FOIA Vanichkachorn188 in a prospective series (level IV) of 31 patients undergoing single level ACDF, reported a radiological fusion rate of 93.5% at 12 months follow up. 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. While the benefits of autograft are numerous and hard for bone graft substitutes to replicate, there are some drawbacks. These areas are often created by removing diseased and damaged bones during spinal fusions. Eastlack RK, Garfin SR, Brown CR, Meyer SC. However, bone graft substitutes are widely used and account for more than 2 million surgeries annually worldwide, according to a 2015 review of bone graft substitutes published in World Journal of Orthopedics. Prospective comparison of autograft vs. allograft for adult posterolateral lumbar spine fusion: differences among freeze-dried, frozen, and mixed grafts. 2016 Sep 22;10:33. doi: 10.14444/3033. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion. Bone graft and/or bone graft substitute is needed to create the environment for the solid bridge to form. At 24 months after surgery, 63% of levels in the DBM and bone marrow group, 70% of levels in the DBM and iliac crest group, and 67% in the ICBG group had radiological fusion as evaluated by anteroposterior, lateral and flexion-extension radiographs (p = 0.875). Christopher Kepler reports no disclosures or conflicts of interest. 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) Biochemical properties of cortical allograft bone using a new method of bone strength measurement. 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. Advancements and frontiers in nano-based 3D and 4D scaffolds for bone and cartilage tissue engineering. The use of freeze-dried allograft bone for anterior cervical fusions. Challenges of bone tissue engineering in orthopaedic patients. Use of allograft bone for posterior C1-2 fusion. 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. In this way, they can heal together. Special proteins or stem cell modifiers called bone morphogenic protein (BMP). An HS, Simpson JM, Glover JM, Stephany J. For this reason there exists a significant amount of interest in bone graft substitutes and enhancers to improve clinical outcomes for these patients. 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. 2018 May;10(2):89-97. doi: 10.1111/os.12371. Valdes M, Moore DC, Palumbo M, Lucas PR, Robertson A, Appel J, Ehrlich MG, Keeping HS. Clinical outcomes and fusion rates following anterior lumbar interbody fusion with bone graft substitute i-FACTOR, an anorganic bone matrix/P-15 composite. 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. Malham GM, Giles GG, Milne RL, Blecher CM, Brazenor GA. However, no comparison with autograft was done by the authors in the study. Aurori BF, Weierman RJ, Lowell HA, Nadel CI, Parsons JR. Pseudarthrosis after spinal fusion for scoliosis. Epub 2007 Apr 6. The basic idea is to fuse together painfulor unstable bones in the spine so that they heal into a single, solid bone. Long-term results after anterior cervical discectomy and fusion with allograft and plating: a 5- to 11-year radiologic and clinical follow-up study. However, two recent level II studies18, 19 utilizing allografts in combination with bone marrow aspirate (BMA) reported fusion rates up to 80%18 and equivalence with autologous iliac crest grafts.19. Though efforts to identify the ideal carrier are ongoing, absorbable collagen sponges (ACS) and compression resistant matrix (CRM) are frequently used. Fusion is the most common technique in spine surgery and is used to . The basic idea of spinal bone graft fusion is to fuse two painful bones in the spine. In this study by McConnell et al.87, graft fragmentation occurred in 89% of the hydroxyapatite grafts versus 11% of the autograft (p = 0.001). 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. Rihn JA, Makda J, Hong J, et al. Complications in Spinal Fusion Surgery: A Systematic Review of Clinically Used Cages. For the 22 patients in group 2, 20 (90.9%) exhibited bone fusion on the control side whereas only 10 (45.5%) demonstrated complete fusion on the test side (p < 0.05), where calcium sulfate and BMA was applied. Would you like email updates of new search results? 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. Effect of autologous platelet gel on early and late graft fusion in anterior cervical spine surgery. ACBM is a novel group of bone graft expanders and, similar to autologous bone, are believed to potentially possess all three physiologic properties involved in normal bone healing; namely osteoconduction, osteoinduction, and osteogenesis.182. A combination of failure of the correct graft together with proper instrumentation will result in poorer outcome, even if the right graft is used. Fusion is the most common technique in spine surgery and is used. Radiographic follow-up at 12 months, 24 months, and longer evaluation included standing lateral flexion and extension dynamic studies. Kong S, Park JH, Roh SW. A prospective comparative study of radiological outcomes after instrumented posterolateral fusion mass using autologous local bone or a mixture of beta-tcp and autologous local bone in the same patient. At 12, 18, and 24 months, lateral decubitus flexion-extension films also were included to confirm fusion integrity. Clinical outcomes using the Oswestry low back pain Disability Index (ODI) also demonstrated no significant differences in allograft and autograft groups. 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. 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. Get Veritas Health eNewsletters delivered to your inbox. Clinical outcomes and fusion rates following anterior lumbar interbody fusion with bone graft substitute i-FACTOR . Zdeblick TA, Ducker TB. 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. 2015 Oct;19(19):3548-55. The authors concluded that fusion rates and clinical outcomes associated with DBM for lumbar fusion were comparable to the use of iliac crest autograft. 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). New Technology for a Bone Graft. Lumbar anterior-posterior (AP) and lateral radiograph imaging was done immediately postoperative and at 1, 3, 6 and 12 months. 2005;5(6):1-57. Efficacy of calcium sulfate plus decompression bone in lumbar and lumbosacral spinal fusion: preliminary results in 40 patients. 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. Mean fusion time was 11 days shorter in the rhBMP-2/ACS group than in the ICBG group (p = 0.034). Though level IV data support the use of Si-CaP as a viable alternative to autograft in degenerative lumbar spine fusion and scoliosis surgery, level I studies directly evaluating comparability to autologous bone grafts are not presently available. Radiographic evaluation of fusion was done using periodic radiographs and three dimensional thin cut (1 mm) CT images at 12 months postoperatively. For use in deformity correction, trauma, tumor and infections, the studies are supportive, although of lower quality evidence (mostly level III and IV). A single level I study demonstrated that coralline hydroxyapatite was structurally inferior to iliac crest bone for cervical interbody fusion, although clinical results and fusion rates were similar. The use of rhBMP-2 in the treatment of pyogenic vertebral osteomyelitis is a relatively novel application. Bone Grafts in Spine Surgery. Bone morphogenetic protein-2 (BMP-2) in the treatment of pyogenic vertebral osteomyelitis. 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. Bone graft substitutes such as recombinant human bone morphogenetic proteins (rhBMP-2 and rhBMP-7) have emerged as viable alternatives. Ammerman JM, Libricz J, Ammerman MD. Hamilton DK, Smith JS, Reames DL, Williams BJ, Shaffrey CI. Keywords: Autologous local bone graft harvested during the laminotomy was placed on the contralateral side as control. 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. 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. The viable alternative is allograft and synthetics. 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. Apart from a few papers (level III and IV data) which report encouraging results, most of the available literature fails to demonstrate any significant benefit with AGF use. This site is for educational purposes only; no information is intended or implied to be a substitute for professional medical advice. The growth can be attributed to the rising adoption of bone graft materials for spondylosyndesis. At 24 months follow-up, 81-100% of patients who had undergone 3-, 2- or 1-level procedures exhibited fusion at all levels treated. Cunningham BW, Atkinson BL, Hu N, et al. Dental bone graft substitutes are used mostly in ridge augmentation, implant bone regeneration, sinus lift procedures, periodontal defect regeneration, and socket preservation. rhBMP-6 stimulated osteoprogenitor cells enhance posterolateral spinal fusion in the New Zealand white rabbit. Veronesi F, Sartori M, Griffoni C, Valacco M, Tedesco G, Davassi PF, Gasbarrini A, Fini M, Barbanti Brodano G. J Clin Med. 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). 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). Silicate-substituted calcium phosphate ceramic bone graft replacement for spinal fusion procedures. Bookshelf Another example of therapeutic proteins are bone morphogenetic proteins (BMPs) used in spinal fusions. Real bone refers to bone graft coming from your own body (known as autograft or autogenous) or harvested from a cadaver donor (called allograft). Kaiser MG, Groff MW, Watters WC 3rd, Ghogawala Z, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Sharan A, Wang JC, Dhall SS, Resnick DK. Centrella M, McCarthy TL, Canalis E. Platelet-derived growth factor enhances deoxyribonucleic acid and collagen synthesis in osteoblastenriched cultures from fetal rat parietal bone. Unlike allograft (cadaver bone), ceramic-based products do not present a risk for disease transfer. Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2. Graham RS, Samsell BJ, Proffer A, et al. Orthopaedic Spine Surgeon and Chiropractor, Sciatica Self-care: 5 At-home Remedies for Low Back and Leg Pain, Upper Back Pain Causes, Risk Factors, Diagnosis and Treatment, How to Tell if Your Sciatica is Actually Piriformis Syndrome, Leading Causes of Sciatica and Sciatic Nerve Pain, Spondylosis Symptoms, Causes, Diagnosis and Treatment, 7 Lower Back Pain Causes That Affect Women, Muscle Relaxants for Back Pain and Neck Pain, Herniated Disc: Symptoms, Causes, Diagnosis, and Treatment. Moreover, current procedural technology (CPT) code 20939 became effective in 2018 defining bone marrow aspirate for bone grafting, spine surgery only. Bone Morphogenetic Proteins (BMP) are another type of bone graft option, as detailed on the following page. Because your body is already familiar with the bone, it creates the optimal environment for a healthy bone fusion. 1. Significantly higher fusion rates (99 % vs. 76%) were also reported in the study group (p < 0.001), assessed with radiographs and CT. Slosar et al.118 reported a 100% fusion rate at 24 months follow-up after anterior lumbar interbody fusions using rhBMP-2 and femoral ring allograft. By way of a level II prospective study, Dai et al.72 concluded that interbody fusion cages containing -TCP following one- or two-level discectomy proved to be an effective treatment for cervical spondylotic radiculopathy and/or myelopathy, with successful fusion seen in all patients at 6 months follow-up (p < 0.05), as evaluated using standard AP and lateral flexion-extension radiographs. Some surgeries need large pieces of structural bone graft, which may cause problems in the area of the body where the bone was removed. 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. Baumann F, Krutsch W, Pfeifer C, Neumann C, Nerlich M, Loibl M. Posterolateral fusion in acute traumatic thoracolumbar fractures: a comparison of demineralized bone matrix and autologous bone graft. The difference was statistically significant (p = 0.0217) between Groups 1 and 3, but not between Groups 2 and 3 (p = 0.1627). 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. 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, the complication profile of BMP in this patient population seems to differ from that in adults and is yet to be completely understood. Additionally, issues of sub-optimal bone quality in osteoporotic patients and donor site morbidity after graft harvest have compelled the orthopaedic community to look for other options. Michael Fehlings reports no disclosures or conflicts of interest. More better quality studies are required comparing these substitutes and extenders not just with autografts, but also with each other. Precise contouring and fit may affect ultimate fusion success or failure. Bone graft substitutes for spine fusion: A brief review. Literature on the use of allograft cellular bone matrix/Stem cell based products is currently mostly in the form of level IV studies. Recent findings: The characterization of BMPs in . The site is secure. 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. 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). Korovessis et al.82 compared coralline hydroxyapatite (Pro Osteon) (n=19; group A), iliac bone graft (n=18; group B) or both (n=20; Group C) in the setting of instrumented posterolateral and lumbosacral fusions for patients with degenerative lumbar spinal stenosis. Sassard WR, Eidman DK, Gray PM, et al. A minimum of 1-year follow-up in 144 patients. No reports were found describing the clinical use of B2A in cervical spine surgery. Differences in the porosities of ceramic bone extenders may account for these conflicting results in clinical studies. Deerfield, MeSH 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. 1Pennsylvania Hospital of the University of Pennsylvania Health System, Philadelphia, PA, 3Toronto Western Hospital, Toronto, Canada, 4Center for Spine & Orthopaedics, Denver, CO. Jarcho M. Calcium phosphate ceramics as hard tissue prosthetics. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. In single-level procedures, there was no significant difference in fusion rates (100% vs. 93.3%, p = 0.197) and graft collapse rates (0% vs. 3.4%, p = 0.365) between autograft and allograft, respectively. Three other level IV studies58, 85, 86 also supported the use of hydroxyapatite as an effective option in combination with other bone graft substitutes such as allograft and autograft. eCollection 2017 Feb 18. government site. Surgical treatment of spinal fractures consists of postural reduction and segmental arthrodesis, together with an eventual performance of spinal canal decompression. Higher physical function scores were observed in the DBM group at 2 year follow-up, although this also was not statistically significant. Posterior lumbar interbody fusion using rhBMP-2. 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. Definitive evidence of osteoinduction in humans: a preliminary report. No complications were reported in the study. 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. Godzik J, Ravindra VM, Ray WZ, Schmidt MH, Bisson EF, Dailey AT. More comparative studies are needed to evaluate the efficacy of bone graft substitutes overall. Bone graft substitutes for spinal fusion . 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. +: the material has this property. Invited submission from the Joint Section Meeting on Disorders of the Spine. Bone morphogenetic protein (RhBMP-2) as a substitute for iliac crest bone graft in multilevel adult spinal deformity surgery: minimum two-year evaluation of fusion. 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). Buttermann et al.143 (level II) also concluded that ACDF performed with rhBMP-2 combined with allograft (0.9 mg BMP per level) was as effective as iliac bone graft in terms of clinical outcomes and fusion rates in a prospective cohort study. Allograft works well as an osteoconductive scaffold with some degree of osteoinductive properties. Disclaimer, National Library of Medicine Interbody arthrodesis was performed using polyether-ether-ketone (PEEK) cages which were filled with 8 mg of rhBMP-2 in the study group and 2.5 mL of autologous bone in the control group. Epstein NE. There are several level I and level II studies describing rhBMP-2 usage in anterior lumbar fusion applications. Schuster JM, Avellino AM, Mann FA, et al. 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. Orthop Rev (Pavia). Peter Whang. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Bone graft substitutes replace bone harvested from the patient or from a donor. 1999-2022 Veritas Health, LLC. Burkus et al.114 conducted a prospective, randomized, multicenter study (level I) involving 131 patients to evaluate the safety and efficacy of rhBMP-2 as a replacement for autogenous ICBG in anterior lumbar spinal arthrodesis. Haid RW, Branch CL, Alexander JT, Burkus JK. Sayama C, Hadley C, Monaco GN, et al. Kleeman TJ, Ahn UM, Talbot-Kleeman A. Laparoscopic anterior lumbar interbody fusion with rhBMP-2: a prospective study of clinical and radiographic outcomes. There are now multiple commercially available bone graft substitute options available. The ceramic granules used in Amplex have been FDA cleared for bone graft applications in the skeletal system. Nonindustry sponsored studies evaluating the efficacy of CBMs are required. A prospective randomized trial. A single case series of 27 patients (level IV) by Mashoof et al.92 was identified, concluding that coralline hydroxyapatite was a safe, biocompatible, and effective means of augmenting autogenous bone graft in the treatment of idiopathic adolescent scoliosis with posterior spinal fusion.
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