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 The efficacy of routine use of recombinant human bone morphogenetic protein–2 in occipitocervical and atlantoaxial fusions of the pediatric spine: a minimum of 12 months' follow-up with computed tomography

2015 ◽  
Vol 16 (1) ◽  
pp. 14-20 ◽  
Author(s):  
Christina Sayama ◽  
Caroline Hadley ◽  
Gina N. Monaco ◽  
Anish Sen ◽  
Alison Brayton ◽  
...  
Keyword(s):  
Ct Scan ◽  
Bone Morphogenetic Protein ◽  
Pediatric Population ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Solid Fusion ◽  
Recombinant Human Bone

OBJECT The purpose of this study focusing on fusion rate was to determine the efficacy of recombinant human bone morphogenetic protein–2 (rhBMP-2) use in posterior instrumented fusions of the craniocervical junction in the pediatric population. The authors previously reported the short-term (mean follow-up 11 months) safety and efficacy of rhBMP-2 use in the pediatric age group. The present study reports on their long-term results (minimum of 12 months' follow-up) and focuses on efficacy. METHODS The authors performed a retrospective review of 83 consecutive pediatric patients who had undergone posterior occipitocervical or atlantoaxial spine fusion at Texas Children's Hospital or Riley Children's Hospital during the period from October 2007 to October 2012. Forty-nine patients were excluded from further analysis because of death, loss to follow-up, or lack of CT evaluation of fusion at 12 or more months after surgery. Fusion was determined by postoperative CT scan at a minimum of 12 months after surgery. The fusion was graded and classified by a board-certified fellowship-trained pediatric neuroradiologist. Other factors, such as patient age, diagnosis, number of vertebral levels fused, use of allograft or autograft, dosage of bone morphogenetic protein (BMP), and use of postoperative orthosis, were recorded. RESULTS Thirty-four patients had a CT scan at least 12 months after surgery. The average age of the patients at surgery was 8 years, 1 month (range 10 months–17 years). The mean follow-up was 27.7 months (range 12–81 months). There were 37 fusion procedures in 34 patients. Solid fusion (CT Grade 4 or 4−) was achieved in 89.2% of attempts (33 of 37), while incomplete fusion or failure of fusion was seen in 10.8%. Based on logistic regression analysis, there was no significant association between solid fusion and age, sex, BMP dose, type of graft material, use of postoperative orthosis, or number of levels fused. Three of 34 patients (8.8%) required revision surgery. CONCLUSIONS Despite the large number of adult studies reporting positive effects of BMP on bone fusion, our long-term outcomes using rhBMP-2 in the pediatric population suggest that rates of fusion failure are higher than observed in contemporary adult and pediatric reports of occipitocervical and atlantoaxial spine fusions.

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.

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