Musculoskeletal allograft risks and recalls in the United States.
ABSTRACT There have been several improvements to the US tissue banking industry over the past decade. Tissue banks had limited active government regulation until 1993, at which time the US Food and Drug Administration began regulatory oversight because of reports of disease transmission from allograft tissues. Reports in recent years of disease transmission associated with the use of allografts have further raised concerns about the safety of such implants. A retrospective review of allograft recall data was performed to analyze allograft recall by tissue type, reason, and year during the period from January 1994 to June 30, 2007. During the study period, more than 96.5% of all allograft tissues recalled were musculoskeletal. The reasons underlying recent musculoskeletal tissue recalls include insufficient or improper donor evaluation, contamination, recipient infection, and positive serologic tests. Infectious disease transmission following allograft implantation may occur if potential donors are not adequately evaluated or screened serologically during the prerecovery phase and if the implant is not sterilized before implantation.
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ABSTRACT: Several surgical options for managing high-grade spondylolisthesis have been described in the literature and range from posterior-only in situ fusion to circumferential fusion with complete reduction of the dislocation. The level of evidence supporting any one technique is weak, and to date there is no Level I or II evidence supporting any current surgical treatment option. Techniques have evolved as implant technology has advanced and surgeons have gained experience with deformity correction. Still, the paucity of cases at any one institution limits the ability to perform clinical studies in a prospective and randomized fashion. To the authors' knowledge, the use of the AxiaLif bolt in a modified Bohlman technique has not been described. In the setting of a case of symptomatic high-grade spondylolisthesis refractory to nonoperative management, the authors describe a modified Bohlman technique in which they used the AxiaLif bolt rather than the fibula graft that was originally described. They then supplemented this with pedicle screw instrumentation and an iliac crest autograft. At the 2-year follow-up exam, the patient exhibited relief of his preoperative back and leg pain and he had returned to all activities. The latest radiographs demonstrated successful fusion. A single-stage, posterior instrumented fusion in which the AxiaLif bolt is used in lieu of fibula autograft or allograft in a modified Bohlman technique is technically less demanding, does not have the morbidity associated with harvesting a fibula autograft, and carries no risk of disease transmission associated with the use of allograft.Journal of Neurosurgery Spine 11/2014; · 2.36 Impact Factor
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ABSTRACT: Osteochondral lesions of the talus are being recognized as an increasingly common injury. They are most commonly located postero-medially or antero-laterally, while centrally located lesions are uncommon. Large osteochondral lesions have significant biomechanical consequences and often require resurfacing with osteochondral autograft transfer, mosaicplasty, autologous chondrocyte implantation (or similar methods) or osteochondral allograft transplantation. Allograft procedures have become popular due to inherent advantages over other resurfacing techniques. Cartilage viability is one of the most important factors for successful clinical outcomes after transplantation of osteochondral allografts and is related to storage length and intra-operative factors. While there is abundant literature about osteochondral allograft transplantation in the knee, there are few papers about this procedure in the talus. Failure of non-operative management, initial debridement, curettage or microfractures are an indication for resurfacing. Patients should have a functional ankle motion, closed growth plates, absence of cartilage lesions on the tibial side. This paper reviews the published literature about osteochondral allograft transplantation of the talus focusing on indications, pre-operative planning, surgical approaches, postoperative management, results and complications of this procedure.The Iowa orthopaedic journal 01/2014; 34:30-7.
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ABSTRACT: Bone substitutes are being increasingly used in surgery as over two millions bone grafting procedures are performed worldwide per year. Autografts still represent the gold standard for bone substitution, though the morbidity and the inherent limited availability are the main limitations. Allografts, i.e. banked bone, are osteoconductive and weakly osteoinductive, though there are still concerns about the residual infective risks, costs and donor availability issues. As an alternative, xenograft substitutes are cheap, but their use provided contrasting results, so far. Ceramic-based synthetic bone substitutes are alternatively based on hydroxyapatite (HA) and tricalcium phosphates, and are widely used in the clinical practice. Indeed, despite being completely resorbable and weaker than cortical bone, they have exhaustively proved to be effective. Biomimetic HAs are the evolution of traditional HA and contains ions (carbonates, Si, Sr, Fl, Mg) that mimic natural HA (biomimetic HA). Injectable cements represent another evolution, enabling mininvasive techniques. Bone morphogenetic proteins (namely BMP2 and 7) are the only bone inducing growth factors approved for human use in spine surgery and for the treatment of tibial nonunion. Demineralized bone matrix and platelet rich plasma did not prove to be effective and their use as bone substitutes remains controversial. Experimental cell-based approaches are considered the best suitable emerging strategies in several regenerative medicine application, including bone regeneration. In some cases, cells have been used as bioactive vehicles delivering osteoinductive genes locally to achieve bone regeneration. In particular, mesenchymal stem cells have been widely exploited for this purpose, being multipotent cells capable of efficient osteogenic potential. Here we intend to review and update the alternative available techniques used for bone fusion, along with some hints on the advancements achieved through the experimental research in this field.Journal of Materials Science Materials in Medicine 05/2014; · 2.14 Impact Factor