Materials and Methods

Medical grade UHMWPE was molded together with vancomycin at 2, 4, 6, 8, 10 and 14 wt%. Tensile mechanical testing and impact testing were performed to determine the effect of drug content on mechanical properties. Elution of the drug was performed in phosphate buffered saline (PBS) for up to 8 weeks and the detection of the drug in PBS was done by UV-Vis spectroscopy. A combination of vancomycin and rifampin in UHMWPE was developed to address chronic infection and layered construct containing 1 mm-thick drug-containing UHMWPE in the non-load bearing regions was developed for delivery. In a lapine (rabbit) intra-articular model (n=6 each), two plug of the layered UHMWPE construct were placed in the trochlear grove of the rabbit femoral surface and a porous titanium rod with a pre-grown biofilm of bioluminescent S. Aureus was implanted in the tibia. Bioluminescent imaging was employed to visualize and quantify the presence of the bacteria up to 3 weeks.

Materials and Methods

Skeletally mature adult male New Zealand White rabbits received either two non-antibiotic eluting UHMWPE (CONTROL, n=5) or vancomycin-eluting UHMWPE (TEST, n=5) (3 mm in diameter and 6 mm length) in the patellofemoral groove (Fig. 1). All rabbits received a beaded titanium rod in the tibial canal (4 mm diameter and 12 mm length). Both groups received two doses of 5 × 10⁷ cfu of bioluminescent S. aureus (Xen 29, PerkinElmer 119240) in 50 µL 0.9 % saline in the following sites: (1) distal tibial canal prior to insertion of the rod; (2) articular space after closure of the joint capsule (Fig. 1). None of the animals received any intravenous antibiotics for this study. Bioluminescence signal (photons/second) was measured when the rabbits expired, or at the study endpoint (day 21). The metal rods were stained with BacLight^® Bacterial Live-Dead Stain and imaged using two-photon microscopy to detect live bacteria. Hardware, polyethylene implants and joint tissues were sonicated to further quantify live bacteria via plate seeding.

Methods

The average uniaxial stiffness (350 N/mm), and average dimensions (width × thickness = 14mm × 4mm) of 10 cadaver psoas tendon samples were determined in a separate study. The iliopsoas tendon was modelled as a Yeoh hyper-elastic material, and the material constants were tuned to match the experimental uniaxial test data. Cadaver specific FEA models were created for 5 specimens (10 hips) using computed tomography (CT) scans. The implant components were modeled as being rigid relative to the iliopsoas tendon. The iliopsoas tendon was modelled as extending from its insertion point on the lesser trochanter to the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. Appropriately sized DM components were implanted virtually for each specimen. Once placed in its proper position, the liner was rotated about the flexion axis until it contacted the stem posteriorly to represent its orientation during hip extension (Fig. 2). A 500N tensile load was applied to the iliopsoas tendon and the average/max stresses within the tendon, and average/max contact pressures between the tendon and liner were measured.

Methods

Eleven patient with advanced medial knee osteoarthritis (age: 51–73 years) who scheduled for a CR TKA and 9 knees from 8 healthy subjects (age: 23–49 years) were recruited. 3D models of the tibia and femur were created from their MR images. Dual fluoroscopic images of each knee were acquired during a weight-bearing single leg lunge. The OA knee was imaged again one year after surgery using the fluoroscopy during the same weight-bearing single leg lunge. The in vivo positions of the knee along the flexion path were determined using a 2D/3D matching technique. The GCA and sTEA were determined based on existing methods. Besides the anterior-posterior translation, the femoral condyle heights were determined using the distances from the medial and lateral epicondyle centers on the sTEA and GCA to the tibial plateau surface in coronal plane (Fig. 1). The paired t-test was applied to compare the medial and lateral condyle motion within each group (Healthy, OA, and CR-TKA). Two-way ANOVA followed post hoc Newman–Keuls test was adopted to detect significant differences among the groups. p<0.05 was considered significant.

Methods

48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05).

METHODS

Kinematic performance of the biomimetic BCR design (asymmetric tibia with convex lateral surface), a contemporary BCR implant (symmetric shallow dished tibia) and a contemporary CR implant (symmetric dished tibia) was analyzed using KneeSIM software. Chair-sit, deep knee bend, and walking were analyzed. Components were mounted on an average bone model created from magnetic resonance imaging (MRI) data of 40 normal knees. Soft-tissue insertions were defined on the average knee model based on MRI data, and mechanical properties were obtained from literature. Femoral condyle center motions relative to the tibia were tracked to compare different implant designs.

Methods

The interaction of conventional and contoured liners with anterior soft-tissues was evaluated in 10 cadaveric hips (5 specimens; 2 male, 3 female; age 65 ± 10 yrs; liner diameter 42–48mm) via visual observation and fluoroscopic imaging. A metal wire was sutured to the deep fibers of the iliopsoas tendon/muscle, and metal wires were embedded in the mobile liners for fluoroscopic visualization (Fig. 2). All soft-tissue except the anterior hip capsule and iliopsoas was removed, and a rope was attached to the iliopsoas to apply tension along its natural orientation.

Resistance to inner-head pull-out was evaluated via Finite Element Analysis (FEA) by simulating a full cycle of insertion of the inner head into the mobile liner and subsequent pullout. The femoral head, acetabular shell, and stem were modeled as rigid, while the mobile liner was modeled as plastically deformable. Hip joint stability was evaluated by dynamic simulations in for two dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal hip rotation; (B) Posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction. A 44 mm diameter conventional and a 44 mm contoured liner were evaluated during these tests.

Methods

The finite element model was developed within COMSOL 4.3b. The psoas tendon was modelled as a Yeoh hyper-elastic Material, which uses 3 constants (c1-c3), density (1.73g/cm3) and a bulk modulus (26GPa)[Hirokawa,2000]. In a previous, separate study, the average stiffness of 10 psoas tendon samples (5 cadavers), were measured to be 339[N/mm] in the linear region with average width and thickness of 14mmX4mm. The 3 constants were tuned to match experimental uniaxial test data, and were 5[GPa], 0[Gpa], and 46[GPa] for c1, c2, and c3 respectively.

The implant components were rigidly modeled relative to the psoas. Cadaver specific CT models were used to create the FEA geometry. The insertion points for the Psoas were digitally determined on the proximal end of the lesser trochanter, and the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. These insertion points determined the length of the psoas and its relative position to the femoral head in 3D. The specific liner size and position for each cadaver was determined by implant planning with the CT models. In this abstract, we only present data for 2 specimens (left/right hips) with 44mm conventional DM, and 44mm ACDM, matching specimen anatomy. A 500N tensile load was applied to the psoas tendon proximally to simulate moderate physiological loading, the average/max stresses and contact pressures between the psoas and the two liner designs were determined.

METHODS

Cadaver knees were positioned with the ACL oriented along the loading axis and being the only connection between femur and tibia. 15° knee flexion was selected based on highest ACL tensions reported in literature. Therefore, the fixtures were adjusted accordingly to retain 15° knee flexion when the ACL was tensioned. The test protocol included 10 cycles of preconditioning between 6N and 60N at 1mm/s, followed by continuous distraction at 1mm/s until failure (Fig. 1). Eleven cadaveric knees (4 male, 7 female; 70.9 yrs +/−13.9 yrs) were tested using this setup to characterize a baseline ACL pullout strength (peak load to failure) in native knees.