Fig. 39.1
Positioning of the sensor during PS analysis
The device can be also used during the intraoperative dynamic laxity evaluation [21]. For this specific condition, the sensor needs to be enclosed in a specifically developed sterilizable box which will be then skin fixed to the patient. No other modifications are required (Fig. 39.2).
Fig. 39.2
Intraoperative setup: trackers of navigation system and noninvasive device for dynamic laxity evaluation
In order to validate the proposed device, different clinical studies have been carried out [21–24]. Compared to these works, it is worth noting that the easiness of using the purposed device does not involve any alteration to the surgical procedure or operative setup when the device is intraoperatively used. It has been specifically designed with material resistant to sterilization which makes cleaning quick, easy, and complete. The device shows an ergonomics for simplicity of use and easy placement by the surgical team. Even the software has been designed in order to be easily used even by nontechnical personnel, such as the surgeon. The software interface (Fig. 39.3) is simple and intuitive, and this ease of use is demonstrated by the short time needed for learning, which has been proven by using the device even by nonspecifically trained surgeons [25]. The main limitation of the purposed method consisted in the execution way of the maneuver which is manually performed without load control. This limitation is partially compensated by the introduction of a standardized test [15]. Anyway, the high level of intra- and inter-tester repeatability strengthens the validity of the purposed method. Even the different interpretations on how to apply and evaluate the PS test among the different surgeons represent a criticality in the definition of an objective evaluation of the test. We also defined a trial study during the Panther Global Summit (Pittsburgh, August 2011), where 12 expert surgeons evaluated the effect of the standardization in the PS maneuver [26]. In such study, the KiRA device was used to quantify the ligament laxity. After watching an instructional video, explaining the PS test, the 12 acceleration curves look similar, whereas during the surgeons’ preferred technique, they did not [15].
Fig. 39.3
KiRA software interface for pivot shift test quantification (Orthokey LLC, DE, USA). On the left part of the screen, there are the acceleration values acquired both on the left (D) and right (S) knee joint as well as the difference between them (T). On the right part, there is whole acquired signal for the left knee
39.3.1 Discussion
Instrumental dynamic laxity evaluation during pivot shift test, using acceleration sensors, appears to be promising at this time. The development of such technology has made pivot shift more objective. The main problem in evaluating PS test was reported to lay on the complexity of the maneuver which makes it a surgeon-subjective laxity examination [27–31]. The test was described as depending also on the patient ability to relax their muscles during the examination [32]. Given that, there is still a lack of possibility for accurate pivot shift test quantification above all in office practice. The current solution using acceleration sensor made significant contributions to the scientific knowledge on the clinical PS test, introducing a possibility of quantifying the maneuver in a noninvasive fashion. ACL reconstruction is currently the seventh most common surgical procedure in the USA [33], and during the period 2000–2010, the research data in terms of ACL research have more than doubled [34]. A timely and precise diagnosis is certainly the first step to allow a successful recovery of the incident. Even if a careful history, detailed preoperative MRI, and physical examination will always remain fundamental for a complete evaluation, the possibility to perform an instrumented objective and quantitative evaluation of joint laxity represents a need for the orthopedic surgeon dealing with this issue. Using the current device, no anatomical registration phase is required before the data acquisition. The analysis is based on the definition of few simple parameters that are automatically and real time detected by the custom-made software. Moreover, the noninvasiveness of the presented sensor allows evaluating the side-to-side difference in each patient. As the ligament laxity is highly characteristic of each single subject, the comparison between the two joint results is more suitable for an objective diagnosis, deleting the baseline joint laxity [35]. Furthermore, since the PS was proved to be variable and difficult to execute [36–38], even considering the same surgeon and the same patient, the intra-tester repeatability in a controlled setup using the acceleration signal to quantify PS test has been evaluated. The obtained reliability was comparable to the results that the literature reports for static laxity test [38]. As previously reported, part of the validation of the purposed method was performed by the comparison with the navigation system outcome, which is considered the gold standard for intraoperative laxity evaluation. Indeed, for the knee laxity evaluation, navigation systems represent the gold standard. Unfortunately, even if the CAS system allows for a reliable and quantitative evaluation, being highly invasive, a navigation system becomes applicable only during the surgery and excludes the possibility to evaluate the contralateral limb and, clearly, its use in ambulatory practice. In any event, the reproducibility and accuracy of the CAS system for ACL laxity evaluation support its use as the reference gold standard against which other devices should be tested. Further studies will be dedicated to optimize and simplify the developed device making it a universal tool that can be used in the clinical practice to assess clinical outcome after ACL injury and surgery, as well, thus allowing a complete analysis of knee joint laxity, providing information not only on the acceleration reached during the PS test but also quantitative knowledge about translations and rotations. In conclusion, the presented device could assist orthopedic surgeons in the assessment of the potential ACL injury. Quantification of dynamic laxity, following the current method, could help the surgeon in determination of surgical strategies specific for each patient since it is independent from the examiner. It would represent a major breakthrough in the field being the first device with such capability. Moreover, the noninvasiveness of the device guarantees its use during the whole postoperative course and in case of sportive patients offers a concrete possibility to monitor when the dynamic laxity decreases below a threshold which ensures the return to sport in complete safety.
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