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. Michielsen J, Sys J, Rigaux A, Bertrand C. The effect of recombinant human bone morphogenetic protein-2 in single-level posterior lumbar interbody arthrodesis. Thaler M, Lechner R, Gstttner M, Kobel C, Bach C. The use of beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute in posterior lumbar interbody fusion. Significantly lower fusion rates were reported in the study group (74.6 %) compared to the control group (92.5%) where APC was not added (p = 0.021). 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 d. 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). What bone graft substitutes should we use in post-traumatic spinal fusion? These grafts show promise operating as a scaffold (providing a framework for bone growth), but they cant stimulate bone growth on their own. The material properties of hydroxyapatite are similar to other ceramics; however, compared to the more porous tricalcium phosphate scaffolds, HA products are relatively inert and take longer for biodegradation and resorption.81. Table 1 Bone substitutes resuming. 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. Case reports and small case series (n<10) were not reviewed. advertisement Demineralized Bone Matrix (DBM) SF-36 outcomes and fusion rates after multilevel laminectomies and 1 and 2-level instrumented posterolateral fusions using lamina autograft and demineralized bone matrix. Autograft (your own bone) and allograft (donor bone) are 2 types your surgeon may use during spinal fusion surgery. official website and that any information you provide is encrypted Level IV publications on a pilot study by Vaccaro et al.169171 support the safety of OP-1 putty when used as an adjunct to autogenous iliac crest bone graft in uninstrumented posterolateral fusions for degenerative spondylolisthesis. Spine surgeons use a bone graft to: Stop motion between two or more vertebrae. The number of levels fused per case did not have any significant effect on outcome measures. Recent findings: The characterization of BMPs in . However the brittle nature and low shear strength of ceramic grafts limit their use as a standalone bone substitute. Based on the available data, BMP is however associated with the highest radiographic fusion rate. Anterior cervical plating enhances arthrodesis after discectomy and fusion with cortical allograft. iliac crest, ribs, local bone source) Acebal-Cortina G, Surez-Surez MA, Garca-Menndez C, Moro-Barrero L, Iglesias-Colao R, Torres-Prez A. McAnany SJ, Ahn J, Elboghdady IM, et al. It has been used in dental applications for over a decade and has recently been adopted for use in the spine. 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. Allograft This is bone graft material that is donated from another source, typically a cadaver. A PubMed search of English-language articles published through March 2016 was performed. 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. Osteocel plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study. Ceramic-based substitutes and synthetic bone graft extendersCeramics, calcium sulfate, calcium phosphate, and other synthetic bone graft extenders are common bone graft substitutes. However, there were no significant improvements in clinical outcomes in the rhBMP-2 group. 45 Another available option is the use of a demineralized bone matrix as a bone graft extender instead of the bone graft substitute. While the benefits of autograft are numerous and hard for bone graft substitutes to replicate, there are some drawbacks. Over time, results with rhBMP-2 have been . All rights reserved. Demineralized bone matrix (DBM) is derived from human allograft bone. These are stem-cell-based allografts which retain their native bone-forming cells, including mesenchymal stem cells and osteoprogenitor cells, along with bone matrix components. HHS Vulnerability Disclosure, Help Buttermann GR. View. Burkus JK, Sandhu HS, Gornet MF, Longley MC. KnowYourBack.org by the North American Spine Society. Wu MH, Lee MH, Wu C, Tsai PI, Hsu WB, Huang SI, Lin TH, Yang KY, Chen CY, Chen SH, Lee CY, Huang TJ, Tsau FH, Li YY. This site needs JavaScript to work properly. More than a third of the studies (62 studies, 34.25%) were related to the use of Bone Morphogenic Proteins (BMP), making this the single largest group of published bone graft substitutes. J Spinal Disord. The substitutes consist of allograft, demineralized bone matrix, polymers, hydroxyapatite, and other materials. Comparative study of clinical outcomes of anterior cervical discectomy and fusion using autobone graft or cage with bone substitute. An official website of the United States government. 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. The authors wish to thank Robin Hashimoto, PhD, and Joseph R. Dettori, PhD, MPH for their assistance in the preparation of this manuscript. These were further grouped depending on their application in lumbar and cervical spine surgeries, deformity correction or other miscellaneous procedures viz. In a prospective series of 36 patients Finkelstein et al.37 (level IV) reported that the use of cortical strut allografts along with instrumented stabilization was a safe and viable alternative to tri-cortical iliac crest autograft, in terms of radiological fusion outcomes (81% radiologic fusion rate for allografts, no comparator group) for the treatment of thoracolumbar fractures. 2015 Jul 18;6 (6):449-56. doi: 10.5312/wjo.v6.i6.449. All studies using BMP showed 100% fusion rate despite length of the study or whether additional bone graft substitutes were used. No level I studies could be identified in this subgroup. Many spinal conditions cause instability and/or pain (eg, degenerative disc disease, scoliosis, trauma) and require treatment with a spinal fusion. a number of studies have demonstrated excellent fusion rates and clinical outcomes with the use of iliac crest bone autograft (icbg) in both lumbar and cervical fusion procedures. Aurori BF, Weierman RJ, Lowell HA, Nadel CI, Parsons JR. Pseudarthrosis after spinal fusion for scoliosis. Please enable it to take advantage of the complete set of features! 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. Primary endpoints were radiological fusion rates and successful clinical outcomes. Adjuncts in posterior lumbar spine fusion: comparison of complications and efficacy. 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. Graft compositesA bone graft composite is the combination of substances to achieve the greatest bone fusion success. Bone Graft Substitute. Data on the application of HA to scoliosis surgery is also limited to a single case series. Aryan HE, Lu DC, Acosta FL, Ames CP. 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. Thalgott JS, Giuffre JM, Fritts K, Timlin M, Klezl Z. Instrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix, as an adjunct to autologous bone. Taking bone from your own body means your surgical time can be longer (if it is not taken from the vertebra) because it adds an additional surgical site to your procedure. Platelet Rich Plasma for Traumatic Non-Union Fractures: A Novel butControversial Bone Regeneration Strategy. Your spine surgeon may use 1 type of bone graft or a combination in your surgery. In most cases, bone grafts are used in coordination with instrumentation such as screws and/or rods to provide spinal stability. Muschik M, Ludwig R, Halbhbner S, Bursche K, Stoll T. Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: preliminary results of a prospective clinical study. Although early results suggest efficacy similar to autograft, current data is inadequate to draw conclusions. 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). The https:// ensures that you are connecting to the 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. They are highly osteoconductive, variably osteoinductive and lack osteogenic properties due to the loss of cellular elements during processing to reduce immunogenicity. Curr Drug Deliv. This study aimed to evaluate the efficacy of using demineralized bone matrix (DBM) as a substitute of AIBG for long instrumented posterolateral fusion ( three-level fusion). 60015. prime 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). Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions. A variety of DBM preparations have been made commercially available in the form of powders, granules, gels, putties, and strips. 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. rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial. In 2013, Kong et al.65 (level II) reported that the posterolateral fusion rate, using a mixture of -TCP (PolyBone) and local bone, was lower than that for local bone alone (57.1% vs 73.8%) at 12 months follow-up (p = 0.092). There are a variety of spinal conditions cause instability and pain: Degenerative disc disease Scoliosis Trauma from an auto accident, sports injury, slip, and fall accident In a prospective randomized clinical study, Dai et al.63 (level I) reported on 62 patients with symptomatic degenerative lumbar spinal stenosis treated with single-level instrumented posterolateral lumbar fusion, with three years follow-up. The authors found no statistically significant differences in the radiological fusion rates between the two groups (85% with autograft versus 80% with allograft) based on 12 month post-operative radiograph assessment (k = 0.90). Patients were allocated into three groups: laminectomy bone and ICBG (group 1, n = 20), CHA and ICBG (group 2, n = 19), and laminectomy bone and CHA (group 3, n = 19); the respective graft materials were placed in either the right or left inter-transverse space. He then completed a residency in Chiropractic Orthopaedics from the same school and was in private practice for five years. Although bone morphogenetic proteins . Download Download PDF. 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). Spine J. Support of the anterior column with allografts in tuberculosis of the spine. Accessed November 2, 2018. eCollection 2017 Feb 18. Literature on the use of allograft cellular bone matrix/Stem cell based products is currently mostly in the form of level IV studies. Four Level IV studies20, 23, 24, 27 on lumbar interbody fusion, employing either femoral ring or femoral head allografts, similarly demonstrated high radiological fusion rates (ranging from 88 to 98%). Nagineni V V, James AR, Alimi M, et al. Limited available data indicate non-inferiority of ABM/P-15 compared to autograft for single-level cervical fusion surgery. 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. Bhatnagar RS, Qian JJ, Wedrychowska A, Smith N. Construction of Biomimetic Environments with A Synthetic Peptide Analogue of Collagen. No class of bone substitutes/bone graft extenders has been as extensively studied and published as BMPs. Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies. 2008 May-Jun;8(3):457-65. doi: 10.1016/j.spinee.2007.03.012. The effect of bone graft extenders to enhance the performance of iliaccrest bone grafts in instrumented lumbar spine fusion. Reports evaluating the use of DBM in lumbar spine fusions are numerous. The surgeon may also take bone from your spine, known as local autograft. Rihn JA, Makda J, Hong J, et al. 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. Bone graft substitutes for spinal fusion. No complications were reported in the study. "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. Eight level II studies on the use of rhBMP-2 in lumbar spine were identified and reviewed. Disclaimer, National Library of Medicine Suchomel P, Barsa P, Buchvald P, Svobodnik A, Vanickova E. Autologous versus allogenic bone grafts in instrumented anterior cervical discectomy and fusion: a prospective study with respect to bone union pattern. 2017 Feb 18;8(2):87-98. doi: 10.5312/wjo.v8.i2.87. "BMP is a potent molecule and its commercial growth has slowed due to its side effects. In a prospective case control study involving 58 patients with degenerative spinal stenosis, Hsu et al.83 (level II) compared coralline hydroxyapatite (CHA) and laminectomy-derived bone as adjuvant graft materials for posterolateral lumbar fusions. All resulting articles were broadly grouped into the following categories: Allografts, Demineralized bone matrix (DBM), Ceramics, Osteogenic growth factors (namely Bone Morphogenic Proteins), Autologous growth factors (AGFs) (Platelet derived growth factors), Stem cell products (Allograft cellular bone matrix) and Synthetic peptides. https://www.knowyourback.org/KnowYourBack/Treatments/SurgicalOptions/BoneGraftAlternatives. Hart R, Komzk M, Okl F, Nhlk D, Jajtner P, Puskeiler M. Allograft alone versus allograft with bone marrow concentrate for the healing of the instrumented posterolateral lumbar fusion. Christopher Kepler reports no disclosures or conflicts of interest. The bone graft does not form a fusion at the time of the surgery. More recent level III studies6, 7, 9, 10 using instrumentation to augment allograft constructs also reported high fusion rates, ranging from 91.9% to 94.3%. A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion. Fu T-S, Wang I-C, Lu M-L, Hsieh M-K, Chen L-H, Chen W-J. The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis. Iliac crest autograft was implanted on one side of the spine while a DBM (Grafton DBM) and autograft composite was used on the contralateral side in the same patient. Spinal arthrodesis consists of the combination of a hardware system for mechanical stabilisation together with a biological substance for enhancement of bone formation. 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. Fusion on CT scan was ultimately achieved in all patients. Kaiser MG, Haid RW, Subach BR, Barnes B, Rodts GE. 2021 Jul;64(4):562-574. doi: 10.3340/jkns.2020.0331. ABM consists of smooth, porous particles of pure deproteinated hydroxyapatite.190, 192 This bone graft combination of ABM and P-15, also known as i-Factor, is claimed to facilitate bone formation.192 I-Factor is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy. Vaccaro AR, Whang PG, Patel T, et al. Results. Cortical allografts in spinal tuberculosis. 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. Hodges SD, Eck JC, Newton D. Retrospective study of posterior cervical fusions with rhBMP-2. There are discrepancies between the two published level I studies on calcium sulphate use for lumbar spinal fusion, although both utilized the same preparation (Osteoset). The average ODI scores, SF-36 physical component summary scores, and low-back and leg-pain scores were significantly better in the study group (p < 0.05). Hee et al.176 (level II) concluded after a prospective study that autologous growth factors (AGF) in one- and two-level TLIFs did not result in an overall increase in spinal fusion rates compared to autograft, although faster fusions were documented with AGF. No reports were found describing the clinical use of B2A in cervical spine surgery. 46 Ceramic bone graft substitutes have also been tested, but . FOIA Invited submission from the Joint Section Meeting on Disorders of the Spine. A prospective clinical and radiographic 12-month outcome study of patients undergoing single-level anterior cervical discectomy and fusion for symptomatic cervical degenerative disc disease utilizing a novel viable allogeneic, cancellous, bone matrix (tri. Sugawara T, Itoh Y, Hirano Y, Higashiyama N, Mizoi K. -Tricalcium phosphate promotes bony fusion after anterior cervical discectomy and fusion using titanium cages. Use of recombinant human bone morphogenetic protein-2 as an adjunct for instrumented posterior arthrodesis in the occipital cervical region: An analysis of safety, efficacy, and dosing. Based on application, the market is classified into long bone, spinal fusion, foot and ankle, joint reconstruction, craniomaxillofacial, and dental. For Group 3, the fusion rate (57.9%) was markedly lower than that in Groups 1 and 2 (90.0 and 78.9%, respectively). 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. There were no significant differences in recovery rates using the SF-36 and Japanese Orthopedic Association ( JOA) scores at all time intervals. 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. There are several types of bone graft substitutes used in spinal fusions: 1. Vaccaro reports other from Replication Medica, personal fees from DePuy, personal fees from Medtronics, personal fees from Stryker Spine, personal fees and other from Globus, other from Paradigm Spine, personal fees and other from Stout Medical, other from Progressive Spinal Technologies, other from Advanced Spinal Intellectual Properties, personal fees from Aesculap, other from Spine Medica, other from Computational Biodynamics, other from Spinology, other from In Vivo, other from Flagship Surgical, other from Cytonics, other from Bonovo Orthopaedics, other from Electrocore, other from Gamma Spine, other from Location Based Intelligence, other from FlowPharma, other from R.S.I., personal fees from Gerson Lehrman Group, from Guidepoint Global, personal fees from Medacorp, other from Rothman Institute and Related Properties, other from AO Spine, personal fees and other from Innovative Surgical Design, other from Association of Collaborative Spine Research, personal fees from Orthobullets, personal fees from Thieme, personal fees from Jaypee, personal fees from Elsevier, personal fees from Taylor Francis/Hodder and Stoughton, personal fees from Expert Testimony, personal fees from Ellipse, personal fees from Vertex, personal fees from Avaz Surgical, other from Clinical Spine Surgery, outside the submitted work. Introducing levels of evidence to the journal. Accessed November 2, 2018. More better quality studies are required comparing these substitutes and extenders not just with autografts, but also with each other. Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery. 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). RhBMP-2 is superior to iliac crest bone graft for long fusions to the sacrum in adult spinal deformity: 4- to 14-year follow-up. Two-level contiguous cervical disc disease treated with peek cages packed with demineralized bone matrix: results of 3-year follow-up. Millhouse reports stock ownership in Globus Medical, outside the submitted work. 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. Comparative Analysis of ABM/P-15, Bone Morphogenic Protein and Demineralized Bone Matrix after Instrumented Lumbar Interbody Fusion. 2019 Jun 11;14:4333-4351. doi: 10.2147/IJN.S209431. Barbanti Brodano G, Griffoni C, Zanotti B, Gasbarrini A, Bandiera S, Ghermandi R, Boriani S. Eur Rev Med Pharmacol Sci. sharing sensitive information, make sure youre on a federal Volume 3, Issue 2, March-April 2003, Pages 155-165. 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. Hydroxyapatite is a naturally occurring mineral found in bones and is estimated to contribute up to 50% of the bone by mass.80 Coralline hydroxyapatite, as the name suggests, is synthesized from sea corals. Would you like email updates of new search results? Twelve publications1829 including two level I21, 22 and four level II18, 19, 25, 26 studies were found reporting the use of allograft in the lumbar spine. Please enable it to take advantage of the complete set of features! Vaccaro AR, Whang PG, Patel T, Phillips FM, Anderson DG, Albert TJ, Hilibrand AS, Brower RS, Kurd MF, Appannagari A, Patel M, Fischgrund JS. There are potential risks of using BMP, so the surgeon needs to have experience with this substance. Preliminary study showing safety/efficacy of nanoss bioactive versus vitoss as bone graft expanders for lumbar noninstrumented fusions. +: the material has this property. Use of autologous growth factors in lumbar spinal fusion. Murphy RF, Glotzbecker MP, Hresko MT, Hedequist D. Allograft Bone Use in Pediatric Subaxial Cervical Spine Fusions. Khajavi K, Shen A. Overview of 317 cases and literature review. Higher physical function scores were observed in the DBM group at 2 year follow-up, although this also was not statistically significant. Delcrin J, Takahashi S, Gouin F, Passuti N. A synthetic porous ceramic as a bone graft substitute in the surgical management of scoliosis: a prospective, randomized study. rhBMP-6 stimulated osteoprogenitor cells enhance posterolateral spinal fusion in the New Zealand white rabbit. Ceramics appear to be a promising group of bone graft extenders, especially when combined with bone marrow aspirates. Disclaimer, National Library of Medicine Furlan et al.168 reported good fusion rates (80%) and improved health related quality of life (HRQOL) outcomes in a level III study using OP-1 and autograft in 30 patients with high risk of spinal pseudarthrosis. Jenis LG, Banco RJ. Although CBMs appear to be safe for use as bone graft substitutes, their efficacy in spinal fusion surgery remains highly inconclusive. Lauweryns et al.191 (level III) reported on a prospective clinical and radiological analysis of patients undergoing a PLIF procedure, comparing ABM/P-15 to local autograft. More comparative studies are needed to evaluate the efficacy of bone graft substitutes overall. Radiological fusion was achieved at 1 year postoperatively in all groups and vertebral segments. To prevent disease transmission, allograft bone is thoroughly disinfected. Mummaneni P V, Pan J, Haid RW, Rodts GE. Jarcho M. Calcium phosphate ceramics as hard tissue prosthetics. 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 Medical research continues to design bone graft substitutes, chemicals, and devices that stimulate the bones to fuse. World J Orthop. Hamilton DK, Jones-Quaidoo SM, Sansur C, Shaffrey CI, Oskouian R, Jane JA. Allografts do not form new bone the way autograft does as this bone does not have any bone forming cells that are alive." Grossman W, Peppelman WC, Baum JA, Kraus DR. Joel Finkelstein. Allografts in combination with bone marrow aspirates have shown good fusion efficacy for posterolateral lumbar fusions in two recently published level II studies. James J. Benedict has a financial interest in Cerapedics, Inc. in the form of common stock. Enhanced cell attachment to anorganic bone mineral in the presence of a synthetic peptide related to collagen. 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). Fusion was assessed using plain-films and CT scans for bone formation in the arthrodesed interbody spaces. Dai L-Y, Jiang L-S. Anterior cervical fusion with interbody cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up. Bone grafts and bone substitutes are indispensable for achieving and maintaining fusion and intersegmental stability in spine surgery. Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Kanter AS, Gandhoke GS, Welch WC, Arnold PM, Cheng JS, Okonkwo DO. Spinal fusion's purpose is to link or weld bones together, in this case, the spinal bones. The basic idea of spinal bone graft fusion is to fuse two painful bones in the spine. Tumialn LM, Pan J, Rodts GE, Mummaneni P V. 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. Prospective comparison of autograft vs. allograft for adult posterolateral lumbar spine fusion: differences among freeze-dried, frozen, and mixed grafts. The fusion rate of demineralized bone matrix compared with autogenous iliac bone graft for long multi-segment posterolateral spinal fusion. In this prospective, case matched study, the authors concluded that -CPP combined with autograft was as effective as autologous bone for instrumented posterolateral interbody fusions. The clinical use of ACBM products has been reported for lumbar spine fusions in five case series (level IV) publications.182186 Three of these reported on the use of a commercially available product Osteocel Plus (NuVasive Inc., San Diego, CA) whereas one study185 used enriched autologous mesenchymal stem cells (MSCs) harvested from iliac crest bone marrow in combination with porous -TCP granules. Augmenting local bone with Grafton demineralized bone matrix for posterolateral lumbar spine fusion: avoiding second site autologous bone harvest. PMC 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. A total of 181 articles met the inclusion criteria (Allograft: 39, DBM: 20, Ceramics: 40, rhBMP-2: 54, rhBMP-7/OP-1: 8, Autologous growth factors: 9, Stem cells based products: 7, Synthetic Peptides 4). Hurlbert RJ, Alexander D, Bailey S, et al. Rather, it provides a framework for the new bone to grow through like a scaffold to allow the bone cells to grow. New Technology for a Bone Graft. A level-1 pilot study to evaluate of ultraporous beta-tricalcium phosphate as a graft extender in the posterior correction of adolescent idiopathic scoliosis. 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) DBM comes in a variety of formspowder, granules, putty, gel, chipand its processed nature makes it low risk from a disease transmission perspective. Yamada et al.64 conducted a prospective comparative study (level II) in 61 consecutive patients undergoing decompressive laminotomy and single level instrumented posterolateral fusion. Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies. Many bone graft substitutes, however, are not structural and need to be combined with a manufactured device that holds it . will also be available for a limited time. Guth K, Buckland T, Hing KA. Allograft use for posterior cervical fusion, especially occipito-cervical fusions has been evaluated in level III and level IV studies.5, 6 Good fusion rates ranging from 89.9%6 to 95%5 were reported. 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. A radiological fusion rate of 97.5% was reported. Unable to load your collection due to an error, Unable to load your delegates due to an error. Longer term, additional market opportunities . Autograft, although mired by issues such as donor site morbidity and limited availability, remains the gold standard for spinal fusion. In subjects treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3. 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. Peter Whang. The combined use of bioactive peptides and porous implants or materials has led to a new generation of fusion extenders.189 Perhaps the most well-known, P-15 is a 15-residue synthetic polypeptide which acts as a binding factor for osteogenic cells on a domain of type I collagen.190, 191 The P-15 peptide has been studied in a variety of animal models and is reported to enhance cell migration, induce osteoblast differentiation, and influence a pathway which results in new bone formation.192, 193 P-15 gained FDA approval for the treatment of intrabony periodontal osseous defects due to moderate or severe periodontitis. Prospective analysis of a new bone graft in lumbar interbody fusion: results of a 2- year prospective clinical and radiological study. Theyve also been shown to reduce adverse reactions to allograft and bone graft substitutes. Today, human bone autografts and allografts are the most common bone graft options for spinal fusion patients. The role of Osteocel Plus as a fusion substrate in minimally invasive instrumented transforaminal lumbar interbody fusion. Autograft bone graft is taken from your own body, most likely from your hip (really the pelvis), ribs, or leg. Autologous iliac crest (AIC) graft has been considered the gold standard treatment for spinal fusion because of its histocompatible and non-immunogenic properties, presenting higher amounts. However, these products do not have all the properties necessary to stimulate a spinal fusion when used alone. Beta-Tricalcium Phosphate (-TCP), Hydroxyapatite (HA), Calcium Sulphate and more recently Silicate-Substituted Calcium phosphate (Si-CaP) and Calcium pyrophosphate (-CPP) are among the most notable ceramic scaffolds that have been studied for use in human spinal fusions. 2022 Nov;10(6):1217-1231. doi: 10.1007/s43390-022-00529-1. However, no comparison with autograft was done by the authors in the study. -Multiple level spinal fusion Enhancer -To improve success of autogenous bone graft Substitute -To replace autogenous bone graft. Moon HJ, Kim JH, Kim J-H, Kwon T-H, Chung H-S, Park Y-K. For this reason there exists a significant amount of interest in bone graft substitutes and enhancers to improve clinical outcomes for these patients. The authors recommended avoiding the use of -TCP due to high pseudoarthrosis rates. Bone graft substitutes are widely used in the field of orthopedics and are extensively used to promote vertebral fusion. 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. Kim HJ, Buchowski JM, Zebala LP, Dickson DD, Koester L, Bridwell KH. Between 1960 and 2000, many advances were made, specifically in the use of bone graft substitutes. Level IV retrospective studies by Jenis et al.102 and Nagineni et al.103 reported fusion rates from 76.5% to 90% with the use of Si-Cap in cervical and lumbar fusion procedures. 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. Price et al.62 also related comparable fusion and failure outcomes for a composite of DBM and autologous bone marrow versus iliac crest autograft in adolescent idiopathic scoliosis. 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. A Medline search of English language literature published through March 2016 discussing bone graft substitutes and fusion extenders was performed. Autograft and allograft are currently the most frequently used bone graft types for spinal fusion surgery, but new biomedical materials are advancing the case for bone graft substitutes. Efficacy of calcium sulfate plus decompression bone in lumbar and lumbosacral spinal fusion: preliminary results in 40 patients. No published level I studies reported on the use of -TCP in cervical fusions. In 20 patients, iliac crest bone graft (ICBG) harvesting was performed whereas the other half received -TCP (Vitoss) augmenting local bone graft. Sardar Z, Alexander D, Oxner W, et al. Spinal Fusion Stimulates New Bone Growth. Advancements and frontiers in nano-based 3D and 4D scaffolds for bone and cartilage tissue engineering. Some major spine fusions need a lot of bone graft. Fusion is the most common technique in spine surgery and is used to treat morbidities and relieve discomfort. Before a two-year follow-up. Wang Z, Sakakibara T, Sudo A, Kasai Y. Porosity of -tricalcium phosphate affects the results of lumbar posterolateral fusion. 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 results were clinically comparable and not significantly different (p = 0.852). Bone Morphogenetic Proteins (BMP) are another type of bone graft option, as detailed on the following page. Interspace distraction and graft subsidence after anterior lumbar fusion with femoral strut allograft. Introduction of technological advancements on the grounds of osteoinductivity, osteoconductivity, osteogenicity, and cost-effectiveness is . In the OP-1 group radiological fusion was seen in 77.77% of the cases, whereas histological assessment of fusion mass in the patients in this group revealed a fusion rate of 57.1%. Mesenchymal stem cell allograft as a fusion adjunct in one- and two-level anterior cervical discectomy and fusion: a matched cohort analysis. Graham RS, Samsell BJ, Proffer A, et al. The use of osteoconductive stem-cells allograft in lumbar interbody fusion procedures: an alternative to recombinant human bone morphogenetic protein. Efficacy of posterior cervical fusions utilizing an artificial bone graft expander, beta tricalcium phosphate. Smucker JD, Bobst JA, Petersen EB, Nepola JV, Fredericks DC. Dr. Corenman started his career as a Doctor of Chiropractic in 1978 after attending California State University at Northridge then receiving a Bachelor of Science degree in Biology and graduating from the Los Angeles College of Chiropractic with a Doctor of Chiropractic degree. Significant improvements in clinical outcome measures were also reported in both groups. A minimum of 1-year follow-up in 144 patients. Bone graft substitutes are widely used in the field of orthopedics and are extensively used to promote vertebral fusion. 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. Veronesi F, Sartori M, Griffoni C, Valacco M, Tedesco G, Davassi PF, Gasbarrini A, Fini M, Barbanti Brodano G. J Clin Med. Furlan JC, Perrin RG, Govender P V, et al. These can be broadly grouped according to use into lumbar inter-body fusion or posterolateral fusion. Dimar JR, 2nd, Glassman SD, Burkus JK, Pryor PW, Hardacker JW CL. Another commercially available ACBM that has been studied and recently quoted is Trinity Evolution (Musculoskeletal Transplant Foundation, Edison, NJ, USA). He received his Diplomate from the American Board of Chiropractic Orthopaedists during this time. Studies in animal populations and experimental in vitro studies were excluded. ALIF, PLIF, TLIF, MIS) has not been investigated in clinical studies. Complications associated with recombinant human bone morphogenetic protein use in pediatric craniocervical arthrodesis. 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. Valdes M, Moore DC, Palumbo M, Lucas PR, Robertson A, Appel J, Ehrlich MG, Keeping HS. Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Orthopedics. A pilot safety and efficacy study of OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions. Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2. Numerous alternative bone graft substitutes are on the market or have been developed and proposed for application. Abhijeet Kadam reports no disclosures or conflicts of interest. 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. 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. The advantages include no risk of disease transmission and ready availability. The type and position of spinal bone grafts affect spinal fusion. As such, DBM can be mixed with regular bone to obtain more graft volume when it is needed for fusion. 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. Use of Recombinant Human Bone Morphogenetic Protein-2 With Local Bone Graft Instead of Iliac Crest Bone Graft in Posterolateral Lumbar Spine Arthrodesis. Ont Health Technol Assess Ser. A similar opinion was echoed by Thaler et al.66 in a series of 34 patients (level IV) using -TCP (ChronOS) in combination with autologous bone marrow aspirate for instrumented posterior lumbar interbody fusion (PLIF). Photo Credit: 123RF.com. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Careers. B2A is another novel synthetic peptide which is similarly purported to increase osteoblast differentiation by interacting with native BMP-2 receptors and amplifying the response to stimulus.194 B2A has osteoconductive and osteoinductive properties and animal model studies have demonstrated its superiority over autograft for achieving spinal fusion.189, 195 BioSET Amplex (Biosurface Engineering Technologies, Rockville, MD) is a commercially available bone graft kit that combines B2A with bi-phasic hydroxyapatite and -tricalcium phosphate granules. Godzik J, Ravindra VM, Ray WZ, Schmidt MH, Bisson EF, Dailey AT. Singh K, DeWald CJ, Hammerberg KW, De-Wald RL. ICD-10-PCS Character 6: Device. The https:// ensures that you are connecting to the Comparison of TLIF with rhBMP-2 versus no TLIF and higher posterolateral rhBMP-2 dose at L5-S1 for long fusions to the sacrum with sacropelvic fixation in patients with primary adult deformity. Uses of this material can be off label or used outside the official use criteria. Epub 2022 May 16. Bookshelf NCI CPTC Antibody Characterization Program. An official website of the United States government. Graft options in posterolateral and posterior interbody lumbar fusion. Only studies reporting radiological fusion rates (assessed using X-rays, CT scans and/or isotope bone scans) and/or clinical patient outcomes following the application of bone substitutes in spine surgery were included. Govender S, Kumar KPS. Allograft use in combination with posterior segmental instrumentation was reported to have acceptable fusion rates (ranging from 70% to 92.7%) and seemed to be an efficacious and safe substitute for autologous bone in several level III30, 31 and level IV studies.3236 In one study however, Demirkiran et al.36 reported high rates of pseudoarthrosis (13.3%) in a series of 15 patients with long segment (>6 level) posterior instrumented fusions, with an overall fusion rate of 86.7% using allograft for instrumented posterior fusions alone. Another novel ceramic substitute, calcium pyrophosphate (-CPP) has shown promising results in animal studies in terms of fusion rates and rapid incorporation and resorption characteristics.106. https://orthoinfo.aaos.org/en/treatment/bone-grafts-in-spine-surgery. Niu C-C, Tsai T-T, Fu T-S, Lai P-L, Chen L-H, Chen W-J. and transmitted securely. A prospective analysis of autograft versus allograft in posterolateral lumbar fusion in the same patient. Eighty-two percent of disc levels in the allograft group and 92% in the DBM group were rated as radiologically fused, suggesting superior results for DBM use in scoliosis. World J Orthop. However allograft use alone for instrumented posterolateral lumbar fusions is not well supported, with two level II studies reporting inferior fusion rates, although there were no differences in clinical outcomes. Use of osteogenic protein-1 in patients at high risk for spinal pseudarthrosis: a prospective cohort study assessing safety, health-related quality of life, and radiographic fusion. 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. Other available Level III74 and level IV75, 76 studies report good efficacy and satisfactory outcomes with -TCP use when compared to autologous bone grafts. However, they may occasionally cause inflammation. Similar to their DBM counterparts, ceramics are mainly used as bone graft extenders in combination with autologous bone or bone marrow aspirates and interbody devices. 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). While bracing is an effective treatment in some cases, 6 progression to more severe AIS is often treated by posterior spinal fusion (PSF). 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 . Finkelstein JA, Chapman JR, Mirza S. Anterior cortical allograft in thoracolumbar fractures. Bone graft substitutes are widely used in the field of orthopedics and are extensively used to promote vertebral fusion. Baskin DS, Ryan P, Sonntag V, Westmark R, Widmayer MA. 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