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: PURPOSE: Although a large number of anterior cruciate ligament (ACL) reconstructions are performed annually, there remains a considerable amount of controversy over whether an autograft or an allograft should be used. The aim of this meta-analysis was to compare the clinical outcomes of allograft and autograft in primary ACL reconstruction. METHODS: The authors systematically searched electronic databases to identify prospective studies which compared allografts with autografts for primary ACL reconstruction. The results of the eligible studies were analysed in terms of instrumented laxity measurements, Lachman test, Pivot Shift test, objective International Knee Documentation Committee (IKDC) Scores, Lysholm Scores, Tegner Scores, and clinical failures. Study quality was assessed and relevant data were extracted independently by two reviewers. A random effect model was used to pool the data. Statistical heterogeneity between trials was evaluated by the chi-square and I-square tests. RESULTS: Nine studies, with 410 patients in the autograft and 408 patients in the allograft group, met the inclusion criteria. Five studies compared bone-patellar tendon-bone (BPTB) grafts, and four compared soft-tissue grafts. Four studies were randomized controlled trials, and five were prospective cohort studies. The results of the meta-analysis showed that there were no significant differences between allograft and autograft on all the outcomes in terms of instrumented laxity measurements (P = 0.59), Lachman test (P = 0.41), Pivot Shift test (P = 0.88), objective IKDC Scores (P = 0.87), Lysholm Scores (P = 0.79), Tegner Scores (P = 0.06), and clinical failures (P = 0.68). These findings were still robust during the sensitivity analysis. However, a subgroup analysis of Tegner scores by involving only BPTB grafts showed a statistical difference in favour of autografts (P = 0.005). CONCLUSIONS: There was insufficient evidence to identify which of the two types of grafts was significantly better for ACL reconstruction, though the subgroup analysis indicated that reconstruction with BPTB autograft might allow patients to return to higher levels of activity in comparison with BPTB allograft. More high-quality randomized controlled trials with specified age and activity level are highly required before drawing a reliable conclusion.International Orthopaedics 12/2012; · 2.32 Impact Factor
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ABSTRACT: The aim of this study was to analyze factors contributing to bacteriological contamination of bone and tendon allograft. Between 2008 and 2011, 2,778 bone and tendon allografts obtained from 196 organ and tissue donors or tissue donors only were retrospectively analysed. Several variables were taken into account: donor type (organ and tissue donors vs. tissue donor), cause of death, time interval between death and tissue procurement, duration of the procurement procedure, type of allografts, number of team members, number of trainees members, associated surgical procedures, positivity to haemoculture, type of procurement. The overall incidence of graft contamination was 23 %. The cause of death, the procurement time, the duration of procurement, the associated surgical procedures were not associated with increased risk of contamination. Significant effect on contamination incidence was observed for the number of staff members performing the procurement. In addition, our study substantiated significantly higher contamination rate among bone allografts than from tendon grafts. According to these observations, in order to minimize the contamination rate of procured musculoskeletal allografts, we recommend appropriate donor selection, use of standard sterile techniques, immediate packaging of each allograft to reduce graft exposure. Allograft procurement should be performed by a small surgical team.Cell and Tissue Banking 05/2014; · 1.17 Impact Factor
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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