Knee Surg Sports Traumatol Arthrosc DOI 10.

1007/s00167-010-1289-8

KNEE

A mechanized and standardized pivot shifter: technical description and rst evaluation
Musa Citak Eduardo M. Suero Joshua C. Rozell Marianne Roberta Frederiek Bosscher Julian Kuestermeyer Andrew D. Pearle

Received: 24 June 2010 / Accepted: 21 September 2010 Springer-Verlag 2010

Abstract Purpose The pivot shift test (PST) is a complex, multiplanar maneuver used to assess rotatory instability of the knee. The grading is subjective due to the broad range of examination techniques and lack of tibiofemoral motion quantication. The goal of this study was to develop and evaluate a mechanized device for quantitative assessment of the PST. Methods We constructed a mechanized pivot shifter (MPS). In ve cadaveric hip-to-toes specimens, the anterior cruciate ligament was resected. We used a surgical navigation system for acquisition of the tibiofemoral motion path during the PST. Two sets of measurements were obtained for the MPS and for two examiners performing the manual technique. Results Mean lateral compartment translation magnitudes for each MPS measurement were 13.5 mm (r = 6.7) and 13.6 mm (r = 6.7). For examiner 1, 14.9 mm (r = 6.5) and 15.7 mm (r = 6.3). For examiner 2, 16.9 mm (r = 6.3) and 16.1 mm (r = 5.2). Differences were not significant (n.s.). The MPS had narrower limits of agreement than both examiner 1 and examiner 2. Conclusion The MPS demonstrated no signicant differences in the tibiofemoral translation magnitudes compared to the manual technique. It resulted in better testretest reliability and more consistent measurements of
A. D. Pearle (&) Hospital for Special Surgery, 535 E 70th St., 10021 NY, USA e-mail: PearleA@hss.edu M. Citak E. M. Suero J. C. Rozell M. R. F. Bosscher J. Kuestermeyer A. D. Pearle Department of Orthopaedic Surgery, Hospital for Special Surgery, NY, USA

tibiofemoral translation when compared to manual PST. The high repeatability factor conferred by the MPS is a clinical advantage. Keywords Pivot shift CAOS ACL

Introduction In 1845, Amedee Bonnet rst described the association between clinical instability of the knee and anterior cruciate ligament (ACL) injury [3]. Smith rst described the rotational component of an unstable knee in 1918 [28]. Twenty years later, Palmer described a dynamic, circular rotation of the lateral condyle around the more constrained medial compartment during exion in an ACL-insufcient knee [25]. Slocum and Larson described the rst physical examination test for rotatory instability of the knee by adding an external rotation motion of the lower leg to the anterior drawer maneuver [27]. An increase in tibiofemoral translation with 15 external rotation, in comparison with the conventional anterior drawer, was deemed a positive test. Galway et al. described the rst connection between instability of the knee in two planes and ACL injuries [8]. These authors utilized the term pivot shift in the description of the anterolateral rotatory instability and described the rst pivot shift test [8]. In the last decades, many modications of the pivot shift test were published [1, 9, 10, 20, 24, 30]. Today, we know that the pivot shift test is a better predictor of clinical outcomes, patient satisfaction and return to sports after ACL reconstruction than uniplanar examination maneuvers, such as the Lachman [11, 15, 19]. However, the Lachman remains the most commonly used test for assessing ACL deciency and knee instability in clinical practice. The Lachman test is a simple

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maneuver for assessing anteroposterior tibiofemoral translation that can be objectively measured using the KT-1000 (MEDmetric, San Diego, CA) or other instruments [21]. The pivot shift test is a complex, dynamic, multiplanar maneuver [26, 30]. The broad range of examination techniques, the different execution of the test by each examiner and the grading after evaluation are all subjective without a motion-tracking device [1, 10, 17, 20, 24, 26, 30]. The goal of this study was to develop and evaluate a new mechanized device with optoelectronical motion tracking for standardized quantitative assessment of the pivot shift test.

Materials and methods Mechanized pivot shifter design The design of the pivot shifter was based on a continuous passive motion device (CPM), which is often utilized in orthopedic surgery (Fig. 1). The body of the mechanized pivot shifter was constructed using aluminum. It consists of a horizontal base plate (Fig. 1, No. 1) on top of which two linear bearing rails are xed in parallel arrangement (Fig. 1, No. 2). A leg driver component slides longitudinally along the linear bearing rails (Fig. 1, No. 4). It is comprised of a xation device for the foot (Fig. 1, No. 6) attached to a rotatory piece using four long threaded rods (Fig. 1, No. 1). The length of the tibial portion of the mechanized pivot shifter can be adjusted to the patients limb length by dialing the adjustable nuts over the threaded rods. The position of the knee joint line must match that of the pivot shifters joint (Fig. 1, No. 3). With a locking

device, the leg can be turned a maximum 45 internally or externally (Fig. 2, No. 1). To introduce the valgus force, a three-degree-of-freedom (3DoF) arm is utilized (Fig. 1, No. 7). An axial load cell (Lafayette Manual Muscle Test System, Lafayette Instrument Co., USA, Lafayette, IN, USA) (Fig. 1, No. 8) is attached to the 3DoF arm and used to measure the exact valgus force. A preliminary study demonstrated that the best position for the valgus force is 510 cm below the knee joint, with the force vector located in the coronal plane from lateral to medial (Fig. 1, No. 9, red arrow). To assist the leg during the motion from 10 exion to 70 exion, a band attached below the proximal third of the lower leg is utilized (Fig. 1, No. 10). The thigh remains unxed throughout the entire motion path. Two plastic handles are attached to the distal part of the pivot shifter: one on the base plate (Fig. 2, No. 3) and one on the leg driver component of the pivot shifter (Fig. 2, No. 2). To perform the test, the examiner pulls on the handle of the base plate (Fig. 2, No. 3) and pushes the handle on the sliding portion of the pivot shifter, effectively stabilizing the device (Fig. 2, No. 2). The leg exes as the leg driver slides proximally. The 3DoF arm and the axial load cell follow the same motion path of the leg, so as to maintain the correct positioning of the load-measuring device. Cadaveric testing Five fresh frozen cadaveric hip-to-toe lower extremity specimens were utilized for this study (ten paired knees). Specimens were thawed for 48 h at room temperature prior to testing. After testing one leg, the specimens were stored in a cold room overnight and the contralateral extremity

Fig. 1 Second-generation Pivot shifter: 1 base plate, 2 linear bearing rail system, 3 joint, 4 leg driver component, 5 threaded rod, 6 xation device for the foot, 7 three-degree-of-freedom arm, 8 axial load cell

Fig. 2 Second-generation Pivot shifter: 1 rotation locking device, 2 handle leg driver component, 3 handle base plate

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was tested the following day [22]. During the testing procedure, room temperature was consistently kept at 71.6F and was not changed [31]. Specimens were placed supine on an operating room table. This position allowed for free, unrestricted range of motion at the hip and knee. A medial parapatellar arthrotomy of the knee was performed and the anterior cruciate ligament (ACL) was resected using a No. 15 scalpel. An optoelectronic surgical navigation system (Surgetics, Praxim, Grenoble, France) with dedicated ACL software was used for kinematic data acquisition. Reference markers were xed with Steinman pins in the distal femur and proximal tibia (Fig. 3). An infrared camera tracked reective markers as described in previous reports [4, 6]. Surface landmarks were recorded, intraarticular surface geometry was mapped, and a three dimensional (3D) model of the knee was created [29]. The accuracy of this system is extremely precise and can track the movement and position of instruments within 1 mm and 1. With the ACL intact, the knee was manually cycled from full extension to 90 of exion with a proximally directed axial force to keep the tibial and femoral condyles in contact at all positions. This represented the reference exion extension path from which the deviation was measured during each pivot shift examination in the ACL decient knee. During the pivot shift test, the navigation system recorded the 3D motion path of three tracked points located at the center of the tibia, center of the medial tibial plateau, and center of the lateral tibial plateau. Motion of the tibial points was analyzed throughout a given motion path with respect to a tracked central point in the notch of the femur. ACL-specic software of the navigation system allowed for comparison of the motion path during the pivot shift with the reference motion path of exionextension [6, 18]. Maximum tibial translation during the pivot shift maneuver is reported as the difference between reference motion path and pivot shift motion path, in the medial, lateral, and central compartments, respectively.

Manual and mechanized pivot shift tests were performed by two examiners (ES and MC). Two sets of measurements were obtained. The manual pivot shift test was performed as described by Galway and McIntosh, and as modied by Bach et al. with the hip in 45 of abduction [1, 7]. Statistical analysis Statistical analysis was performed using GraphPad Prism 5 (GraphPad Software, Inc., La Jolla, CA). One-way ANOVA was used to detect differences in mean lateral compartment translation between examiners. Intraobserver testretest reliability was assessed using intraclass correlation coefcient and with the method described by Bland and Altman to calculate the bias and the 95% limits of agreement (LoA) for lateral compartment anteroposterior translation magnitudes [2].

Results Mean lateral compartment anteroposterior translation magnitude using the mechanized pivot shifter was 13.5 mm for the rst measurement (r = 6.7) and 13.6 mm for the second measurement (r = 6.7). For examiner 1, the mean measurements were 14.9 mm (r = 6.5) and 15.7 mm (r = 6.3). For examiner 2, lateral compartment translation was measured at a mean 16.9 mm (r = 6.3) and 16.1 mm (r = 5.2). The mean translation magnitude elicited the mechanized pivot shifter was not signicantly different than those elicited by either examiner (n.s.). The mechanized pivot shifter demonstrated narrower LoA (-0.7, 0.5 mm; bias, -0.1; r = 0.3) and better ICC (0.99) when compared to both examiner 1 (LoA = -4.5 mm, 2.9 mm; bias, -0.8; r = 1.9; ICC = 0.95) and examiner 2 (-4.7 mm, 6.3 mm; bias, 0.8; r = 2.8; ICC = 0.88) (Fig. 4).

Discussion The most important nding of this study was that a navigated mechanized pivot shift test had higher testretest reliability when compared to the standard manual pivot shift test. Clinical examination tests for the evaluation of knee laxity in ACL decient knees must be divided into two important groups. The rst group includes those maneuvers that are uniplanar in nature, such as the Lachman test [5, 12]. These tests assess instability in the sagittal plane. They are simple tests, which can be objectively measured by the using the KT-1000 (MEDmetric, San Diego, CA) or other instruments [21]. A second group is composed of

Fig. 3 Setup: the examiner is pushing the handle of the foot driver component and pulling the handle of the base plate

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Fig. 4 BlandAltman plot showing intraobserver agreement for the mechanized pivot shifter and each examiner

multiplanar maneuvers like the pivot shift test [17, 20, 26]. These tests assess tibiofemoral joint instability in both the sagittal and transverse planes. The complex nature of the test permits the examiner to feel the subluxation and subsequent reduction that occurs during the pivot shift phenomenon of the knee. The examiner can identify any existent rotational instability and grade it following a subjective system. Computer navigation made it possible to quantify the magnitude of tibiofemoral translation during a pivot shift examination and to visualize a pathologic motion path that can signify the presence of a positive pivot shift [18]. However, the high interobserver variability of the pivot shift examination as well as the broad range of examination techniques limits the repeatability of a quantitative pivot shift [16, 17, 23]. Evaluation of the pivot shift test is thus difcult to assess as a result of clinician subjectivity [32]. This investigation describes the design and function of the second generation of a mechanized pivot shifter and report on the rst cadaveric examinations with the application of a standardized valgus force. In the rst published version of the mechanized pivot shifter, a conventional CPM device was used [23]. It was not possible to quantify the valgus force with this device. The design of the second-generation pivot shifter was optimized for the pivot shift maneuver. It allows for internal or external tibial rotation, which is an important part of the examination. We were able to exactly measure the applied valgus force using an axial load cell. The vector of the valgus force could be easily adjusted to the optimal position using a 3-degree-of-freedom arm. This force vector, in combination with an optoelectronic surgical navigation system, permitted the measurement of lateral and medial tibiofemoral translation, as well as live visualization of the pivot shift phenomenon (Fig. 5a, b). The presence of a positive pivot shift was conrmed in the ACL decient state in each knee by the characteristic P-shaped pathologic motion path visualized in the sagittal plane (Fig. 5a, b). It has been previously demonstrated that this aberrant P-shaped motion path occurs only when the examiner elicits a positive pivot shift [6, 18].

Fig. 5 Screenshot p-shape during a positive pivot shift: a manual pivot shift, b mechanized pivot shift

The rst-generation mechanized pivot shifter consistently under-estimated the magnitude of translations and rotation [23]. The second-generation device demonstrated no signicant differences in the magnitude of tibiofemoral translation compared to a human examiner. A limitation of the clinical use of the mechanized pivot shifter is that the motion is tracked using a computer navigation system that requires insertion of pins into the bone. Future technology may solve these problems. Noninvasive reference markers are currently used in trauma applications for determining the antetorsion angle of healthy femurs [13, 14]. These bands are xed with Velcro to the distal part of the femur. It is not allowed to move the leg during measurement. Further studies are needed to analyze the behavior of these bands, the accuracy of the results, and their possible use in navigated ACL applications. However, the utility of the MPS could be applied to clinical practice in a day-by-day setting to improve quantication of the pivot shift and accuracy of ACL functional measurements.

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Future investigations will focus on integrating forcesmoment sensors to further improve the mechanized pivot shift test.

Conclusion This study demonstrates that the new version of the mechanized pivot shifter records no signicant differences in tibiofemoral translation magnitude when compared to the manual technique. The high repeatability factor conferred by the mechanized pivot shifter is a clinical advantage. The new device may increase consistency of clinical grading of the pivot shift test.

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