scholarly journals Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) for the Treatment of Nonunion of the Femur in Children and Adolescents: A Retrospective Analysis

2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
Tim N. Hissnauer ◽  
Norbert Stiel ◽  
Kornelia Babin ◽  
Martin Rupprecht ◽  
Karsten Ridderbusch ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Locking Plate ◽  
Weight Bearing ◽  
Major Complication ◽  
Deep Infection ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Background. The aim of this study was to examine clinical and radiographic healing after rhBMP-2 application in children and adolescents presenting with nonunion of the femur and to investigate the safety of rhBMP-2 use in these cases. Materials and Methods. We reviewed the medical records of five patients with a mean age of 11 years (5.4 to 16.2) with nonunion of the femur who were treated with rhBMP-2 and internal fixation using a locking plate at a single institution. Particular attention was paid to identify all adverse events that may be due to rhBMP-2 use. Results. Union occurred in four of five patients at a mean of 12.1 months (7.9 to 18.9). The locking plates were removed after a mean of 16 months (11 to 23). One patient had nonunion due to deep infection. After a mean follow-up of 62.5 months (17 to 100), union was still evident in all four patients and they were fully weight-bearing without pain. Discussion. In this retrospective study, rhBMP-2 combined with a locking plate has been used successfully to treat children and adolescents with nonunion of the femur in four of five cases. One major complication was thought to be possibly related to its use.

scholarly journals A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B. McLean ◽  
Mark A. Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch
Keyword(s):  
Lumbar Fusion ◽  
Bone Allograft ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Initial Procedure ◽  
Cellular Bone ◽  
Recombinant Human Bone ◽  
Cellular Bone Allograft

Abstract Background The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed. Methods A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.66%) patients had follow-up re-admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially relevant re-admissions during the 12-month follow-up period. Results The adjusted mean initial procedure and 12-month follow-up hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P < 0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P < 0.0001). The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P < 0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12-month follow-up period (7.87 versus 7.46 days, respectively; P < 0.0001). Differences in rates of follow-up re-admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes. Conclusions The results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

scholarly journals Outcome of nonunion fractures in dogs treated with fixation, compression resistant matrix, and recombinant human bone morphogenetic protein-2

2017 ◽  
Vol 30 (02) ◽  
pp. 153-159 ◽  
Author(s):  
Anna Massie ◽  
Mark Fuller ◽  
Frank Verstraete ◽  
Boaz Arzi ◽  
Amy Kapatkin
Keyword(s):  
Bone Morphogenetic Protein ◽  
Bone Fractures ◽  
Perioperative Complications ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Long Bone ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

SummaryObjectives: To report the use of compression resistant matrix (CRM) infused with recombinant human bone morphogenetic protein (rhBMP-2) prospectively in the healing of non union long-bone fractures in dogs.Methods: A longitudinal cohort of dogs that were presented with nonunion fractures were classified and treated with CRM soaked with rhBMP-2 and fracture fixation. They were followed with serial radiographs and evaluated for healing times and complications according to the time frame and definitions previously established for orthopaedic clinical cases.Results: Eleven nonunion fractures in nine dogs were included. Median healing time was 10 weeks (range: 7–20 weeks). Major perioperative complications due to bandage morbidity were encountered in two of 11 limbs and resolved. All other complications were minor. They occurred perioperatively in eight of 11 limbs. Minor follow-up complications included short-term in one of two limbs, mid-term in one of three, and long-term in four of five limbs. Nine limbs returned to full function and two limbs returned to acceptable function at the last follow-up.Clinical significance: Nonunion fractures given a poor prognosis via standard-of-care treatment were successfully repaired using CRM with rhBMP-2 accompanying fixation. These dogs, previously at high risk of failure, returned to full or acceptable function.

The safety and efficacy of anterior cervical discectomy and fusion with polyetheretherketone spacer and recombinant human bone morphogenetic protein–2: a review of 200 patients

2008 ◽  
Vol 8 (6) ◽  
pp. 529-535 ◽  
Author(s):  
Luis M. Tumialán ◽  
Jeff Pan ◽  
Gerald E. Rodts ◽  
Praveen V. Mummaneni
Keyword(s):  
Bone Morphogenetic Protein ◽  
Clinical Outcomes ◽  
Collagen Sponge ◽  
Bone Morphogenetic Protein 2 ◽  
Ct Scans ◽  
Safety And Efficacy ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Object The goal in this study was to demonstrate the safety and efficacy of anterior cervical discectomy and fusion ([ACDF]; single- or multilevel procedure) performed using titanium plates and polyetheretherketone (PEEK) spacers filled with recombinant human bone morphogenetic protein–2 (rhBMP-2) impregnated in a type I collagen sponge to achieve fusion. Methods The authors retrospectively reviewed 200 patients who underwent a single- or multilevel ACDF with titanium plate fixation and PEEK spacer filled with a collagen sponge impregnated with low-dose rhBMP-2. Clinical outcomes were assessed using pre- and postoperative Nurick grades and the Odom criteria. Radiographic outcomes were assessed using dynamic radiographs and computed tomography (CT) scans. Results The follow-up period ranged from 8 to 36 months (mean 16.7 months). A single-level ACDF was performed in 96 patients, 2-level ACDF in 62 patients, 3-level ACDF in 36 patients, and 4-level ACDF in 6 patients. Long-term follow-up was available for 193 patients. The Odom outcomes were rated as good to excellent in 165 patients (85%), fair in 24 (12.4%), and poor in 4 (2%). Among patients with myelopathy, Nurick grades improved from a preoperative mean of 1.42 to a postoperative mean of 0.26. All patients (100%) achieved solid radiographic fusion on dynamic radiographs and CT scans. Fourteen patients (7%) in this series experienced clinically significant dysphagia, and 4 (2%) required repeated operation for hematoma or seroma. Conclusions An ACDF performed using a PEEK spacer filled with rhBMP-2 leads to good to excellent clinical outcomes and solid fusion, even in multilevel cases and in patients who are smokers. The incidence of symptomatic dysphagia may be decreased with a lower dose of rhBMP-2 that is placed only within the PEEK spacer.

scholarly journals A Large Database Study of Hospitalization Charges and Follow-up Re-admissions in US Lumbar Fusion Surgeries Using a Cellular Bone Allograft (CBA) versus Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

2020 ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B McLean ◽  
Mark A Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch
Keyword(s):  
Lumbar Fusion ◽  
Bone Allograft ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Initial Procedure ◽  
Cellular Bone ◽  
Recombinant Human Bone ◽  
Cellular Bone Allograft

Abstract BackgroundThe objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially-relevant re-admissions during the follow-up period were also assessed.MethodsA total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3,503 (21.66%) patients had follow-up re‑admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially-relevant readmissions during the 12‑month follow-up‑ period.ResultsThe adjusted mean initial procedure and 12-month follow-up‑ hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P<0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P<0.0001).The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P<0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12‑month follow-up period (7.87 versus 7.46 days, respectively; P<0.0001). Differences in rates of follow-up re‑admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA‑ patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes.ConclusionsThe results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

scholarly journals A Large Database Study of Hospitalization Charges and Follow-up Re-admissions in Us Lumbar Fusion Surgeries Using a Cellular Bone Allograft (CBA) Versus Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

2020 ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B McLean ◽  
Mark A Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch
Keyword(s):  
Lumbar Fusion ◽  
Bone Allograft ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Initial Procedure ◽  
Cellular Bone ◽  
Recombinant Human Bone ◽  
Cellular Bone Allograft

Abstract BackgroundThis retrospective study of a large US healthcare system database compared initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP‑2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V‑CBA). Potentially-relevant re-admissions during the follow-up period were also assessed.MethodsA total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3,503 (21.66%) patients had follow-up re‑admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially-relevant re‑admissions during the 12‑month follow‑up period.ResultsThe adjusted mean initial procedure and 12-month follow‑up hospital charges were significantly lower in the V-CBA group versus the rhBMP‑2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P<0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V‑CBA = $103,064, rhBMP-2 = $149,620; P<0.0001).The adjusted mean initial LOS were significantly lower in the V‑CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P<0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12‑month follow-up period (7.87 versus 7.46 days, respectively; P<0.0001). Differences in rates of follow-up re‑admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V‑CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes.ConclusionsThe results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

scholarly journals Recombinant Human Bone Morphogenetic Protein–2 Use in Adult Spinal Deformity Surgery: Comparative Analysis and Healthcare Utilization at 24 Months’ Follow-up

2020 ◽  
pp. 219256822094737
Author(s):  
Nicholas Dietz ◽  
Mayur Sharma ◽  
Michael Kelly ◽  
Beatrice Ugiliweneza ◽  
Dengzhi Wang ◽  
...  
Keyword(s):  
Health Care ◽  
Spinal Deformity ◽  
Adult Spinal Deformity ◽  
Bone Morphogenetic Protein 2 ◽  
Index Hospitalization ◽  
Outpatient Services ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Study Design: Retrospective cohort study. Objective: Recombinant human bone morphogenetic protein–2 (rhBMP-2) is used to achieve fusion in adult spinal deformity (ASD) surgery. Our aim was to investigate the long-term impact of rhBMP-2 use for clinical outcomes and health care utilization in this patient population. Methods: We conducted an analysis using MarketScan to identify health resource utilization of rhBMP-2 use for ASD after surgical intervention compared to fusion without rhBMP-2 at 24 months’ follow-up. Outcomes assessed included length of stay, complications, pseudoarthrosis, reoperation, outpatient services, and health care payments. Results: Of 7115 patients who underwent surgery for ASD, 854 received rhBMP-2 and 6261 were operated upon without use of rhBMP-2. One month after discharge, the rhBMP-2 cohort had a nonsignificant trend in fewer complications (15.38%) than those who did not receive rhBMP-2 (18.07%), P = .0558. At 12 months, pseudoarthrosis was reported in 2.8% of cases with no BMP and 01.14% of cases with BMP, P = .0048. Average payments at 12 months were $120 138 for the rhBMP-2 group and $118 373 for the no rhBMP-2 group, P = .8228. At 24 months, payments were $141 664 for the rhBMP-2 group and $144 179 for the group that did not receive rhBMP-2, P = .5946. Conclusions: In ASD surgery, use of rhBMP-2 was not associated with increased complications or reoperations at index hospitalization and 1-month follow-up. Overall payments, including index hospitalization, readmissions, reoperations, and outpatient services were not different compared to those without the use of rhBMP-2 at 12 months and 24 months after discharge.

Blood Serum Antibody Analysis and Long-Term Follow-up of Patients Treated With Recombinant Human Bone Morphogenetic Protein-2 in the Lumbar Spine

Spine ◽  
2011 ◽  
Vol 36 (25) ◽  
pp. 2158-2167 ◽  
Author(s):  
J. Kenneth Burkus ◽  
Matthew F. Gornet ◽  
Steven D. Glassman ◽  
Paul J. Slosar ◽  
Michael K. Rosner ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Blood Serum ◽  
Serum Antibody ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Long Term Follow Up ◽  
Recombinant Human Bone

scholarly journals Routine use of recombinant human bone morphogenetic protein–2 in posterior fusions of the pediatric spine and incidence of cancer

2015 ◽  
Vol 16 (1) ◽  
pp. 4-13 ◽  
Author(s):  
Christina Sayama ◽  
Matthew Willsey ◽  
Murali Chintagumpala ◽  
Alison Brayton ◽  
Valentina Briceño ◽  
...  
Keyword(s):  
Cancer Risk ◽  
Bone Morphogenetic Protein ◽  
Pediatric Population ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Lumbosacral Spine ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

OBJECT The aim of this study was to determine the safety of recombinant human bone morphogenetic protein–2 (rhBMP-2) use in posterior instrumented fusions in the pediatric population, focusing on cancer risk. In a previous study, the authors reported the short-term (mean follow-up of 11 months) safety and efficacy of rhBMP-2 in the pediatric age group. The present study reports their results with a minimum of 24 months' follow-up. METHODS The authors retrospectively reviewed 57 consecutive cases involving pediatric patients who underwent posterior occiptocervical, cervical, thoracic, lumbar, or lumbosacral spine fusion from October 1, 2007, to June 30, 2011, at Texas Children's Hospital. Seven cases were excluded from further analysis because of loss to follow-up. Three patients died during the follow-up period and were placed in a separate cohort. RESULTS The patients' average age at the time of surgery was 11 years, 4 months (range 9 months to 20 years). The mean duration of follow-up was 48.4 months (range 24–70 months). Cancer status was determined at the most recent encounter with the patient and/or caretaker(s) in person, or in telephone follow-up. Twenty-four or more months after administration of rhBMP-2, there were no cases of new malignancy, degeneration, or metastasis of existing tumors. The cause of death of the patients who died during the study period was not related to BMP or to the development, degeneration, or metastasis of cancer. CONCLUSIONS Despite the large number of adult studies reporting increased cancer risk associated with BMP use, the authors' outcomes with rhBMP-2 in the pediatric population suggest that it is a safe adjunct to posterior spine fusions of the occipitocervical, cervical, thoracic, lumbar, and lumbosacral spine. There were no new cases of cancer, or degeneration or metastasis of existing malignancies in this series.

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