The present paper deals with the design, the repeatability, and the comparison to literature data of a new measuring device called “Rotameter” to characterize the rotational knee laxity or the tibia-femoral rotation (TFR). The initial prototype P1 of the Rotameter is shortly introduced and then modified according to trials carried out on a prosthetic leg and on five healthy volunteers, leading therefore to an improved prototype P2. A comparison of results obtained from P1 and P2 with the same male subject shows the enhancements of P2. Intertester and intratester repeatability of this new device were shown and it was observed that rotational laxities of left and right knees are the same for a healthy subject. Moreover, a literature review showed that measurements with P2 presented lower TFR values than other noninvasive devices. The measured TFR versus torque characteristic was quite similar to other invasive devices, which are more difficult to use and harmful to the patient. Hence, our prototype P2 proved to be an easy-to-use and suitable device for quantifying rotational knee laxity. A forthcoming study will validate the Rotameter thanks to an approach based on computed tomography in order to evaluate its precision.

The purpose of this study is to validate a noninvasive rotational knee laxity measuring device called “Rotameter P2” with an approach based on Computed Tomography (CT). This CT-approach using X-rays is hence invasive and can be regarded as a precise reference method that may also be applied to similar devices. An error due to imperfect femur fixation was observed but can be neglected for small torques. The most significant estimation error is due to the unavoidable soft tissues rotation and hence flexibility in the measurement chain. The error increases with the applied torque. The assessment showed that the rotational knee angle measured with the Rotameter is still overestimated because of thigh and femur displacement, soft tissues deformation, and measurement artefacts adding up to a maximum of 285% error at +15 Nm for the Internal Rotation of female volunteers. This may be questioned if such noninvasive devices for measuring the Tibia-Femoral Rotation (TFR) can help diagnosing knee pathologies and investigate ligament reconstructive surgery.