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Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 473 - 473
1 Nov 2011
Stulberg S Yaffe M Villacis D
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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.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 449 - 449
1 Nov 2011
Puri L Moen T Villacis D
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When compared with traditional techniques, computer-assisted total knee arthroplasty (TKA) has been shown to allow more accurate coronal alignment of the implants with fewer “outliers.” Most navigation systems in computer-assisted TKA utilize rigidly-fixed trackers placed on both the femur and tibia, a computer workstation, and navigation software to determine the mechanical axis of the extremity intraoperatively, in real time. The purpose of this study was to report the initial experience of a single surgeon with a novel navigation system. This system utilizes a “pinless” technique using trackers that are mounted at the articular surface of the knee instead of being fixed to the femur and tibia.

Sixty-Six consecutive TKAs were performed using a novel “pinless” navigation system by a single surgeon. At 4 weeks post-operatively, coronal alignment was assessed with long-standing AP radiographs. The alignment measurements were then compared to historical controls.

The average alignment in the coronal plane was 1.73° +/−1.50° deviation from neutral alignment. Variance was 2.26°. The c onfidence interval constructed with an alpha value of.05 was (1.50°, 2.40°). Five knees had a coronal alignment greater than 3° from neutral. Of these five, three had an ipsilateral total hip replacement, and 2 were morbidly obese. There were no pin site infections nor pin site fractures. There was 1 late hematogenous infection.

This study reports an initial single-surgeon experience of a novel “pinless” navigation technique for TKA. The technique in this study is a novel and safe method to reconstruct a neutral mechanical axis, as it avoids the morbidity of the application of navigation tracking pins and therefore enhances patient safety.