters. Postoperative CT scans with reconstructions were reviewed by two independent orthopedic Spine surgeons. CT scans of a comparison group of 35 patients who underwent primary single-level posterolateral Fusion with ICBG were also reviewed. Results The overall group had a mean 4.38 CT Fusion grade and a 6.6% nonunion rate. Primary one-level Fusion cases (n=48) had a mean 4.42 Fusion grade a 4.2% nonunion rate. Primary multilevel Fusions (n=27) had a mean 4.65 CT grade and no nonunions detected. Assessment of the 35 primary one-level ICBG control cases demonstrated a mean CT grade of 4.35 and a nonunion rate of 11.4%. In the 16 cases of revision for prior nonunion, mean CT grade was 3.81 and 4 subjects had nonunions. Additional subgroup analysis showed that smokers (n=14) had a mean 4.32 CT grade with no nonunions. Men had a mean 4.04 CT grade and an 11.1% nonunion rate compared with a mean 4.61 CT grade and 3.6% nonunion rate in women. This difference was statistically significant (p=.036). No significant differences in Fusion rate were observed based upon the specific graft extender used (p=.200). Conclusions 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. Historically, only ICBG has been able to overcome these challenges and reliably generate a successful posterolateral lumbar Spine Fusion. In contrast to prior studies, clinically available INFUSE delivers only 12 mg rhBMP-2 at a concentration of 1.5 mg/mL. 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. As with ICBG, development of solid Fusion or nonunion is a multifactorial process. The use of INFUSE is not a substitute for proper surgical technique or optimization of patient-related risk factors. Additional studies are needed to determine the incremental benefit of a greater rhBMP-2 dose or use of alternative carriers for posterolateral Fusion. Finally, correlation between radiographic findings and clinical outcomes, and a cost-benefit analysis are needed. 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.
Stefan Schaeren - One of the best experts on this subject based on the ideXlab platform.
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platelet concentrates in Spine Fusion meta analysis of union rates and complications in controlled trials
European Spine Journal, 2016Co-Authors: Julia Vavken, Patrick Vavken, Alexander Mameghani, Carlo Camathias, Stefan SchaerenAbstract:Purpose Platelet concentrates in Spine Fusion gained increasing popularity among Spine surgeons. They avoid morbidity of bone harvest and promise good union rates without additional device-related adverse events. Therefore, they seem to be a safe and effective alternative to common bone substitutes. This meta-analysis assesses the available evidence for union rate and overall complications with the use of platelet concentrates in Spine Fusion.
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union rate and complications in Spine Fusion with recombinant human bone morphogenetic protein 7 systematic review and meta analysis
Global Spine Journal, 2016Co-Authors: Julia Vavken, Patrick Vavken, Alexander Mameghani, Stefan SchaerenAbstract:Study Design Systematic review and meta-analysis. Objective The objective of this meta-analysis was to evaluate the current best evidence to assess effectiveness and safety of recombinant human bone morphogenetic protein-7 (rhBMP-7) as a biological stimulant in Spine Fusion. Methods Studies were included if they reported on outcomes after Spine Fusion with rhBMP-7. The data was synthesized using Mantel-Haenszel pooled risk ratios (RRs) with 95% confidence intervals (CIs). Main end points were union rate, overall complications, postoperative back and leg pain, revision rates, and new-onset cancer. Results Our search produced 796 studies, 6 of which were eligible for inclusion. These studies report on a total of 442 patients (328 experimental, 114 controls) with a mean age of 59 ± 11 years. Our analysis showed no statistically significant differences in union rates (RR 0.97, 95% CI 0.84 to 1.11, p = 0.247), overall complications (RR 0.92, 95% CI 0.71 to 1.20, p = 0.545), postoperative back and leg pain (RR 1.03, 95% CI 0.48 to 2.19, p = 0.941), or revision rate (RR 0.81, 95% CI 0.47 to 1.40, p = 0.449). There was a mathematical indicator of increased tumor rates, but with only one case, the clinical meaningfulness of this finding is questionable. Conclusion We were not able to find data in support of the use of rhBMP-7 for Spine Fusion. We found no evidence for increased complication or revision rates with rhBMP-7. On the other hand, we also found no evidence in support of improved union rates.
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Complications and cancer rates in Spine Fusion with recombinant human bone morphogenetic protein-2 (rhBMP-2).
European Spine Journal, 2015Co-Authors: Julia Vavken, Patrick Vavken, Alexander Mameghani, Stefan SchaerenAbstract:To quantitatively synthesize the available best evidence for general complications, heterotopic ossification (HO), retrograde ejaculation, cervical swelling, and cancer rates with the use of rhBMP-2 in lumbar and cervical Spine Fusion. We conducted an online search for relevant controlled trials and extracted data on the abovementioned endpoints. Studies were eligible for inclusion if they reported on spinal Fusion with rhBMP-2 in humans. Publication bias and heterogeneity were assessed mathematically. These data were synthesized in a meta-analysis using DerSimonian–Laird random effects modeling to calculate pooled odds ratios. We identified 26 studies reporting on a total of 184,324 patients (28,815 experimental, 155,509 controls) with a mean age of 51.1 ± 1.8 years. There was a significantly higher risk of general complications with rhBMP-2 compared to iliac crest bone graft (ICBG) with an odds ratio (OR) of 1.78 (95 %CI 1.20–2.63), (p = 0.004). The odds ratio for HO was 5.57 (95 %CI 1.90–16.36), (p = 0.002), for retrograde ejaculation 3.31 (95 %CI 1.20–9.09), (p = 0.020), and for cervical swelling 4.72 (95 %CI 1.42–15.67), (p = 0.011), all significantly higher in the rhBMP-2 group. The pooled odds ratio for new onset of tumor was 1.35 (95 %CI 0.93–1.96), which represents no statistically significant difference between the groups (p = 0.111). rhBMP-2 is associated with a higher rate of general complications as well as retrograde ejaculation, HO, and cervical tissue swelling in Spine Fusion. There is a slightly increased risk of new onset of tumors, however, without statistical significance.
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Complications and Cancer Rates in Spine Fusion with Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)
The Spine Journal, 2015Co-Authors: Julia Vavken, Patrick Vavken, Alexander Mameghani, Stefan SchaerenAbstract:Purpose To quantitatively synthesize the available best evidence for general complications, heterotopic ossification (HO), retrograde ejaculation, cervical swelling, and cancer rates with the use of rhBMP-2 in lumbar and cervical Spine Fusion.
