John D. DesJardins

The use of a force-controlled dynamic knee simulator to quantify the mechanical performance of total knee replacement designs during functional activity

The experimental evaluation of any total knee replacement (TKR) design should include the pre-implantation quantification of its mechanical performance during tests that simulate the common activities of daily living. To date, few dynamic TKR simulation studies have been conducted before implantation. Once in vivo, the accurate and reproducible assessment of TKR design mechanics is exceedingly difficult, with the secondary variables of the patient and the surgical technique hindering research. The current study utilizes a 6-degree-of-freedom force-controlled knee simulator to quantify the effect of TKR design alone on TKR mechanics during a simulated walking cycle. Results show that all eight TKR designs tested elicited statistically different measures of tibial/femoral kinematics, simulated soft tissue loading, and implant geometric restraint loading during an identical simulated gait cycle, and that these differences were a direct result of TKR design alone. Maximum ranges of tibial kinematics over the eight designs tested were from 0.8mm anterior to 6.4mm posterior tibial displacement, and 14.1 degrees internal to 6.0 degrees external tibial rotation during the walking cycle. Soft tissue and implant reaction forces ranged from 106 and 222N anteriorly to 19 and 127N posteriorly, and from 1.6 and 1.8Nm internally to 3.5 and 5.9Nm externally, respectively. These measures provide valuable experimental insight into the effect of TKR design alone on simulated in vivo TKR kinematics, bone interface loading and soft tissue loading. Future studies utilizing this methodology should investigate the effect of experimentally controlled variations in surgical and patient factors on TKR performance during simulated dynamic activity.

Comparison of polyethylene tibial insert damage from in vivo function and in vitro wear simulation.

Function and wear of total knee arthroplasties were compared by analysis of damage patterns on polyethylene tibial inserts retrieved from patients (Group R) with inserts obtained after in vitro force‐controlled knee joint wear simulation. Two simulator input profiles were evaluated, including standard walking (Group W), and combined walking and stair descent (Group W + S), simulating varied activities and a more severe physiological environment. Damage regions on all inserts were quantitatively assessed. On average, inserts in all groups had internally rotated damage patterns and the greatest articular deformation in the lateral compartment. These patterns were more pronounced in Group W + S compared to Group W. Deformation rates of simulated inserts were analogous to about six years of physiologic function. However, both groups of simulated inserts generally underestimated the magnitude of damage area and extent observed on retrieved inserts, consistent with differences in the simulators tibiofemoral contact mechanics and those known to occur in patients during functional activities. Modification of simulator inputs, such as the increased anteroposterior excursion and more severe loading conditions in Group W + S, can generate greater wear volume, larger damage areas, and increased surface deformation rates compared to standard inputs.

Effect of stair descent loading on ultra-high molecular weight polyethylene wear in a force-controlled knee simulator

Abstract A loading protocol approximating forces, torques and motions at the knee during stair descent was developed from previously published data for input into a force-controlled knee simulator. A set of total knee replacements (TKRs) was subjected to standard walking cycles and stair descent cycles at a ratio of 70:1 for 5 million cycles. Another set of implants with similar articular geometry and the same ultra-high molecular weight polyethylene (UHMWPE) resin (GUR 415), sterilization and packaging was tested with standard walking cycles only. Implant kinematics, gravimetric wear and surface roughness of the UHMWPE inserts were analysed for both sets of implants. Contact stresses were calculated for both loading protocols using a Hertzian line contact model. Significantly greater weight loss (p < 0.05) and more severe surface damage of UHMWPE inserts resulted with the walking + stair descent loading protocol compared to walking cycles only. Anterior-posterior (AP) tibiofemoral contact point displacements were lower during stair descent than walking, but not significantly different (p = 0.05). Contact stresses were significantly higher during stair descent than walking, owing to higher axial loads and the smaller radius of curvature of the femoral components at higher flexion angles. High contact stresses on UHMWPE components are likely to accelerate the fatigue of the material, resulting in more severe wear, similar to what is observed in retrieved implants. Thus the inclusion of loading protocols for activities of daily living in addition to walking is warranted for more realistic in vitro testing of TKRs.

A repeatable alignment method and local coordinate description for knee joint testing and kinematic measurement

A method for aligning cadaver knee specimens to a mechanical testing rig and determining local anatomical coordinate systems using landmarks identifiable on plane X-rays is introduced. Three sequential rotational alignments arc used to position the femur and tibia relative to the coordinate system of the testing mechanism. To validate this methodology five independent observers aligned the same knee specimen. The maximum error in the alignment orientations of the tibia and femur was 2.2 from the mean. These small misalignments produced variations of up to 4.7 in tibio-femoral rotations measured during knee flexion. Kinematic measurements of 15 specimens aligned using this procedure indicate that knee alignment is reproducible and physiologically relevant.

The Quantification of Physiologically Relevant Cross-Shear Wear Phenomena on Orthopaedic Bearing Materials Using the MAX-Shear Wear Testing System

Background: The occurrence of multi-directional sliding motion between total knee replacement bearing surfaces is theorized to be a primary wear and failure mechanism of ultra-high molecular weight poly(ethylene) (UHMWPE). To better quantify the tribologic mechanisms of this cross-shear wear, the MAX-Shear wear-testing system was developed to evaluate candidate biomaterials under controlled conditions of cross-shear wear. Method of approach: A computer controlled traveling x-y stage under a 3 degree-of-freedom statically loaded pin is used to implement the complex multi-directional motion pathways observed during TKR wear simulation. A MHz collection of dynamic x-y friction was available on all six environmentally controlled stations. The functionality of this testing platform was proven in a 100,000 cycle, 11.6 MPa, wear test using 15.0 mm diameter polished stainless steel spheres against flat GUR4150 UHMWPE. A five-pointed star wear pattern was used to incorporate the physiologically relevant cross-shear sliding conditions of stop/start, 50mm∕s entraining velocity and five crossing angles of 72°. Using normalized volumetric reconstruction of the resulting surface damage, a direct quantitative relationship between linear and cross-shear surface damage intensity was obtained. Results: Cross-shear surface damage volume loss was found to be 2.94 (±0.88) times that associated with linear sliding under identical tribologic conditions. SEM analysis of linear wear damage showed consistent fibril orientation along the direction of sliding while cross-shear wear damage showed multi-directional fibril orientations and increased surface roughness. Significant increases in discrete crossing-point friction coefficients were recorded throughout testing. Conclusions: This scientific approach to quantifying the tribologic effects of cross-shear provides fundamental wear mechanism data that are critical in evaluating potential biomaterials for use as in vivo bearings. Relevant multi-axis, cross-shear wear testing is necessary to provide quantifiable measures of complex biomaterials wear phenomena.

Effects of Patient and Surgical Alignment Variables on Kinematics in TKR Simulation Under Force-Control

Simulation of total knee replacement (TKR) is typically achieved by integrating sliding/rolling motions and loads between the implants articulating surfaces during an activity cycle such as walking. Clinically, however, important variations in implant alignment and duty occur due to variability in patient anatomy/arthritic deformity, compounded by choices or errors in surgical installation. This study investigated the effects of the activity cycle severity, frontal plane alignment, relative femoral/tibial component rotational position, and the tightness of the posterior cruciate ligament (PCL). Seven different (four fixedbearing and three mobile-bearing) cruciate-retaining TKRs with different inherent constraints were tested on a force-control knee simulator. As well as the ISO standard wave forms for walking, an Enhanced Duty Cycle was used. The resulting anterior-posterior displacements and axial rotations were increased with the Enhanced Duty Cycle. Changing the line of action of the compressive force in the frontal plane (varus-valgus over/under-correction) did not appreciably change the kinematics. Rotating the tibial component shifted the rotational curves in the same direction as the misalignment. The PCL tightness produced the most noticeable effect on kinematics; a tight PCL reduced both displacements and rotations, and a loose PCL did the opposite.

Development of luminescent pH sensor films for monitoring bacterial growth through tissue

Although implanted medical devices (IMDs) offer many benefits, they are susceptible to bacterial colonization and infections. Such infections are difficult to treat because bacteria could form biofilms on the implant surface, which reduce antibiotics penetration and generate local dormant regions with low pH and low oxygen. In addition, these infections are hard to detect early because biofilms are often localized on the surface. Herein, an optical sensor film is developed to detect local acidosis on an implanted surface. The film contains both upconverting particles (UCPs) that serve as a light source and a pH indicator that alters the luminescence spectrum. When irradiated with 980 nm light, the UCPs produce deeply penetrating red light emission, while generating negligible autofluorescence in the tissue. The basic form of the pH indicator absorbs more of upconversion luminescence at 661 nm than at 671 nm and consequently the spectral ratio indicates pH. Implanting this pH sensor film beneath 6-7 mm of porcine tissue does not substantially affect the calibration curve because the peaks are closely spaced. Furthermore, growth of Staphylococcus epidermidis on the sensor surface causes a local pH decrease that can be detected non-invasively through the tissue.

The Effect of Intercondylar Notchplasty on the Patellofemoral Articulation

Using pressure-sensitive film, we measured the patel lofemoral contact areas and pressures after increasing degrees of notchplasty in eight fresh-frozen cadaveric knee specimens. Each specimen was stabilized on an axial loading frame with physiologic loads applied through the quadriceps tendon at varying flexion an gles. The patellofemoral joint was loaded at 90°, 105°, and 120° of knee flexion. The same measurements were then obtained after serial notchplasties of 3, 6, and 9 mm. The film was analyzed for contact areas and for contact pressures by densitometry. There was no statistical significance between contact area or pres sure after notchplasties of 3, 6, or 9 mm at 90°, 105°, and 120° of knee flexion. These data suggest that routine notchplasty does not affect the patellofemoral articulation.

Increased Conformity Offers Diminishing Returns for Reducing Total Knee Replacement Wear

Wear remains a significant problem limiting the lifespan of total knee replacements (TKRs). Though increased conformity between TKR components has the potential to decrease wear, the optimal amount and planes of conformity have not been investigated. Furthermore, differing conformities in the medial and lateral compartments may provide designers the opportunity to address both wear and kinematic design goals simultaneously. This study used a computational model of a Stanmore knee simulator machine and a previously validated wear model to investigate this issue for simulated gait. TKR geometries with different amounts and planes of conformity on the medial and lateral sides were created and tested in two phases. The first phase utilized a wide range of sagittal and coronal conformity combinations to blanket a physically realistic design space. The second phase performed a focused investigation of the conformity conditions from the first phase to which predicted wear volume was sensitive. For the first phase, sagittal but not coronal conformity was found to have a significant effect on predicted wear volume. For the second phase, increased sagittal conformity was found to decrease predicted wear volume in a nonlinear fashion, with reductions gradually diminishing as conformity increased. These results suggest that TKR geometric design efforts aimed at minimizing wear should focus on sagittal rather than coronal conformity and that at least moderate sagittal conformity is desirable in both compartments.

Bi-unicondylar knee prosthesis functional assessment utilizing force-control wear testing

Abstract Recent in vivo studies have identified variations in knee prosthesis function depending on prosthesis geometry, kinematic conditions, and the absence/presence of soft-tissue constraints after knee replacement surgery. In particular, unicondylar knee replacements (UKR) are highly sensitive to such variations. However, rigorous descriptions of UKR function through experimental simulation studies, performed under physiological force-controlled conditions, are lacking. The current study evaluated the long-term functional performance of a widely used fixed-bearing unicompartmental knee replacement, mounted in a bi-unicondylar configuration (Bi-UKR), utilizing a force-controlled knee simulator during a simulated (ISO 14243) walking cycle. The wear behaviour, the femoral—tibial kinematics, and the incurred damage scars were analysed. The wear rates for the medial and the lateral compartments were 10.27 ± 1.83 mg/million cycles and 4.49 ± 0.53 mg/million cycles, respectively. Although constant-input force-controlled loading conditions were maintained throughout the simulation, femoral—tibial contact point kinematics decreased by 65 to 68 per cent for average anterior/posterior travel and by 58 to 74 per cent for average medial/lateral travel with increasing cycling time up to 2 million cycles. There were no significant differences in damage area or damage extent between the medial and the lateral compartments. Focal damage scars representing the working region of the femoral component on the articular surface extended over a range of 16—21 mm in the anterior—posterior direction. Kinematics on the shear plane showed slight variations with increasing cycling time, and the platform exhibited medial pivoting over the entire test. These measures provide valuable experimental insight into the effect of the prosthesis design on wear, kinematics, and working area. These functional assessments of Bi-UKR under force-controlled knee joint wear simulation show that accumulated changes in the UKR articular conformity manifested as altered kinematics both for anterior/posterior translations and internal/external rotations.