A level III study by Kim et al.154 further concluded that rhBMP-2 is in fact superior to ICBG in achieving fusion in long constructs for adult spinal deformity. Vaccaro AR, Whang PG, Patel T, et al. Joel Finkelstein. Epstein NE. a two-year follow-up. Mobbs RJ, Maharaj M, Rao PJ. Based on application, the market is classified into long bone, spinal fusion, foot and ankle, joint reconstruction, craniomaxillofacial, and dental. Other level III and level IV data similarly related favorable fusion outcomes with allograft use in the cervical spine. Does it work? Bone Grafts And Substitutes Market Size, Share & Trends Analysis Report by Material Type (Allograft, Synthetic), by Application (Spinal Fusion, Foot & Ankle, Joint Reconstruction), by Region, and Segment Forecasts, 2022-2030 Read Paper. Utilization of DBM for spine fusion has typically been in combination with some form of structural bone substitute or interbody cage, with no clinical evidence supporting the use of DBM as a standalone substitute. Bookshelf Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2. An HS, Lynch K, Toth J. Boden SD, Kang J, Sandhu H, Heller JG. Centrella M, McCarthy TL, Canalis E. Platelet-derived growth factor enhances deoxyribonucleic acid and collagen synthesis in osteoblastenriched cultures from fetal rat parietal bone. The rest of the data on rhBMP-2 use in posterior cervical fusions is limited at present to four level IV studies,148151 all of which reported good to excellent fusion rates (82.8% to 100%) and patient outcomes, mostly pertaining to its application to occipito-cervical fusion. Slosar PJ, Josey R, Reynolds J. Challenges of bone tissue engineering in orthopaedic patients. Hybrid grafting using bone marrow aspirate combined with porous -tricalcium phosphate and trephine bone for lumbar posterolateral spinal fusion: a prospective, comparative study versus local bone grafting. However, they may occasionally cause inflammation. There is little evidence on the efficacy of demineralised bone matrix for spinal fusion. Spinal fusion is a very common back and neck surgery. Cancellous bone graft has greater cellular activity than cortical graft, whereas cortical graft is stronger. 1Pennsylvania Hospital of the University of Pennsylvania Health System, Philadelphia, PA, 3Toronto Western Hospital, Toronto, Canada, 4Center for Spine & Orthopaedics, Denver, CO. In a level I prospective multicenter randomized clinical trial, Kang et al.48 reported on the efficacy of a DBM preparation (Grafton DBM) compared with iliac crest autograft for single-level posterior lumbar fusion. In fact, after a retrospective cohort study Adams et al.124 concluded that rhBMP-2 may unnecessarily increase the risk of complications in routine PLIF and TLIF procedures. An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. Reports evaluating the use of DBM in lumbar spine fusions are numerous. Prospective comparison of autograft vs. allograft for adult posterolateral lumbar spine fusion: differences among freeze-dried, frozen, and mixed grafts. Invited submission from the Joint Section Meeting on Disorders of the Spine. The patients were matched to a control group of 57 patients, where only interbody allograft spacer was used. However, the upside is that this bone is much better as it contains your own cells that immediately go to work to start the fusion process. Comparable results were reported by Chang et al.97 in a level III retrospective study of 66 patients who underwent single level posterolateral lumbar fusions with Osteoset. Although bone morphogenetic proteins . For this reason there exists a significant amount of interest in bone graft substitutes and enhancers to improve clinical outcomes for these patients. Delawi D, Jacobs W, van Susante JLC, et al. Qian JJ, Bhatnagar RS. Topuz K, Colak A, Kaya S, et al. Both prospective and retrospective studies were included. Two level 152153, two level III154, 155 and one level IV156 studies investigating the efficacy of rhBMP-2 for adult spinal deformity correction were found. Wright JG, Swiontkowski MF, Heckman JD. -Multiple level spinal fusion Enhancer -To improve success of autogenous bone graft Substitute -To replace autogenous bone graft. Allograft cellular bone matrix in extreme lateral interbody fusion: preliminary radiographic and clinical outcomes. The safety and efficacy of rhBMP-2 in this clinical context is supported by three level IV studies.160162. Glassman SD, Carreon L, Djurasovic M, et al. Please enable it to take advantage of the complete set of features! Autologous growth factors, Stem cell based substitutes and Synthetic peptides are relatively novel, and data thereof was less forthcoming. Thalgott JS, Fogarty ME, Giuffre JM, Christenson SD, Epstein AK, Aprill C. A prospective, randomized, blinded, single-site study to evaluate the clinical and radiographic differences between frozen and freeze-dried allograft when used as part of a circumferential anterior lumbar interbody fusion procedure. Delawi et al.163 in a prospective randomized study (level 1) evaluated OP-1 for single level instrumented posterolateral fusion surgery for degenerative or isthmic spondylolisthesis. The authors recommended avoiding the use of -TCP due to high pseudoarthrosis rates. What bone graft substitutes should we use in post-traumatic spinal fusion? The use of platelet gel in posterolateral fusion: preliminary results in a series of 14 cases. A bone graft is defined as using bone-in spine fusion surgery. Radiological fusion was achieved at 1 year postoperatively in all groups and vertebral segments. Acid extraction of the bone results in a product that consists of a combination of organic matrix proteins (osteoconductive) with small quantities of growth differentiation factors (osteoinductive). Fusion was assessed using plain-films and CT scans for bone formation in the arthrodesed interbody spaces. Allograft is bone derived from cadavers. Bone Morphogenetic Proteins (BMP) are another type of bone graft option, as detailed on the following page. Fourteen studies417 evaluating the use of allografts in surgery for degenerative cervical spine were identified (one level I4, two level II8, 13, seven level III6, 7, 9, 10, 1517 and four level IV5, 11, 12, 14). Luhmann SJ, Bridwell KH, Cheng I, Imamura T, Lenke LG, Schootman M. Use of bone morphogenetic protein-2 for adult spinal deformity. There is a large and established opportunity for NB1 with an estimated global market of $3 billion annually just for bone graft substitutes in spine fusion for products such as growth factors, DBM, synthetic materials, stem cells and allografts. The recovery time takes 3 to 12 months, and during this time, the patient should avoid some things. Moreover, current procedural technology (CPT) code 20939 became effective in 2018 defining bone marrow aspirate for bone grafting, spine surgery only. Bone graft substitutes are widely used in the field of orthopedics and are extensively used to promote vertebral fusion. These were further grouped depending on their application in lumbar and cervical spine surgeries, deformity correction or other miscellaneous procedures viz. Plain radiographs (standing AP and lateral views, supine oblique right and left, and sitting frontal and lateral bending views) were obtained preoperatively and at 3, 6, 12, 24 and 48 months postoperatively. Epub 2011 Aug 15. Bone Grafts in Spine Surgery. Int J Nanomedicine. Demineralized bone matrix (DBM) is derived from human allograft bone. The site is secure. Kim HJ, Buchowski JM, Zebala LP, Dickson DD, Koester L, Bridwell KH. 119 patients undergoing surgery were randomized 1:1 for bone-grafting (59: ICBG group and 60: OP-1 group). Bone graft and/or bone graft substitute is needed to create the environment for the solid bridge to form. Calcium phosphate compounds appear to be good as carriers; however, they have no osteoinductive or osteogenic properties. Nineteen patients had supplemental bone grafting with DBM putty enriched with aspirated bone marrow, 27 patients had DBM putty combined with iliac crest autograft, and the control group consisted of 27 patients with autograft. The primary outcome measures were available and evaluated for 113 (56: ICBG group and 57: OP-1 group) of the 119 patients at one year, consisting of a combination of clinical outcomes and evidence of fusion as determined on CT scans. Spine Deform. It is difficult to draw conclusions for use in the lumbar spine, although very recent level III and IV data suggest ABM/P-15 may be beneficial for lumbar fusion. While the benefits of autograft are numerous and hard for bone graft substitutes to replicate, there are some drawbacks. Despite the remarkable advancements in the field of bone graft alternatives for spinal fusion, no graft substitute/expander to date has demonstrated clear superiority over autologous iliac crest graft. in two level II studies121, 122 in the context of rhBMP-2 use for anterior lumbar interbody fusions. Bone Graft Substitutes for Cervical Spinal Fusion Surgery. Bone Graft Alternatives. The new PMC design is here! Andrs-Cano P, Cervn A, Rodrguez-Solera M, Antonio Ortega J, Rebollo N, Guerado E. Orthop Surg. Another example of therapeutic proteins are bone morphogenetic proteins (BMPs) used in spinal fusions. They allow for bone growth on their surface and then they are resorbed by the body, with the patients own bone remaining in place. The type and position of spinal bone grafts affect spinal fusion. A number of level IV studies4447 reported acceptable to good fusion rates (ranging from 88.9% to 97%) and comparable clinical outcomes using a combination of DBM and interbody cages for cervical fusion. A total of 33 studies (seven level I109115, eight level II116123, eight level III124131, nine level IV132140, one unclassified141) were identified pertaining to rhBMP-2 use in the lumbar spine alone. The procedure of anterior lumbar interbody fusion (ALIF) is commonly performed on patients suffering from . Clinical outcomes using the Oswestry low back pain Disability Index (ODI) also demonstrated no significant differences in allograft and autograft groups. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Geibel PT, Boyd DL, Slabisak V. The use of recombinant human bone morphogenic protein in posterior interbody fusions of the lumbar spine: a clinical series. Demineralized bone matrix is associated with variable outcomes and is dependent upon the formulation used and differences in factors such as product batch. As such, DBM can be mixed with regular bone to obtain more graft volume when it is needed for fusion. Guth K, Buckland T, Hing KA. sharing sensitive information, make sure youre on a federal The authors previous conclusions that OP-1 combined with locally obtained autograft was a safe and effective alternative for iliac crest autograft was overturned in the newer study and it was asserted that OP-1 cannot be recommended in instrumented posterolateral lumbar fusion procedures. This site needs JavaScript to work properly. Bone graft substitutes are man-made version of a natural product, whether chemicals or devices to stimulate bone growth and fusion. Clinical outcomes in all groups improved significantly overall; however the increment in outcome measures was not statistically superior for the rhBMP-2 groups in either study. Graham et al.4 in a prospective randomized control trial (level I) comparing glycerol preserved versus freeze dried allografts for anterior cervical fusion reported fusion rates greater than 95% in both groups, which were not statistically different (p = 0.2127 and 0.1705 for the 3- and 6-month follow-up, respectively). This graft material is necessary to trick the body into causing living bone to cross the gap and join to the other side. A variety of DBM preparations have been made commercially available in the form of powders, granules, gels, putties, and strips. FOIA 1 - 3 however, the burden of donor-site morbidity from icbg harvesting is both a significant and common occurrence, which has significantly limited its use clinically. Prospective analysis of a new bone graft in lumbar interbody fusion: results of a 2- year prospective clinical and radiological study. Bethesda, MD 20894, Web Policies The graft material used in spinal fusion procedures can be generally categorized into three main types of materials: autogenous bone graft (autograft) from the patient's own body, allograft from human cadavers and/or living donors, and synthetic bone graft or substitutes (Table 1). Yoshii T, Yuasa M, Sotome S, et al. The authors concluded that ABM/P-15 has equal or greater efficacy at 6 and 12 months compared to autograft.191 Mobbs et al.196 (level IV) reported on a prospective analysis performed in Australia of a nonblinded cohort of patients who received i-Factor for an ALIF. The role of Osteocel Plus as a fusion substrate in minimally invasive instrumented transforaminal lumbar interbody fusion. Nandyala SV, Marquez-Lara A, Singh K. A Prospective, Randomized, Controlled Trial of Silicate Substituted Calcium Phosphate Versus rhBMP-2 in a Minimally Invasive Transforaminal Lumbar Interbody Fusion. They are highly osteoconductive, variably osteoinductive and lack osteogenic properties due to the loss of cellular elements during processing to reduce immunogenicity. Would you like email updates of new search results? Bone Graft Substitutes The formation of new bone requires three key processes: osteogenesis (synthesis of new bone), osteoinduction (recruitment of stem cells and their differentiation into bone cells), and osteoconduction (the development of adequate blood supply to the new bone and correct structuring of the new bone cells). Page 2 of 6 Criteria Commercial Prior authorization is required. While allograft has the benefit of not requiring the additional surgical site associated with autograft, the downsides include a small risk of disease transmission and reduced bone strength due to the elimination of bone growth cells and proteins when the bone is disinfected. Autologous growth factors and platelet gels have failed to demonstrate any advantage in terms of fusion efficacy. At first, bone morphogenetic protein referred to as rhBMP-2 was just used for single level spinal fusions. Introducing levels of evidence to the journal. Other level I studies by Glassman et al.112 and Boden et al.115 comparing rhBMP-2 to AICBG for posterolateral lumbar fusions reported higher fusion grades, with fusion rates approaching 100% in the study groups. I-Factor (Cerapedics, Inc., Westminster, CO) is a proprietary composite consisting of P-15 adsorbed to anorganic bovine bone mineral (ABM). Mesenchymal stem cell allograft as a fusion adjunct in one- and two-level anterior cervical discectomy and fusion: a matched cohort analysis. Yan L147 recently reported on a prospective, randomized trial (Level II) for the use of ICBG plus rhBMP-2/ACS (Infuse) vs. ICBG alone in 140 patients who underwent instrumented posterior fusion for the treatment of atlantoaxial instability. A level III study by Wimmer et al.28 involved 94 patients with spondylolisthesis treated with anterior interbody fusion using either iliac crest autograft or femoral head allograft supplemented by pedicle screws posteriorly. Comparison of allograft to autograft in multilevel anterior cervical discectomy and fusion with rigid plate fixation. eCollection 2016. Orthopedics. Compared to rhBMP-2, the use of rhBMP-7 for other lumbar spine procedures (e.g. Copyright 2011 Elsevier Ltd. All rights reserved. Nagineni V V, James AR, Alimi M, et al. The basic idea is to fuse together painfulor unstable bones in the spine so that they heal into a single, solid bone. 2015; 6(6): 449456. government site. Hamilton DK, Jones-Quaidoo SM, Sansur C, Shaffrey CI, Oskouian R, Jane JA. Veritas Health, LLC, Bendo JA, Spivak JM, Neuwirth MG, Chung P. Use of the anterior interbody fresh-frozen femoral head allograft in circumferential lumbar fusions. Singh K, Smucker JD, Gill S, Boden SD. Fusion rates after thoracoscopic release and bone graft substitutes in idiopathic scoliosis. The global spine market is $10 billion and growing in low single digits. Vanichkachorn J, Peppers T, Bullard D, Stanley SK, Linovitz RJ, Ryaby JT. Spinal fusion bone graft substitutes are used in minimally invasive procedures and therefore, the rising demand for minimally invasive surgeries is expected to boost market growth over the forecast period. Demineralized bone matrix (DBM)Demineralized bone matrix (DBM) is allograft bone that has had its mineral content (calcium) removed. Use of allograft bone for posterior C1-2 fusion. 5,7 Bony fusion in PSF is usually achieved by dorsolateral decortication and application of autologous iliac crest bone graft (ICBG), 8,9 a technique for which the reported rate of pseudarthrosis is less . On the contrary, a posterior applied bone graft is placed along the tension side of the spinal column. Current Updates on Bone Grafting Biomaterials and Recombinant Human Growth Factors Implanted Biotherapy for Spinal Fusion: A Review of Human Clinical Studies. One report (level 1) was available describing a single-blind randomized non-inferiority control trial.192 This study compared i-Factor (N=165) to iliac crest autograft (N=154) for use in single-level ACDF procedures for cervical radiculopathy. Dawson et al.116 performed a prospective, randomized, multicenter pilot study investigating the use of rhBMP-2 on an absorbable collagen sponge (12 mg rhBMP-2 dose) combined with a ceramic-granule bulking agent as a replacement for autogenous ICBG in single level instrumented posterolateral lumbar arthrodesis. Nevertheless, with such a plethora of available options, and with such diversity in the data on their application under different scenarios and in different combinations, it becomes necessary for spine surgeons to scrutinize all options carefully before adopting them in clinical practice. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. The authors wish to thank Robin Hashimoto, PhD, and Joseph R. Dettori, PhD, MPH for their assistance in the preparation of this manuscript. Stevenson S, Emery SE, Goldberg VM. Stabilize a spinal deformity. Preliminary documentation of the comparable efficacy of vitoss versus NanOss bioactive as bone graft expanders for posterior cervical fusion. Fibular allograft after anterior cervical corpectomy: long term follow-up. In this way, they can heal together. Data on the application of HA to scoliosis surgery is also limited to a single case series. Yan L, Chang Z, He B, et al. Anterior lumbar interbody fusion with processed sea coral (coralline hydroxyapatite) as part of a circumferential fusion. Hodges SD, Eck JC, Newton D. Retrospective study of posterior cervical fusions with rhBMP-2. The spine journal : official journal of the North American Spine Society. ChronOS beta tri-calcium phosphate bone graft substitute for indications other than spinal fusion Collagen-based bio-inductive implants (e.g., Regeneten) for repair of rotator cuff tears Cook anal fistula plug DeNovo NT natural tissue (allogeneic minced cartilage) graft EmCell (fetal stem cell therapy) Instead, the bone graft provides the foundation and environment to allow the body to grow new bone and fuse a section of the spine together (into one long bone). Data on -TCP use for lumbar spine fusions is inconclusive in view of conflicting results reported across all evidence levels of studies. Ceramic granules enhanced with B2A peptide for lumbar interbody spine fusion: an experimental study using an instrumented model in sheep. Singh K, DeWald CJ, Hammerberg KW, De-Wald RL. Overview of 317 cases and literature review. The differences in porosities and compositions of commercially available hydroxyapatite products make generalization across the group difficult. Gerszten PC, Tobler WD, Nasca RJ. Enhanced cell attachment to anorganic bone mineral in the presence of a synthetic peptide related to collagen. Given the known risks and morbidity of harvesting iliac crest bone graft, the historical gold standard for spinal fusion, these biologic materials serve the purpose of improving both the efficacy and safety of spinal fusion procedures. Ceramics are also utilized as bone graft extenders and results are generally supportive, although limited. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions. No level I studies could be identified in this subgroup. The authors concluded that i-Factor met all FDA non-inferiority criteria and demonstrated safety and efficacy in this patient group.192, Two articles were found describing use of i-Factor for lumbar fusion procedures. Complications in Spinal Fusion Surgery: A Systematic Review of Clinically Used Cages. "As the aging population increases and we are starting to do more surgeries that require spinal fusions, we are augmenting our fusion with BMP, synthetics and allografts instead of autograft," says Dr. Bae. Ever since the introduction of allograft as a substitute for autologous bone in spinal surgery, a sea of literature has surfaced, evaluating both established and newly emerging fusion alternatives. A comparison of autogeneic and allogeneic bone grafts. In contrast, Alexander et al.95 found that calcium sulfate pellets plus local decompression bone provided equivalent results compared to autologous ICBG in his preliminary paper on a prospective randomized study sample. Bone grafts and bone substitutes are indispensable for achieving and maintaining fusion and intersegmental stability in spine surgery. Epub 2007 May 25. Wenisch S, Stahl J-P, Horas U, et al. The authors concluded that the combination of an osteoinductive agent with an osteoconductive matrix may be an effective replacement for autograft in instrumented single-level PLIF. A prospective study of Autologous Growth Factors (AGF) in lumbar interbody fusion. Khajavi K, Shen A. Would you like email updates of new search results? Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Epub 2021 Apr 29. "BMP is a potent molecule and its commercial growth has slowed due to its side effects. This product is available commercially as putty consisting of recombinant OP-1 (rhOP-1) with type I bovine collagen matrix and sodium carboxymethyl cellulose (CMC) as an additive, to be reconstituted with 0.9% sterile saline solution. Fusion rates assessed with both radiographs and CT scans was higher for the hybrid bone graft side (68.9% at 6 months, 83.6% at 1 year, 93.5% at 2 years) than that for the local bone graft side (49.2% at 6 months, 75.4% at 1 year, 89.1% at 2 years) with a significant difference at 6 months after surgery (p < 0.05). However the brittle nature and low shear strength of ceramic grafts limit their use as a standalone bone substitute. All of these studies reported good fusion rates (ranging from 90.2 % to 92.3%) and supported the safety profile of this novel bone extender. 2018 May;10(2):89-97. doi: 10.1111/os.12371. With many successful bone graft options available today, your surgeon will select the right type(s) for you to give your spinal fusion the best chance of healing properly. The .gov means its official. By 24 months, 95% of patients in the investigational group compared with 70% in the control group had documented fusion (assessed with radiographs and CT scan) (p = 0.120). Dawson E, Bae HW, Burkus JK, Stambough JL, Glassman SD. Aurori BF, Weierman RJ, Lowell HA, Nadel CI, Parsons JR. Pseudarthrosis after spinal fusion for scoliosis. about navigating our updated article layout. At 1 year postoperatively, the fusion rate difference between groups 1 and 2 remained insignificant (p = 0.3376). Average curve correction was reported at 61.7% in the -TCP group and 61.2% in the ICBG group at hospital discharge (p = 0.313) and 57.2% and 54.3%, respectively, at follow-up (p = 0.109). Lastly, data on stem cell based products and the synthetic peptides is currently very limited, having only recently popped up on the horizon. Spine J. Sarwat AM, OBrien JP, Renton P, Sutcliffe JC. A short summary of this paper. Bookshelf PacificSource Medicare follows MCG Lumbar Fusion S-820 and MCG Cervical Fusion, Anterior S-320 for bone graft substitutes used for spinal fusions. Two cages were placed, one on each lateral side of the interbody space, such that each patient received both the study material and autograft and therefore acted as his or her own control.191 Fusion was assessed by using CT images. Bone graft substitutes are widely used in the field of orthopedics and are extensively used to promote vertebral fusion. 37 Full PDFs related to this paper. Stability so bone can form. In general, these types of bone graft are a synthetic or a manipulated type of a naturally-occurring product. The advantages include no risk of disease transmission and ready availability. Another commercially available ACBM that has been studied and recently quoted is Trinity Evolution (Musculoskeletal Transplant Foundation, Edison, NJ, USA). Jenis LG. Allograft; Autograft; Bone enhancers; Bone graft substitutes; Spine fusion. This site is for educational purposes only; no information is intended or implied to be a substitute for professional medical advice. HHS Vulnerability Disclosure, Help Bishop RC, Moore KA, Hadley MN. A review of clinical articles on the topic of bone graft substitutes/expanders/extenders was conducted. Primary endpoints were radiological fusion rates and successful clinical outcomes. The field of bone grafts in spine surgery has evolved rapidly . Use of an advanced formulation of beta-tricalcium phosphate as a bone extender in interbody lumbar fusion. Accessed November 2, 2018. To prevent disease transmission, allograft bone is thoroughly disinfected. A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion. Long Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities. Vaccaro AR, Patel T, Fischgrund J, et al. Hurlbert RJ, Alexander D, Bailey S, et al. One article (level II) was available reporting initial results from a clinical trial comparing autograft to B2A.194 Twenty-four patients undergoing single-level TLIF were randomized to receive 150 mg/cm3 of B2A, 750 mg/cm3 granules of B2A, or ICBG. Additional favorable properties of ceramics include the biodegradable nature, feasibility of large scale production and ease of sterilization, non-immunogenicity, and relative lack of toxicity. Autograft bone graft is taken from your own body, most likely from your hip (really the pelvis), ribs, or leg. Anteroposterior, lateral and flexion-extension radiographs taken 12 months after surgery were used to analyze fusion. Other studies (level II, III and IV) however are in support of the use of calcium sulphate as a bone graft extender in combination with local autologous bone obtained from decompression. Anterior interbody (between the bone bodies) structural grafts are exposed to local compressive forces. Urrutia J, Molina M. Fresh-frozen femoral head allograft as lumbar interbody graft material allows high fusion rate without subsidence. Epub 2005 Apr 1. Learn more Bone marrow concentrate with allograft equivalent to autograft in lumbar fusions. Buttermann GR. Accessibility official website and that any information you provide is encrypted Accessibility A total of thirteen articles4860 (one level I48, two level II53, 54, five level III49, 50, 56, 59, 60 and five level IV51, 52, 55, 57, 58) were identified in this subclass. Autologous ICBG was placed on one side in the posterolateral gutter in all patients as a control, and on the other side an equal quantity of laminectomy bone chips mixed with BMA (group 1, n = 21) or calcium sulfate pellets soaked in BMA (group 2, n=22) were used. Surgical Infection after Posterolateral Lumbar Spine Arthrodesis: CT Analysis of Spinal Fusion. It has been used in dental applications for over a decade and has recently been adopted for use in the spine. Use of allografts for cervical fusions is supported in published literature for both anterior (level I, II, III, IV data) and posterior cervical fusions (level III, IV data). Adjuncts in posterior lumbar spine fusion: comparison of complications and efficacy. Bovine-derived xenograft is a viable bone graft substitute in multilevel, instrumented, spinal fusion. Radiographically assessed fusion occurred within 61 months in both groups (p < 0.87), with no pseudoarthrosis observed. will also be available for a limited time. Crandall DG, Revella J, Patterson J, Huish E, Chang M, McLemore R. Transforaminal lumbar interbody fusion with rhBMP-2 in spinal deformity, spondylolisthesis, and degenerative disease--part 1: Large series diagnosis related outcomes and complications with 2- to 9-year follow-up. Fusion evaluation was done by CT scans performed using 1-mm slices with coronal and sagittal reconstructions. Burkus JK, Sandhu HS, Gornet MF, Longley MC. 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. Unfortunately, since that is not the rule, conclusions drawn from current literature are very unreliable. During the early years of bone grafting in spine surgery, bone grafts were used on tuberculosis patients, and the structural support of the graft was most the important consideration. Park H-W, Lee J-K, Moon S-J, Seo S-K, Lee J-H, Kim S-H. The surgeon may also take bone from your spine, known as local autograft. A comparison of posterolateral lumbar fusion comparing autograft, autogenous laminectomy bone with bone marrow aspirate, and calcium sulphate with bone marrow aspirate: a prospective randomized study. Veronesi F, Sartori M, Griffoni C, Valacco M, Tedesco G, Davassi PF, Gasbarrini A, Fini M, Barbanti Brodano G. J Clin Med. There are potential risks of using BMP, so the surgeon needs to have experience with this substance. Download Download PDF. RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age. Haid RW, Branch CL, Alexander JT, Burkus JK. The overall percentage agreement for fusion status between sides reported was approximately 75%, suggesting moderately strong statistical correspondence (k = 0.51, p<0.0001). 520 Lake Cook Road, Suite 350, Similarly high fusion rates (94.5 - 100%) were reported by Burkus et al. Autograft remains the gold standard, and cancellous bone is advisable in posterolateral approaches, whereas tricortical iliac crest autograft appears appropriate for interbody support. However four level IV studies (using CHA88, porous HA89, porous/dense HA composite90 and nano-HA/polyamide cages91) reported good results (fusion rates ranging from 92.50% to 100%) and concluded that HA was an effective alternative to autologous iliac crest graft. Their composition is similar to allograft. Table 1 Bone substitutes resuming. Of note, rhBMP-7 (OP-1) has only been studied for posterolateral lumbar fusions. Price CT, Connolly JF, Carantzas AC, Ilyas I. A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease. There are several level I and level II studies describing rhBMP-2 usage in anterior lumbar fusion applications. Lauweryns P, Raskin Y. Dai L-Y, Jiang L-S. Single-level instrumented posterolateral fusion of lumbar spine with beta-tricalcium phosphate versus autograft: a prospective, randomized study with 3-year follow-up. The authors concluded that the use of -TCP as extenders of local bone graft yielded results equivalent to ICBG in the posterior correction of AIS. freeze drying). The authors suggested that some modification of either the surgical technique or the carrier may be required for extensive use of OP-1 in instrumented posterolateral lumbar fusion. At the last follow up, the 92.3% fusion rate in the investigational group was higher than that of the control group at 77.8%, although this result was not statistically significant. Long structural allografts in the treatment of anterior spinal column defects. Injury. The bulk of the literature on demineralized bone matrix pertains to the lumbar spine, wherein DBM has been shown to be an effective bone extender, when used to augment the volume of autograft (across all evidence level studies). Constructs of hybrid bone grafts (-TCP [Osferion] + autologous iliac crest bone strips + autologous bone marrow aspirates) were placed on one side of the inter-transverse gutter in all patients. However the combination of laminectomy bone with CHA (group 3) failed to yield a satisfactory fusion rate (57.9%) up to one year after surgery if no autologous iliac crest graft was added (p = 0.0217). Since demineralized bone matrices lack structural strength, they cannot be used independently in situations where biomechanical stability is required. The purpose of a spinal bone graft is . Recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with an osteoconductive bulking agent in posterolateral arthrodesis with instrumentation. Multiple level III and level IV studies have been published regarding rhBMP-2 use for lumbar interbody fusions performed with the anterior (ALIF)139, transforaminal (TLIF)124126, 131 and posterior (PLIF)124 approaches as well as postero-lateral (PLF)128130 and axial (AxiaLIF)127 techniques. Of the more than 20 types of BMPs described, BMP- 2 and BMP-7 (also known as Osteogenic protein-1, or OP-1), in their recombinant forms (rh), are the most widely used BMPs in clinical practice. The body part is joined together by fixation device, bone graft, or other means. Trauma Researchers are seeing promise in the bone healing properties of bone marrow-derived mesenchymal stem cells, gene therapy, and tissue engineering. At 12, 18, and 24 months, lateral decubitus flexion-extension films also were included to confirm fusion integrity. Contribution of recombinant human bone morphogenetic protein-2 to the rapid creation of interbody fusion when used in transforaminal lumbar interbody fusion: a preliminary report. The role of DBM as a fusion extender in conjunction with autograft was investigated by Cammisa et al.54 (level II) in a 120 patient series undergoing instrumented posterolateral lumbar fusion. Epstein NE. OP-1 Compared with Iliac Crest Autograft in Instrumented Posterolateral Fusion: A Randomized, Multi-center Non-Inferiority Trial. The growth can be attributed to the rising adoption of bone graft materials for spondylosyndesis. Delecrin et al.78 also reported favorable results for the use of porous biphasic calcium phosphate ceramic blocks comprised of -TCP and hydroxyapatite (Triosite) in 58 patients with idiopathic scoliosis. Porous Beta-Calcium Pyrophosphate as a Bone Graft Substitute in a Canine Bone Defect Model. Mulconrey DS, Bridwell KH, Flynn J, Cronen GA, Rose PS. Use of graft materials and biologics in spine deformity surgery: a state-of-the-art review. Allograft is bone that comes from a donorthis type of bone graft is harvested from a cadaver. Peter Whang. Bhatnagar RS, Qian JJ, Wedrychowska A, Smith N. Construction of Biomimetic Environments with A Synthetic Peptide Analogue of Collagen. Meisel HJ, Schnring M, Hohaus C, et al. Since BMPs are soluble proteins and may readily diffuse into the surrounding tissues, away from the site of application, they are used in combination with carriers to maintain effective concentrations at the intended fusion sites. In the control group where local autograft mixed with ceramic bone substitute was used, a 90% radiological fusion rate and 77.77% histological fusion rate was reported. The authors inferred that the use of -TCP appeared to be a valuable alternative to allograft for deformity surgeries where large amounts of bone are required. Putzier M, Strube P, Funk JF, et al. Kadam A, Millhouse PW, Kepler CK, Radcliff KE, Fehlings MG, Janssen ME, Sasso RC, Benedict JJ, Vaccaro AR. Malham GM, Giles GG, Milne RL, Blecher CM, Brazenor GA. Lerner T, Bullmann V, Schulte TL, Schneider M, Liljenqvist U. The substitutes consist of allograft, demineralized bone matrix, polymers, hydroxyapatite, and other materials. Volume 3, Issue 2, March-April 2003, Pages 155-165. 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. 2005;5(6):1-57. Glassman SD. The fusion rate was 82.4% (56 of 68) in the rhBMP-2/ACS group and 78.7% (52 of 66) in the ICBG group (p = 0.782). IL, Comparison of bone grafts for posterior spinal fusion in adolescent idiopathic scoliosis. Demineralized Bone Matrix (DBM); 2. Federal government websites often end in .gov or .mil. Epub 2022 May 16. The sheer volume of literature on rhBMP-2 reflects its acceptance and popularity as a widely used fusion enhancer, as well as the controversial nature of this compound associated with specific complication profiles. HHS Vulnerability Disclosure, Help Niu C-C, Tsai T-T, Fu T-S, Lai P-L, Chen L-H, Chen W-J. Allogenic versus autologous cancellous bone in lumbar segmental spondylodesis: a randomized prospective study. Moon HJ, Kim JH, Kim J-H, Kwon T-H, Chung H-S, Park Y-K. Recombinant BMP-2 applications in the cervical region can be broadly grouped into anterior and posterior cervical fusions. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. For the 21 patients in group 1, 18 (85.7%) exhibited bone fusion on the test side, and 19 (90.5%) presented evidence of fusion (assessed by follow-up radiographs and/or computed tomograms) on the control side. In this study involving un-instrumented fusions, radiologic pseudarthrosis was found in 33.3% of treated cervical levels in the allograft-DBM group versus 22% of levels in the autograft group (p = 0.23). In combined single and 2-level procedures, 87% (157/180) of levels achieved solid fusion and 92% (148/161) exhibited range of motion less than 3 at 24 months. OShaughnessy BA, Kuklo TR, Ondra SL. Although the effect of the platelet concentrate was positive in patients with degenerative disc disease twelve weeks after treatment, the effect did not appear to extend to other follow-up intervals or to patients with soft disc herniations, in whom a detrimental effect was observed. Mummaneni P V, Pan J, Haid RW, Rodts GE. The spinal fusion segment held the largest revenue share of over 60.0% in 2021. A comparison of fresh, fresh-frozen and irradiated bone. Bone graft substitutes for spine fusion: A brief review. Niu et al.94 (level I) evaluated fusion rates using autogenous laminectomy bone chips and calcium sulfate pellets (Osteoset) augmented with bone marrow aspirates in a prospective randomized study of single-level lumbar posterolateral fusions involving 43 patients. In vivo mechanisms of hydroxyapatite ceramic degradation by osteoclasts: fine structural microscopy. James J. Benedict has a financial interest in Cerapedics, Inc. in the form of common stock. Synthetic bone graft extenders; 3. Autologous growth factor use in either lumbar or cervical spine fusions is not endorsed by the majority of the currently available level I and level II studies. A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: report on safety and feasibility. Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery. 8600 Rockville Pike Sardar Z, Alexander D, Oxner W, et al. Consequently, according to biological and biomechanical properties of autograft, spinal posterior arthrodesis is better enhanced by cancellous autograft, whereas anterior interbody tricortical bone is more suitable for anterior fusion. Age, length of fusion, location, and concurrent diseases should be definitive for fusion outcome; papers on spinal arthrodesis should neatly stratify these variables. Fusion is the most common technique in spine surgery and is used. The remaining studies in this sub-group (level III49, 50, 56, 59, 60 and IV51, 52, 55, 57, 58) similarly provide supportive data for the use of DBM as a graft expander in lumbar fusion surgery. Eastlack RK186 evaluated the use of Osteocel Plus cellular allograft for the anterior cervical discectomy and fusion of 249 levels in 182 patients (level IV). The fusion rate of calcium sulfate with local autograft bone compared with autologous iliac bone graft for instrumented short-segment spinal fusion. Bone graft substitutes are other choices. Data on the use of AGFs is limited to a double-blind randomized study181, wherein 50 patients with either degenerative disc disease or soft herniated cervical discs underwent anterior cervical fusion with allograft bone and internal fixation with or without platelet concentrates. In another prospective semi-randomized comparative study, Suchomel et al.8 (level II) evaluated freeze-dried fibular allografts versus autologous iliac crest grafts in 80 patients undergoing instrumented anterior cervical fusions. After 6 months, CHA produced a comparable result to laminectomy-derived bone when combined with iliac crest autograft (group 2) (p = 0.097). The utilization of bone graft substitutes, either as (1) an extender for spinal fusion constructs or (2) an alternative to minimize morbidity while maximizing outcomes, is changing. Martin GJ, Haid RW, MacMillan M, Rodts GE, Berkman R. Anterior cervical discectomy with freeze-dried fibula allograft. Factors affecting bone graft incorporation. Allografts in combination with bone marrow aspirates have shown good fusion efficacy for posterolateral lumbar fusions in two recently published level II studies. All clinical studies reporting radiological and/or patient outcomes following the use of bone substitutes were reviewed under the broad categories of Allografts, Demineralized Bone Matrices (DBM), Ceramics, Bone Morphogenic proteins (BMPs), Autologous growth factors (AGFs), Stem cell products and Synthetic Peptides. rhBMP-6 stimulated osteoprogenitor cells enhance posterolateral spinal fusion in the New Zealand white rabbit. Use of Nanocrystalline Hydroxyapatite With Autologous BMA and Local Bone in the Lumbar Spine: A Retrospective CT Analysis of Posterolateral Fusion Results. Two level III reports explored the use of DBM in scoliosis patients. Sys J, Weyler J, Van Der Zijden T, Parizel P, Michielsen J. Platelet-rich plasma in mono-segmental posterior lumbar interbody fusion. sharing sensitive information, make sure youre on a federal In simplest terms, the goal of a spinal fusion is to fuse 2 spinal bones (vertebrae) together, creating 1 solid bone and restoring spinal stability or restoring alignment. To date, autologous graft is the only biological substance demonstrated to possess osteogenic properties. The .gov means its official. Surgical results with the use of Silicated Calcium Phosphate (SiCaP) as bone graft substitute in Posterior Spinal Fusion (PSF) for Adolescent Idiopathic Scoliosis (AIS). Lindley TE, Dahdaleh NS, Menezes AH, Abode-Iyamah KO. Our findings illustrate that, while many bone graft substitutes perform well as bone graft extenders, only osteoinductive proteins (recombinant bone morphogenetic proteins-2 and osteogenic protein-1) provide evidence for use as both bone enhancers and bone substitutes for specific types of spinal fusion. However, complications related to harvesting procedure and donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be . Reports on the use of DBM in the cervical spine along with PEEK cages similarly suggest that DBM is an acceptable alternative to autologous bone (level II, III and IV data). Vaccaro AR, Stubbs HA, Block JE. Basic knowledge has been achieved from animal experiments, and clinical application of the findings to humans should be done very cautiously; in any case, both anterior and posterior arthrodesis must be protected with instrumentation used according to appropriate biomechanical principles. Cunningham BW, Atkinson BL, Hu N, et al. At this stage, these technologies have only shown promise in animal studies, but they may offer a peek into whats on the horizon for spinal fusion bone grafting. Hydroxyapatite (HA) use in lumbar and cervical spine fusions was not well endorsed by higher evidence level studies, although level III and level IV studies reported good outcomes. PMC legacy view Kanter AS, Gandhoke GS, Welch WC, Arnold PM, Cheng JS, Okonkwo DO. No complications were reported in the study. The procedure of anterior lumbar interbody fusion (ALIF) is commonly performed on patients suffering from pain and/or neurological symptoms associated with disorders of the lumbar spine caused by disc degeneration and trauma. Villavicencio AT, Burneikiene S, Nelson EL, Bulsara KR, Favors M, Thramann J. Before A single level II prospective study by An et al.43 evaluated the use of DBM (Grafton DBM) in combination with allograft for cervical disc disease. The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers. Smucker JD, Bobst JA, Petersen EB, Nepola JV, Fredericks DC. Federal government websites often end in .gov or .mil. The use of freeze-dried fibular allograft in anterior cervical fusion. version.2022.01.01-2022.01.01, Allograft: Cadaver Bone from a Tissue Bank, ACDF: Anterior Cervical Discectomy and Fusion, Postoperative Care for Spinal Fusion Surgery, Spinal Fusion Surgery Recovery: 1 to 3 Months After, Spinal Fusion Surgery Recovery: 3 Months and After, Long Term Relief from Lumbar Spinal Stenosis Pain, The Inova Neuroscience and Spine Institute. However, DBM isnt strong enough to promote bone fusion by itself, so its typically combined with other grafts. Baskin et al.142 (level I) compared the safety and effectiveness of Infuse (rhBMP-2 / ACS) with AICBG placed inside a fibular allograft in a prospective, randomized, clinical pilot trial of anterior cervical discectomy with instrumented interbody fusion. Preliminary study showing safety/efficacy of nanoss bioactive versus vitoss as bone graft expanders for lumbar noninstrumented fusions. Vaccaro AR, Whang PG, Patel T, Phillips FM, Anderson DG, Albert TJ, Hilibrand AS, Brower RS, Kurd MF, Appannagari A, Patel M, Fischgrund JS. Lee JH, Lee DH, Ryu HS, Chang B-S, Hong KS, Lee CK. 2022 Oct 25;11(21):6279. doi: 10.3390/jcm11216279. Bone graft material can be used to fill in gaps at the site of spinal fusion surgery. If taken from the pelvis, this also ups the cost of your surgery and can result in more post-operative pain. The bone graft does not form a fusion at the time of the surgery. Spinal fusion's purpose is to link or weld bones together, in this case, the spinal bones. Biologic bone graft materials continue to be an important component of various spinal fusion procedures. There are now multiple commercially available bone graft substitute options available. Bone Morphogenetic Proteins in Spinal Surgery: What Is the Fusion Rate and Do They Cause Cancer? Burkus JK, Heim SE, Gornet MF, Zdeblick TA. MeSH DBM comes in a variety of formspowder, granules, putty, gel, chipand its processed nature makes it low risk from a disease transmission perspective. Although initial clinical reports are promising, no recommendations can be made currently based on the limited data available regarding the use of B2A in spine surgery. Efficacy of silicate-substituted calcium phosphate ceramic in posterolateral instrumented lumbar fusion. However in another level II study by Jenis et al.175 autologous growth factors combined with an allograft carrier was shown to be equivalent in radiographic and clinical outcomes to autograft (89 vs. 85% fusion rates, respectively) in one or two-level instrumented lumbar interbody fusions. In 20 patients, iliac crest bone graft (ICBG) harvesting was performed whereas the other half received -TCP (Vitoss) augmenting local bone graft. Biochemical properties of cortical allograft bone using a new method of bone strength measurement. In a level II study, Muschik et al.79 evaluated the utility of -TCP (ChronOS) in a granular form to achieve dorsal spondylodesis in 28 patients with AIS. Mean fusion time was 11 days shorter in the rhBMP-2/ACS group than in the ICBG group (p = 0.034). Some major spine fusions need a lot of bone graft. Full PDF Package Download Full PDF Package. These options have attempted to promote spine fusion by enhancing osteogenic properties. The use of rhBMP-2 in the treatment of pyogenic vertebral osteomyelitis is a relatively novel application. Allografts do not form new bone the way autograft does as this bone does not have any bone forming cells that are alive." Arthrodesis rates evaluated using plain radiographs and computed tomographic scans at 6-month, 1-year, and 2-year time points were 86% for the DBM group versus 92% for the autograft group (p = 1.0). Over time, results with rhBMP-2 have been . Allograft This is bone graft material that is donated from another source, typically a cadaver. However their complication profile, which was beyond the scope of discussion of this review, as well recent studies re-evaluating the risks/benefits with BMP use, require physicians to reconsider their routine application in spinal fusion procedures. Hoffmann MF, Jones CB, Sietsema DL. The surgery is done from the front of the body. Bone morphogenetic proteins (BMPs) are in use in spinal surgery, but their exact role with respect to type, dose, and carrier, together with their cost-effectiveness, need further clinical delineation. Keywords: Hyun SJ, Yoon SH, Kim JH, Oh JK, Lee CH, Shin JJ, Kang J, Ha Y. J Korean Neurosurg Soc. Chang KE, Mesregah MK, Fresquez Z, Stanton EW, Buser Z, Wang JC. Multilevel cervical fusion without plates, screws or autogenous iliac crest bone graft. The In another level II study, Singh et al.119 reported an overall 97% fusion rate in the rhBMP-2 group (12 mg dose) compared to a 77% fusion rate with ICBG alone (p < 0.05) for instrumented posterolateral fusions. A prospective randomized trial. Allografts are primarily osteoconductive with minimal osteoinductive potential, but because the donor cells are eradicated during tissue processing, this material is not considered to be osteogenic. Govender S, Kumar KPS. Efficacy of i-Factor. This manuscript intends to provide a review of clinically relevant bone substitutes and bone expanders for spinal surgery in terms of efficacy and associated clinical outcomes, as reported in contemporary spine literature. The authors concluded that the ABM/P-15 composite demonstrated promising results for achieving fusion in patients who undergo ALIF for degenerative spinal diseases.196. In another level I study, Thalgott et al.22 reported that, compared to frozen femoral ring allografts (FRAs), use of freeze dried FRAs for circumferential instrumented lumbar fusion was associated with a higher likelihood of pseudarthrosis (radiographic fusion rates 65.38% vs. 76.67% respectively assessed by periodic AP and lateral radiographs and CT at final follow-up) (p = 0.026). The effect of bone graft extenders to enhance the performance of iliaccrest bone grafts in instrumented lumbar spine fusion. A literature review evaluating available bone graft options assessed within the clinical setting focuses on the contentious use of recombinant human bone morphogenetic proteins, which is in widespread use and has demonstrated both significant osteogenic potential and risk of complications. Kumar A, Kozak JA, Doherty BJ, Dickson JH. Epstein NE, Epstein JA. An official website of the United States government. Park DK, Kim SS, Thakur N, Boden SD. Use of folded vascularized rib graft in anterior fusion after treatment of thoracic and upper lumbar . The added time and cost involved in obtaining growth factor concentrates intra-operatively further weaken the case for AGFs as a suitable bone graft expander. An understanding of the available fusion options and an organized evidence-based approach to their use in spine surgery is essential for achieving optimal results. Fusion rates and SF-36 outcomes after multilevel laminectomy and noninstrumented lumbar fusions in a predominantly geriatric population. All articles reported results on patients who underwent a single- or double-level ACDF performed using a bone graft substitute and reported results on radiographic fusion rates at least 6 months after surgery. In a retrospective study Weinzapfel et al.61 compared fusion rates between allograft bone and DBM (Grafton DBM) following video-assisted thoracoscopic surgery for idiopathic scoliosis. This was in contrast to the results reported in a previous prospective randomized pilot study involving 36 patients, by the same group of authors.164 Fusion rates reported in this study were 63% in the OP-1 group and 67% in the autograft group (p = 0.95), with no significant differences in Oswestry scores between the two (p = 0.56). Patients were observed clinically and radiologically for a minimum of 20 months postoperatively, with a mean follow-up of four years. Authors Ashim Gupta 1 , Nitin Kukkar 1 , Kevin Sharif 1 , Benjamin J Main 1 , Christine E Albers 1 , Saadiq F El-Amin Iii 1 Affiliation Studies in animal populations and experimental in vitro studies were excluded. The best radiological fusion rates were obtained with pure autologous iliac crest graft (95%). Fusion is the most common technique in spine surgery and is used to . A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion. Medicaid PacificSource Medicaid follows Guideline Notes 37, 100, 101, 136, & 137 of the OHP Prioritized List of Health Services for coverage of Bone Graft Substitutes used for Spinal Fusion. Osteogenic Protein-1, also known as rhBMP-7, is the only other member of the BMP family whose clinical application has been studied and published in human subjects. Ghaffarpasand F, Dehghankhalili M, Shahrezaei M. The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study. Mashoof AA, Siddiqui SA, Otero M, Tucci JJ. Bone Graft Substitutes Market: Key Findings Bone graft substitutes are gaining traction, owing to their several properties that make them suitable for use as bone graft extenders,. Spine (Phila Pa 1976). Spine surgeons use a bone graft to: Stop motion between two or more vertebrae. Effect of autologous platelet gel on early and late graft fusion in anterior cervical spine surgery. Deerfield, Special proteins or stem cell modifiers called bone morphogenic protein (BMP). 2022 Aug 25;14(3):37576. doi: 10.52965/001c.37576. These can be broadly grouped according to use into lumbar inter-body fusion or posterolateral fusion. Spine J. Both the study and the control group had similar improvement in all outcome scales (VAS pain, pain drawing, ODI, pain medication use, and opinion of treatment success) and neurological recovery over the 2- to 3-year follow-up period. Schizas C, Triantafyllopoulos D, Kosmopoulos V, Tzinieris N, Stafylas K. Posterolateral lumbar spine fusion using a novel demineralized bone matrix: a controlled case pilot study. The use of osteoconductive stem-cells allograft in lumbar interbody fusion procedures: an alternative to recombinant human bone morphogenetic protein. The ceramic granules used in Amplex have been FDA cleared for bone graft applications in the skeletal system. Common sources include the pelvis, legs, and other parts of the spinal column. Autologous and allogenic bone grafts, ceramics, DBMs and polylactic acids are other substrates that have been utilized for rhBMP delivery. http://www.ncbi.nlm.nih.gov/pubmed/19487515. Kris Radcliff reportsstock ownership and acting as scientific advisor to 4Web Medical; board membership in ACSR; travel expenses and other financial or material support from Altus Spine; paid consultancy and research support from DePuy, IP royalties, paid consultancy, research support from Globus Medical; unpaid consultancy for LDR; paid consultancy and research support from Medtronic, other financial or material support from NEXXT Spine and Nuvasive; paid consultancy other financial or material support, and travel expeses from Orthofix; IP royalties and paid consultancy from Orthopedic Sciences; research support from Pacira Pharmaceuticals, research support from Paradigm Spine; and other financial or material support from Stryker. These approaches pose limitations and present complications to the patient. No level I or level II studies were found describing the use of allografts in deformity correction surgery. He received his Diplomate from the American Board of Chiropractic Orthopaedists during this time. Long adult spinal deformity fusion to the sacrum using rhBMP-2 versus autogenous iliac crest bone graft. National Library of Medicine 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. Patients were randomly assigned to fusion with -TCP (BioLu) combined with local bone obtained from the decompression (n = 32) or autologous iliac crest graft (n=30). Autologous bone has long been regarded as the gold standard for obtaining reliable spinal fusion, mainly because of its distinctive micro-architecture and biological properties, which provide the perfect blend of osteoconductive, osteoinductive and osteogenic elements. Jorgenson SS, Lowe TG, France J, Sabin J. They are used as bone graft substitutes due to their osteoconductive properties, which provide an inert scaffold for fusion to occur. In a level III retrospective study, Hyoungmin et al.84 concluded that porous hydroxyapatite bone chips (Bongros HA) were valuable bone graft extenders in PLIFs when used in conjunction with local bone. 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