Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein—2

2005 ◽  
Vol 3 (6) ◽  
pp. 436-443 ◽  
Author(s):  
Alan T. Villavicencio ◽  
Sigita Burneikiene ◽  
E. Lee Nelson ◽  
Ketan R. Bulsara ◽  
Mark Favors ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Minimally Invasive ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Bone Morphogenetic Protein 2 ◽  
Content Type ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone ◽  
Fine Print

Object. Recombinant human bone morphogenetic protein—2 (rhBMP-2) is being increasingly used for spinal fusion. There are few data regarding its clinical safety, effectiveness, and clinical outcome when applied on an absorbable collagen sponge (ACS) in conjunction with allograft for transforaminal lumbar interbody fusion (TLIF). Methods. Seventy-four consecutive patients undergoing TLIF for degenerative disc disease were divided into five groups depending on whether the patient underwent a minimally invasive or open approach, as well as the number of spinal levels surgically treated. Surgery-related data, fusion results, complications, and clinical outcome were evaluated. The mean follow-up duration was 20.6 months (range 14–28 months). The radiographic fusion rate was 100% at 12 and 24 months after the surgery. No bone overgrowth or other complications related to BMP use were demonstrated. Conclusions. Analysis of the results demonstrated that TLIF combined with a BMP-2—soaked ACS is a feasible, effective, and safe method to promote lumbar fusion. There were no significant intergroup differences in clinical outcome between patients who underwent open compared with minimally invasive procedures. Patient satisfaction rates, however, were higher in the minimally invasive procedure group. The efficacy of BMP-2 was not dependent on which approach was used or the number of spinal levels that were treated.

Use of porous hydroxyapatite graft containing recombinant human bone morphogenetic protein-2 for cervical fusion in a caprine model

1999 ◽  
Vol 90 (2) ◽  
pp. 224-230 ◽  
Author(s):  
Toshiyuki Takahashi ◽  
Teiji Tominaga ◽  
Noriaki Watabe ◽  
A. Toshimitu Yokobori ◽  
Hiroshi Sasada ◽  
...  
Keyword(s):  
Interbody Fusion ◽  
Fusion Rate ◽  
Bone Morphogenetic Protein 2 ◽  
High Dose ◽  
Porous Hydroxyapatite ◽  
Content Type ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone ◽  
Fine Print

Object. The efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) for enhancing anterior cervical spine interbody fusion when added to a porous hydroxyapatite (HA) graft was investigated. Methods. Fourteen mature goats underwent three-level anterior discectomies after induction of endotracheal anesthesia. Porous HA grafts that contained 0, 5, and 50 µg of rhBMP-2 were placed concurrently with anterior cervical spine plates to achieve interbody fusion. The fusion rate, radiological findings, biomechanical stiffness, and histological appearance were evaluated in 42 spinal units immediately and again at 4 and 12 weeks after graft and plate placement. At 12 weeks postsurgery, manual testing showed a 100% fusion rate in the spines with HA grafts containing high-dose rhBMP-2; however, only a 50% fusion rate was shown in spines with grafts that contained no or low-dose rhBMP-2. On radiographic and histological studies the process of solid fusion was seen to be more advanced in relation to the use of larger amounts of rhBMP-2. Biomechanical testing demonstrated significantly higher stiffness values for grafts that contained high-dose rhBMP-2 than those without rhBMP-2 in flexion at 4 weeks, as well as in flexion, extension, and lateral bending tests at 12 weeks. Histological analysis demonstrated that rhBMP-2 increased the amount of bone apposition on the surface of the implants and promoted bone formation in the porous structure without increasing the penetration distance. Conclusions. Through osteogenesis at the fusion site, the addition of rhBMP-2 to a porous HA ceramic graft enhances the rate of anterior cervical fusion.

The safety and utility of recombinant human bone morphogenetic protein-2 for cranial procedures in a nonhuman primate model

2003 ◽  
Vol 98 (1) ◽  
pp. 125-130 ◽  
Author(s):  
Jason P. Sheehan ◽  
Jonas M. Sheehan ◽  
Howard Seeherman ◽  
Mark Quigg ◽  
Gregory A. Helm
Keyword(s):  
Mr Imaging ◽  
Bone Morphogenetic Protein ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Primate Model ◽  
Content Type ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone ◽  
Fine Print

Object. The goal of this study was to evaluate the safety and efficacy of recombinant human bone morphogenetic protein 2 (rhBMP-2) in cranial applications. Methods. Critical-sized calvarial defects were created bilaterally in four rhesus monkeys, and bilateral rectangular bone flaps were created in six others. Control and rhBMP-2—treated sides were randomly chosen for each animal, and an absorbable collagen sponge was used to deliver the growth factor. Over a 6-month period postoperatively, the animals were serially evaluated for bone healing and adverse BMP-related consequences by using the following methods: computerized tomography (CT) scanning, magnetic resonance (MR) imaging, electroencephalography, histological investigations, and cerebrospinal fluid (CSF) analysis. The critical-sized defects for the rhBMP-2—treated and control sides attained 71 ± 12% and 28 ± 11% closure, respectively (four animals; p = 0.04). The CT scans demonstrated that the bone flaps treated with rhBMP-2 had complete osteointegration in five of six animals, whereas scans of the untreated bone flaps demonstrated uniformly poor osteointegration with the intact skull. Histological analysis confirmed well-formed bridges of bone on the rhBMP-2—treated sides. No epileptogenic activity was detected in any of the animals, and MR imaging revealed no evidence of adverse effects on the brain parenchyma. Meningitic irritation was not found on postoperative CSF sample analysis. Conclusions. Treatment of bone flaps and critical-sized cranial defects with rhBMP-2 leads to improved bone formation and osteointegration in nonhuman primates. Initial evaluation of rhBMP-2 appears to indicate a good safety profile for use in cranial procedures in primates.

scholarly journals Evaluation of Heterotopic Ossification After Using Recombinant Human Bone Morphogenetic Protein–2 in Transforaminal Lumbar Interbody Fusion: A Computed Tomography Review of 996 Disc Levels

2019 ◽  
Vol 10 (3) ◽  
pp. 280-285
Author(s):  
Shuo Niu ◽  
Albert T. Anastasio ◽  
Razan R. Faraj ◽  
John M. Rhee
Keyword(s):  
Computed Tomography ◽  
Heterotopic Ossification ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Bone Morphogenetic Protein 2 ◽  
Control Group ◽  
Lumbar Interbody Fusion ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Study Design: Retrospective cohort study. Objectives: Reported incidences and complications of heterotopic ossification (HO) after using recombinant human bone morphogenetic protein–2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF) have been inconclusive. This study was designed to evaluate both incidences of radiologic and symptomatic HO in a large series of TLIFs using rhBMP-2. Methods: A total of 996 disc levels in 927 consecutive TLIF patients were retrospectively evaluated at 6-month postoperative follow-up in a single surgical practice. Subjects were separated into the BMP group and the control group. Operative reports, pre- and postoperative medical records were reviewed. Computed tomography (CT) scans were analyzed and graded independently for ossification at each disc level of TLIF. Results: A total of 933 disc levels were in the BMP group, and 63 were in the control group. Six-month fusion rate of interbody was 92.5% in the BMP group, which was significantly higher in contrast to 71.4% in the control group ( P < .001). The incidence of radiologic HO in the BMP group was 13.5%, which was significantly higher than 1.6% in the control group ( P = .006). After controlling for basic demographics and comorbidities, the presence of radiologic HO was significantly associated with the use of rhBMP-2 ( P = .026). However, only one case in the BMP group (0.11%) developed a symptomatic HO (mild-medium left buttock pain, treated nonsurgically) involving left foramen of L5-S1. Conclusions: rhBMP-2 can be safely used in TLIF with regard to HO. There was a low rate of radiologic HO and minimal symptomatic HO, with high fusion rates at 6 months postoperative.

Evaluation of 70/30 poly (l-lactide-co-d,l-lactide) for use as a resorbable interbody fusion cage

2002 ◽  
Vol 97 (4) ◽  
pp. 423-432 ◽  
Author(s):  
Jeffrey M. Toth ◽  
Bradley T. Estes ◽  
Mei Wang ◽  
Howard B. Seim ◽  
Jeffrey L. Scifert ◽  
...  
Keyword(s):  
Interbody Fusion ◽  
Bone Morphogenetic Protein 2 ◽  
Content Type ◽  
Chronic Inflammatory Response ◽  
Statistical Measures ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Fusion Cage ◽  
Fine Print

Object. Titanium lumbar interbody spinal fusion devices are reported to be 90% effective in cases requiring single-level lumbar interbody arthrodesis, although radiographic determination of fusion has been debated. Methods. Using blinded radiographic, biomechanical, histological, and statistical measures, researchers in the present study evaluated a radiolucent 70/30 poly(l-lactide-co-d,l-lactide) interbody fusion device packed with autograft or recombinant human bone morphogenetic protein—2 on a collagen sponge in 25 sheep at 3, 6, 12, 18, and 24 months. A trend of increased fusion stiffness, radiographic fusion, and histologically confirmed fusion was demonstrated at 3 months to 24 months postimplantation. Device degradation was associated with a mild to moderate chronic inflammatory response at all postoperative sacrifice times. Conclusions. Use of this material in interbody fusion may be a viable alternative to metals.

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