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.

Routine Use of Recombinant Human Bone Morphogenetic Protein-2 in Posterior Fusions of the Pediatric Spine: Safety Profile and Efficacy in the Early Postoperative Period

Neurosurgery ◽  
2010 ◽  
Vol 67 (5) ◽  
pp. 1195-1204 ◽  
Author(s):  
Daniel K Fahim ◽  
William E Whitehead ◽  
Daniel J Curry ◽  
Robert C Dauser ◽  
Thomas G Luerssen ◽  
...  
Keyword(s):  
Bone Morphogenetic Protein ◽  
Pediatric Population ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Lumbosacral Spine ◽  
Wound Infections ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Abstract BACKGROUND: Previous studies using recombinant human bone morphogenetic protein-2 (rhBMP-2) in the adult lumbar spine have shown consistently good results. There have been no pediatric case series. OBJECTIVE: To determine the safety and efficacy of rhBMP-2 use in posterior instrumented fusions of the pediatric population. METHODS: A retrospective review of 19 consecutive pediatric patients who underwent posterior occiptocervical, cervical, thoracic, lumbar, or lumbosacral spine fusion from October 1, 2007, to June 30, 2008, at Texas Children's Hospital was performed. The average age was approximately 12 years old (range, 9 months to 20 years). The minimum follow-up was 17 months (average of 19 months, range: 17–25 months), with computed tomography (CT) evaluation and grading of fusion by an independent radiologist at 3 months after surgery. RESULTS: The average CT grade was 3, indicating bilateral bridging bone. No pseudoarthroses or loss of correction was identified clinically or radiographically at 3 months and latest follow-up. There was one complication of bony overgrowth and restenosis of the spinal canal necessitating reoperation, and two superficial wound infections. There were no deep wound infections. CONCLUSION: Early outcomes using rhBMP-2 in the pediatric population show that it is a safe and efficacious adjunct to posterior spine fusions of the occipitocervical, cervical, thoracic, lumbar, and lumbosacral spine. It dependably results in the development of stable bridging bone at 3 months after surgery with good maintenance of correction and stability in long-term follow-up. Lessons learned from the case of unexpected bony overgrowth are discussed.

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.

Acute renal insufficiency, supraventricular tachycardia, and confusion after recombinant human bone morphogenetic protein-2 implantation for lumbosacral spine fusion

2008 ◽  
Vol 8 (6) ◽  
pp. 589-593 ◽  
Author(s):  
Yaron A. Moshel ◽  
Edgar I. Hernandez ◽  
Li Kong ◽  
Chuanju Liu ◽  
Uzma Samadani
Keyword(s):  
Renal Insufficiency ◽  
Bone Morphogenetic Protein ◽  
Supraventricular Tachycardia ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Lumbosacral Spine ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Acute Renal Insufficiency ◽  
Recombinant Human Bone

✓The authors report on a case of a patient who received recombinant human bone morphogenetic protein-2 (rhBMP-2) to augment spinal fusion for the first and third of 3 lumbosacral fusion surgeries. After receiving rhBMP-2 the first time, the patient became febrile and developed mild acute renal insufficiency and transient supraventricular tachycardia (SVT). The second operation was complicated only by perioperative fever. When the patient received rhBMP-2 again during the third operation, he developed fever, acute oliguric renal insufficiency, symptomatic SVT with hypoxemia, confusion, and joint pain. No clear cause of these problems was identified; however serum analysis revealed the presence of an antibody to rhBMP-2. The authors discuss potential mechanisms for the patient's putative reaction to rhBMP-2, as the findings from a literature review suggest this is the first such reaction to be reported.

Recombinant Human Bone Morphogenetic Protein-2 as an Adjunct for Spine Fusion in a Pediatric Population

2011 ◽  
Vol 47 (4) ◽  
pp. 266-271 ◽  
Author(s):  
Muhammad M. Abd-El-Barr ◽  
J. Bridger Cox ◽  
Michael U. Antonucci ◽  
Jeffrey Bennett ◽  
Gregory J.A. Murad ◽  
...  
Keyword(s):  
Bone Morphogenetic Protein ◽  
Pediatric Population ◽  
Spine Fusion ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
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.

Safety, Efficacy, and Dosing of Recombinant Human Bone Morphogenetic Protein-2 for Posterior Cervical and Cervicothoracic Instrumented Fusion With a Minimum 2-Year Follow-up

Neurosurgery ◽  
2011 ◽  
Vol 69 (1) ◽  
pp. 103-111 ◽  
Author(s):  
D Kojo Hamilton ◽  
Justin S Smith ◽  
Davis L Reames ◽  
Brian J Williams ◽  
Daniel R Chernavvsky ◽  
...  
Keyword(s):  
Bone Morphogenetic Protein ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Atlantoaxial Instability ◽  
Cervical Fusion ◽  
Instrumented Fusion ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Abstract BACKGROUND: Considerable attention has focused on concerns of increased complications with recombinant human bone morphogenetic protein-2 (rhBMP-2) use for anterior cervical fusion, but few reports have assessed its use for posterior cervical fusions. OBJECTIVE: To assess the safety, efficacy, and dosing of rhBMP-2 as an adjunct for instrumented posterior cervical arthrodesis. METHODS: All patients treated by the senior author with posterior cervical or cervicothoracic instrumented fusion using rhBMP-2 from 2003 to 2008 with a minimum of 2 years of follow-up were included. Diagnosis, levels fused, rhBMP-2 dose, complications, and fusion were assessed. RESULTS: Fifty-three patients with a mean age of 55.7 years (range, 2-89 years) and an average follow-up of 40 months (range, 25-80 months) met inclusion criteria. Surgical indications included basilar invagination (n = 6), fracture (n = 6), atlantoaxial instability (n = 16), kyphosis/kyphoscoliosis (n = 22), osteomyelitis (n = 1), spondylolisthesis (n = 1), and cyst (n = 1). Fifteen patients had confirmed rheumatoid disease. The average rhBMP-2 dose was 1.8 mg per level, with a total of 282 levels treated (average, 5.3 levels; SD, 2.8 levels). Among 53 patients, only 2 complications (3.8%) were identified: a superficial wound infection and an adjacent-level degeneration. No cases of dysphagia or neck swelling requiring treatment were identified. At the last follow-up, all patients had achieved fusion. CONCLUSION: Despite many of the patients in the present series having complex pathology and/or rheumatoid arthritis, a 100% fusion rate was achieved. Collectively, these data suggest that use of rhBMP-2 as an adjunct for posterior cervical fusion is safe and effective at an average dose of 1.8 mg per level.

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