Abstract
The trend toward evidence-based decision-making in orthopedics requires the analysis of large sets of data in real time that can direct clinical decision-making. We have developed an automated web-based electronic data capture (EDC) software system designed to simplify and make more time and cost efficient orthopedic data collection and analysis. The purpose of this study is to validate the radiographic alignment tool of the EDC software system. The goal was to establish the feasibility of using this web-based EDC tool in clinical practice.
Twenty-eight consecutive unilateral TKAs were performed on 28 patients. Coronal mechanical axis and sagittal tibial and femoral axis radiographic measurements were obtained preoperatively and 1 month postoperatively. The radiographs were uploaded to a web-based EDC knee surgery data analysis program that includes a radiographic measurement tool. Two blinded observers analyzed the radiographs; one using a conventional manual measurement tool and the other a web based measurement tool. A paired t-test was used to evaluate measurement variation between observers.
There was no statistically significant difference in pre-operative mechanical axis (.18°, p> .05), postoperative mechanical axis (.25°, p> .05), postoperative femoral component axis (.68°, p> .05), and postoperative tibial component axis (1.07°, p> .05) measurements performed using the manual tool and the web-based software systems.
The results of this study validate the ability of the web-based software system to collect and process radiographic measurements. An automated web-based EDC software system allows for the full integration of patient demographic, radiographic, and peri-operative clinical variables in a fully searchable, instantaneously updatable and easily analyzed database. It is anticipated that this unique approach will allow surgeons to gather a wealth of searchable and quantifiable data that can quickly, accurately, economically, and efficiently shape clinical decisions.
Correspondence should be addressed to Diane Przepiorski at ISTA, PO Box 6564, Auburn, CA 95604, USA. Phone: +1 916-454-9884; Fax: +1 916-454-9882; E-mail: ista@pacbell.net