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A862. PRE-CLINICAL EVALUATION OF TOTAL KNEE DESIGNS FOR RESTORING NORMAL KNEE MECHANICS



Abstract

The objective was to develop a simple, rapid, and low-cost method for evaluating proposed new Total Knee (TKA) designs, and then to use the method to evaluate three different TKA models with different kinematic characteristics. In a previous study, we reported on the use of an Up-and-Down Crouching Machine, where the neutral path of motion for knee specimens were measured, and then TKR models were implanted and the tests repeated. These experiments showed that standard CR and PS designs behaved more like an ACL deficient knee, whereas Guided Motion knees produced motion similar to that of the intact specimens. However the method was time consuming, technically demanding, and expensive, and hence is suitable for designs which had already passed through a screening method. The latter was the subject of this present study, called the Desktop TKR Test Machine.

The principle of the testing protocol on the machine, called Holistic Testing, was that a spectrum of compressive, shear and torque forces were applied to a knee, to represent a complete spectrum of daily and sporting activities. The resulting femoraltibial positions were measured, both the Neutral Path of Motion and the Laxity about the neutral path. The motions were displayed as both the motion of the transverse femoral axis on the tibial surface, and by the centers of the lateral and medial contact patches.

Eight knee specimens were tested first, to act as a reference target for evaluating TKR models. Knee models were designed in the computer and made in a hard low-friction plastic using SLA and stereolithography.

A typical Posterior-Stabilized (PS) TKA did not display the normal external femoral rotation with flexion, and also showed abnormal anterior sliding on the medial side prior to cam-post engagement. Guided Motion designs included a Medial Pivot type, and a Medial Pivot with a cam-post. Both of these had a dished medial side and a shallow lateral side, to more accurately reproduce anatomic motion characteristics. The guidedmotion design with the cam-post produced a neutral path and laxity more similar to that of normal.

It was concluded that the test method satisfied the objective in terms of being a useful test method for rapid evaluation of new proposed TKR designs. The method was able to identify designs which showed motion and stability characteristics closer to the normal anatomic knee.

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