An assessment by the BlueCross BlueShield Association Technology Evaluation Center (BCBSA, 2014) stated: "The choice of bone material for interbody fusion in [anterior cervical discectomy and fusion] ACDF has important clinical implications. Allograft bone has several drawbacks, including a minute (albeit unproven) risk of infectious disease transmission; possible immunological reaction to the allograft; and possible limited commercial availability of appropriate graft material. In contrast, the use of autograft bone in ACDF has potentially substantial morbidities at the harvest site, generally the iliac crest. These include moderate-to-severe, sometimes prolonged pain; deep infection; adjacent nerve and artery damage; and increased risk of stress fracture. Although there may be slight differences between autograft and allograft sources in the postoperative rate of union, clinical studies have demonstrated similar rates of postoperative fusion (90%–100%) and satisfactory outcomes for single-level, anterior-plated ACDF using either bone source. Thus, the choice of graft material involves a trade-off between the risks specific to autograft harvest versus those specific to use of allograft material."
Information from the National Library of Medicine
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Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion:
Cystic fibrosis is a rare disease that affects about 30,000 people in the United is indicated for patients aged 2 and older who have one mutation in the CFTR gene that is responsive to drug treatment based on clinical and/or in vitro (laboratory) data. The expanded indication will affect another 3 percent of the cystic fibrosis population, impacting approximately 900 patients. Kalydeco serves as an example of how successful patient-focused drug development can provide greater understanding about a disease. For example, the Cystic Fibrosis Foundation maintains a 28,000-patient registry, including genetic data, which it makes available for research.