Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Pre-operative pocket depths, attachment levels, and trans-operative bone measurements were similar for the 2 groups. In these patients TCP was used to fill a defect after excochleation of an aneurysmal bone cyst or fibrous dysplasia. Safety was determined by any implant-related AE. Nacre can be used directly as a bulk implant or as part of a composite material when combined with polymers or other ceramics. The level of expression of bone sialoprotein was higher in MSC from the IC than the VB. Recombinant human bone morphogenetic protein-2 for spinal surgery and treatment of open tibial fractures. In a prospective, single-arm, proof-of-principle study, these researchers examined the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bio-inductive collagen scaffold patch. Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: A systematic review. Dis Colon Rectum. This was the first publication showing the efficacy of V-CBA cellular bone allograft via histological results in human subjects; these preliminary findings need to be validated by well-designed studies. In general, cSVF and tSVF intraoperative isolation procedures had similar cell yield, cell viability and SVF composition compared to a non-intraoperative (i.e., culture laboratory-based collagenase protocol) control group within the same studies. A technology assessment prepared by the ECRI Institute (Schoelles et al, 2005) for the Agency for Healthcare Research and Quality, commenting on this study, stated that "[w]ithout this information, interpretation of the results is difficult". (The study by Mobb et al 2014 is discussed in CPB 0411 -- The authors stated that limitations of this study were the lack of direct control and the potential for respondent bias. Aetna considers the Pro Osteon Porous Hydroxyapatite Bone Graft Substitute experimental and investigational for repair of metaphyseal fracture defects or repair of long bone cyst and tumor defects, because it has not been shown to be more effective than autograft or cadaveric allograft for these indications. Definitive fixation with bone cements during difficult ossicular chain reconstruction may ensure a more enduring successful outcome. Decision memo for autologous blood derived products for chronic non-healing wounds (CAG-00190R2). Luyten FP.  05/21/2021 However, assessment of fusion and neurological success was performed by independent blinded adjudicators, and assessment of functional and quality of life outcomes was self-reported by blinded subjects. A total of 17 cleft sites treated with ISO were evaluated at 6 months post-operative using low-dose spiral computed tomography with 1-mm cuts limited to the maxilla. However, no clinical studies have reported its effect in diabetic patients who commonly experience compromised tissue perfusion, regardless of the status of intravascular blood flow. Lerner T, Bullmann V, Schulte TL, et al. Furthermore, patients' commitment/compliance to rehabilitation is important to attain a good surgical outcome. In all cases, the strategy was debridement, with removal of any implants, with excision back to bleeding bone. Surgisis AFP Anal Fistula Plug. Technology Assessment. Living cryopreserved bone allograft as an adjunct for hindfoot arthrodesis. Aspirates of vertebral marrow demonstrated comparable or greater concentrations of progenitor cells compared with matched controls from the iliac crest. Buser Z, Brodke DS, Youssef JA, et al. Patients with implanted HA prostheses composed a matched control group. Bone Joint Surg Am. However, despite the appeal of this approach, there is a paucity of data supporting the efficacy of using stem cells in a clinical setting for spinal surgery. Dai and colleagues (2020) noted that partial thickness rotator cuff tears (PTRCT) have low healing potential and tend to progress over time if not addressed surgically. The reported healing rate was 30 of 35 (85 %) in an average of 3.5 months, but healing rates per bone type were not reported. Studies, both in-vitro and in-vivo, have demonstrated nacre's biocompatibility, biodegradability, and osteogenic potential, which are superior to pure inorganic minerals such as hydroxyapatite or non-degradable metals. No serious AEs related to the implant were reported. The patients were followed up till the end of 2010. An H, Yeung C, Field J, Roh J. Fourth, in this study, these investigators examined men only; thus these observations may not be generalized to women or other populations. There are no studies evaluating the DeNovo ET tissue graft in the published medical literature. Acta Orthop Belg. Mean IKDC score, Tegner-Lysholm outcomes, and Lysholm-Gillquist scale improved from 45, 2.5, and 50, respectively, at surgery to 75, 4, and 70, respectively, at 24-month follow-up. Prospective analysis of a new bone graft in lumbar interbody fusion: Results of a 2- year prospective clinical and radiological study. Consequently, CMS issued a non-coverage determination for acute surgical wounds when the autologous PRP is applied directly to the closed incision and for dehiscent wounds. Clinical Validation of Allogeneic Morphogenetic Protein: Donor Intervariability, Terminal Irradiation and Age of Product is not Clinically Relevant. The 4 patients (mean age of 23 years [range of 18 to 32]) were all male with an estimated body surface area affected with RDEB of 4 % to 30 %. This new technique is a valuable alternative to conventional ossiculoplasty and presents the practical advantage of being easier and faster. would increase the rate of successful ankle fusion in complex patients (patients with co-morbidities associated with poor surgical healing) compared with a control group of patients undergoing ankle fusion who did not receive rhBMP-2; would reduce total time wearing a frame when compared with the control group; would result in a difference in the percentage of bone bridging between the group treated with rhBMP-2 and the control group, as determined by CT scans 3 months after surgery; and. K062353. Fistula tracts were occluded by fibrin glue versus closure of the primary opening using a Surgisis anal fistula plug. PubMed, Ovid Medline, Embase, Web of Science, and the Cochrane Library were searched for articles about use of SVF or ASC for disease therapy published between 2012 and 2017; 1 meta-analysis, 2 randomized controlled trials (RCTs), and 16 case series were included, representing 844 human patients; 69 studies were performed in pre-clinical models of disease. The authors stated that this study had several drawbacks. Of 20 patients, 19 were completely asymptomatic following surgical intervention, and of the 3 with failed repairs, only 1 patient required revision surgery for persistent symptoms. These researchers evaluated the efficacy of calcium sulfate absorbable antibiotic beads (CSAAB) in the prevention of SSIs for complex wound closures. Moon KC, Chung HY, Han SK, et al. The proportion of patients achieving fistula closure varied widely between studies for non-Crohn's, ranging from 0.2 (95 % confidence interval [CI] 0.04 to 0.48) to 0.86 (95 % CI: 0.64 to 0.97). It might seem impossible to you that all custom-written essays, research papers, speeches, book reviews, and other custom task completed by our writers are both of high quality and cheap. Is platelet-rich plasma the perfect enhancement factor? They evaluated cases where amnion tissue was used with a minimum follow-up of 120 days between 2011 and 2012. Guidelines from the Work Loss Data Institute (2008) on work-related disorders of the elbow state that platelet-rich plasma and autologous blood donation are under study and are not specifically recommended. There were no significant differences in the reported clinical outcomes across all classes of bone substitutes. The most frequent side effects encountered in soft tissue repair include infection, adhesions, sterile effusion, instability, increased stiffness post-operatively, and general risks associated with surgery and anesthesia such as neurological, cardiac, and respiratory deficit. For the patients with lumbar spinal degenerative disease, data from 19 comparative studies were included: 3 RCTs, 12 prospective, and 4 retrospective studies. The device is intended to act as a resorbable scaffold that initially has sufficient strength to assist with a soft tissue repair, but then resorbs and is replaced by the patient's own tissue. Complete an audit. Mussano F, Ciccone G, Ceccarelli M, et al. Prepared by the Blue Cross and Blue Shield Association Evidence-based Practice Center (EPC) for the Agency for Healthcare Research and Quality (AHRQ) under Contact No. The proportion achieving closure in patients with Crohn's disease was similar (0.55, 95 % CI: 0.39 to 0.70). Synthetic bone graft versus autograft or allograft for spinal fusion: A systematic review. Technote 37. Strut allograft healing to the femur with recombinant human osteogenic protein-1. OsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). Am J Sports Med. Use of calcium-based demineralized bone matrix/allograft for nonunions and posttraumatic reconstruction of the appendicular skeleton: Preliminary results and complications. A comparison between the lower heterogeneity studies and the long-term observational outcomes showed a slight tendency to enhance bone formation. 2019;12(9). Thalgott JS, Klezl Z, Timlin M, Giuffre JM. Their treatment is tailored to the zone of the hand that is affected since varying biomechanical forces are applied to the tendon at each zone. The composite end-point of overall success (fusion, NDI improvement greater than 15, neurological success, and absence of re-operations) was greater in i-Factor subjects compared to autograft subjects (69.83 % and 56.35 %, respectively, p = 0.0302); 12 (7.45 %) i-Factor subjects and 16 (10.53 %) autograft subjects underwent re-operation (p = 0.3411). 2019;39:22-27. Language services can be provided by calling the number on your member ID card. With the numbers available, there were no significant differences relative to vertebral body level, the side aspirated, the depth of aspiration, or gender. Unfortunately, the current literature lacks an accepted standard number of MSCs needed to promote bony healing in the setting of arthrodesis, adding another layer of complexity to the issue. Spine. list-style-type: upper-alpha; According to the PRISMA statement for reporting systematic reviews, different types of clinical studies concerning treatment of osteomyelitis with bone graft substitutes were included. The iliac crest has long been the preferred source of autograft material, but graft harvest is associated with frequent complications and pain. Bozic KJ, Glazer PA, Zurakowski D, et al. NIHR Horizon Scanning Centre. Anterior lumbar interbody fusion with processed sea coral (coralline hydroxyapatite) as part of a circumferential fusion. Calcium phosphate is injected by use of a series of syringes until the appropriate fill is obtained. Ceramics have been present in the spine fusion arena for several decades; however, their use has been limited. The zones of inhibition for the Cerament Bone Void Filler antibiotic discs plated against Staphylococcus aureus obtained were 33 % to 222 % greater than the minimum zones of inhibition breakpoints for bacteria susceptibility as defined by the standard set by the Clinical and Laboratory Standards Institute (CLSI). 2014;39(22):E1331-E1337. Arming surgeons with accurate bone stiffness information may reduce surgical complications including periprosthetic fractures. Autogenic MSCs in animal models can arrest intervertebral disc degeneration or even partially regenerate it, and the effect is suggested to be dependent on the severity of degeneration. Treatment group effects were evaluated using general linear models on the basis of intention-to-treat. The first 40 patients did not receive rhBMP-2, whereas the subsequent 42 patients received intraoperative rhBMP-2. The authors stated that this study had several drawbacks. There are several methodological limitations and, consequently, future research should focus on strong and well-designed RCTs that evaluate the safety and effectiveness of PRP. The main drawbacks of this study were its retrospective design, the number of patients in each group vary in sample size, and the reporting clinical outcomes (relief of pain via VAS, restoration of function via ODI, patient satisfaction, etc.) The material consists of hydroxyapatite and calcium sulfate hemihydrate. Mindea SA, Shih P, Song JK. Tissue-engineered rotator cuff tendon using porcine small intestine submucosa. These complications included swelling of the neck and throat tissue that caused difficulty breathing, swallowing or speaking. Therefore, use of Vivigen, OsteoAMP, OsteoAMP Select, and Intergro are considered not medically necessary. 2010;(5):CD006319. Clinical application of antimicrobial bone graft substitute in osteomyelitis treatment: A systematic review of different bone graft substitutes available in clinical treatment of osteomyelitis. Toronto, ON: Ontario Ministry of Health and Long-Term Care; April 2005. Last Review Recently, the prevalence of reported adverse events (AEs) and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Regeneration of guided bone is an established procedure used in implant dentistry to increase the quality and quantity of the host bone in sites of localized alveolar defects. Li Z, Khun NW, Tang XZ, et al. The authors stated that the superiority of the experimental group could not be attributed solely to the surgical intervention and was likely a result of the BPBM/GTR/ PRP application. Staining for STRO-1 was seen by immunohistochemistry but not flow cytometry. The augmentation with bone graft substitute is often needed to support the fixation to maintain reduction. Multiple major medical reference databases were searched for studies that evaluated spinal fusion using synthetic bone graft substitutes (either alone or with an autograft or allograft) compared with autograft and allograft; RCTs and cohort studies with more than 10 patients were included. In a randomized controlled study (n = 24), Huang et al (2005) examined the effects of PRP in combination with coronally advanced flap (CAF) for the treatment of gingival recession. These were further grouped depending on their application in lumbar and cervical spine surgeries, deformity correction or other miscellaneous procedures, namely, trauma, infection or tumors; wherever data were forthcoming. The authors concluded that high fusion rate resulted in this report demonstrated the benefits of using an array of growth factors in cervical spine surgery and supported allogeneic morphogenetic protein as a possible alternative option to rhBMP-2. No significant difference was observed between the radio-stereometric and radiographic results of fusion with the OP-1 Implant and fusion with autograft bone. Wounds with recombinant type VII collagen graft sites displayed 75 % or greater healing at 3 months (21 intact graft sites of 24 wound sites; 87 %), 6 months (16/24; 67 %), and 12 months (12/24; 50 %) compared with baseline wound sites. Aetna considers the use of platelet-rich plasma, alone or in conjunction with bone grafting materials, experimental and investigational for augmentation procedures (e.g., for dental implants and for the floor of the maxillary sinus) or indications (e.g., soft tissue injuries) other than thrombocytopenia because its effectiveness has not been established. Each patient received CSAAB prophylaxis during operations performed by the principle investigator. Complications include periosteal hypertrophy observed in 2 patients. These investigators also noted that a retrospective case-control study, which contained a mixed group of long-bone infections, found favor in the use of Osteoset-T; however, prospective data on Osteoset-T were limited, with published work concentrating on post-traumatic osteomyelitis in long bones but without comparison with controls. The authors stated that there had been no previous comparative studies concerning the use of TCP versus allograft in the literature. 2001;29(2):175-184. Marx RE. At the final follow-up visit, no radiologic signs of pseudoarthrosis were found in either group with a minimum follow-up of 4 years. They noted that the delivery of MSCs, derived from adult bone marrow, to regions requiring bone formation is also compelling, and it has been shown to be successful in inducing osteogenesis in many pre-clinical animal studies. In-vivo investigation is constrained to the use of small immune- deficient animals, because cellular allografts have retained human cells that would be rejected in immune-competent models. 2007;63(6):1324-1328. 2001;67(2):110-115. Sanchez et al (2003) stated that “there is clearly a lack of scientific evidence to support the use of PRP in combination with bone grafts during augmentation procedures. Moreover, these researchers stated that given these results with the CAIS procedure, testing in human patients is the next logical step; and a phase-I human clinical trial has proceeded from this work. Similar to mammalian bone, the highly organized microstructure of nacre endows the composite with superior mechanical properties while the organic phase contributes to significant bioactivity. Second, there were also drawbacks with other technologies. Revision surgery demonstrated solid bone formation directly above the pseudarthrosis with no histological evidence of b-TCP in the biopsy taken. Bone. Patients underwent radiographs (x-ray and/or CT) at standard post-operative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. The time required for OsteoAMP to achieve fusion was approximately 40 % less than rhBMP-2 with approximately 70 % fewer complications. SVF and ASC have been used clinically to improve tendon healing, yet their mechanism of action is not fully elucidated. These results provided a proof-of-principle that an intra-operative engineering of autologous cell-based vasculogenic bone substitutes is feasible, but highlighted that -- in the absence of in-vitro commitment -- additional cues (e.g., low dose of osteogenic factors or orthotopic environmental conditions) are likely needed to support complete osteoblastic cell differentiation and bone tissue generation. Buchberg et al (2010) compared the Cook Surgisis AFP plug and the newer Gore Bio-A plug in the management of complex anal fistulas. 2006;31(10):1067-1074. These researchers carried out an analysis of radiographic results comparing fusion outcomes for 285 consecutive cervical and lumbar spinal fusion patients utilizing OsteoAMP bone grafts from 114 donors of varying ages. Connective tissue autografts are commonly used as inter-positional grafts between the septal flaps. According to the manufacturer, DeNovo NT was developed as a consequence of the need for expanded treatment options for the treatment of cartilage lesions. There was MRI evidence of new tissue fill-in within the original baseline tear in 100 % of the intermediate-grade tears and 95 % of the high-grade tears. A total of 321 patients from 3 centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. Staphylococcus aureus was the most common microorganism isolated. Bone morphogenetic proteins and spinal surgery for degenerative disc disease. Niazi et al (2019) stated that diabetic foot ulcers are associated with a high morbidity and are common cause of non-traumatic lower limb amputations. HA as the sole reconstructive material for incus erosion. The purpose of this study was to evaluate the differences in proliferation, differentiation, and extracellular matrix (ECM) formation abilities between bone marrow stem cells (BMSCs) and ACL-derived stem cells (LSCs) from the same donors when cultured with different growth factors, including basic fibroblast growth factor (bFGF), epidermal growth factor, and transforming growth factor-beta 1 (TGF-beta1). These researchers examined functional and radiographic outcomes following surgical implantation of a collagen-based bio-inductive implant for the treatment of PTRCT. RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: A randomized, controlled trial in patients over sixty years of age.
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