Outcome Assessment for ACL Tissue Engineering
Outcome assessment measures, directly or indirectly, how well a medical treatment functions. For clinical treatments this is measured by measuring safety (i.e., the rate of complications) and effectiveness (i.e., resolution of pain or improvement in function). For basic science, outcome assessment often means objectively quantifying cellular behavior and characteristics and other laboratory measurements. When developing tissue engineering treatments for improving outcomes following ACL injury, evaluation of the tissue-engineered structure is necessary to optimize the treatment, too. These evaluations prove that the method will be safe and efficacious and demonstrate that the alternative treatment is better than the gold standard, in our case, ACL reconstruction with an autograft. When translating any new technology from benchtop (lab) to the bedside (clinic), in vitro (petri dish) studies and preclinical models are first required to validate the concept and to prove that it is likely to be efficacious, prior to initiating a clinical trial in humans. This chapter briefly highlights some of the outcome measures that are important at all three levels: in vitro, preclinical, and clinical studies.
KeywordsFailure Load Preclinical Model Gait Analysis Pivot Shift Knee Laxity
Research reported in this chapter was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Numbers RO1-AR047910, RO1-AR054099 and RO1-AR056834. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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