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Research Papers

Biomechanical Robustness of a Contemporary Cementless Stem to Surgical Variation in Stem Size and Position

[+] Author and Article Information
Rami M. A. Al-Dirini

Medical Device Research Institute,
College of Science and Engineering,
Flinders University,
Adelaide 5043, Australia
e-mail: rami.aldirini@flinders.edu.au

Dermot O'Rourke, Saulo Martelli

Medical Device Research Institute,
College of Science and Engineering,
Flinders University,
Adelaide 5043, Australia

Daniel Huff

DePuy Synthes,
Johnson and Johnson,
Warsaw, IN 46581

Mark Taylor

Medical Device Research Institute,
College of Science and Engineering,
Flinders University,
Adelaide 5043, Australia
e-mail: mark.taylor@flinders.edu.au

1Corresponding author.

Manuscript received September 2, 2017; final manuscript received March 18, 2018; published online May 24, 2018. Assoc. Editor: Tammy L. Haut Donahue.

J Biomech Eng 140(9), 091007 (May 24, 2018) (12 pages) Paper No: BIO-17-1389; doi: 10.1115/1.4039824 History: Received September 02, 2017; Revised March 18, 2018

Successful designs of total hip replacement (THR) need to be robust to surgical variation in sizing and positioning of the femoral stem. This study presents an automated method for comprehensive evaluation of the potential impact of surgical variability in sizing and positioning on the primary stability of a contemporary cementless femoral stem (Corail®, DePuy Synthes). A patient-specific finite element (FE) model of a femur was generated from computed tomography (CT) images from a female donor. An automated algorithm was developed to span the plausible surgical envelope of implant positions constrained by the inner cortical boundary. The analysis was performed on four stem sizes: oversized, ideal (nominal) sized, and undersized by up to two stem sizes. For each size, Latin hypercube sampling was used to generate models for 100 unique alignment scenarios. For each scenario, peak hip contact and muscle forces published for stair climbing were scaled to the donor's body weight and applied to the model. The risk of implant loosening was assessed by comparing the bone–implant micromotion/strains to thresholds (150 μm and 7000 με) above which fibrous tissue is expected to prevail and the periprosthetic bone to yield, respectively. The risk of long-term loosening due to adverse bone resorption was assessed using bone adaptation theory. The range of implant positions generated effectively spanned the available intracortical space. The Corail stem was found stable and robust to changes in size and position, with the majority of the bone–implant interface undergoing micromotion and interfacial strains that are well below 150 μm and 7000 με, respectively. Nevertheless, the range of implant positions generated caused an increase of up to 50% in peak micromotion and up to 25% in interfacial strains, particularly for retroverted stems placed in a medial position.

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Figures

Grahic Jump Location
Fig. 1

The automated algorithm positioned the Corail stem into the femur. In this figure, the white space within the bone represents the inner cortex, while the gray shape represents the femoral stem. The horizontal lines illustrate the cross sections from which the points defining the shaft axes of the femur were selected. These were taken at 20 and 80% of the stem length, measured from the distal tip of the stem. It is worth noting that these cross sections were not identical for the four stems studied as the length of the stem changes with size. The top part of this figure shows the nominal stem position. To introduce variation in the anterior/posterior and the varus/valgus alignment of the stem within the “plausible implantable space,” the location of the points defining the shaft axis were varied. This is illustrated in the bottom part of the figure, where the nodes showing the original position in the nominal position were moved (as indicated by the arrows) resulting in a more valgus stem position.

Grahic Jump Location
Fig. 2

An illustration showing the five parameters used to describe the position of the femoral stem. These included three angular and two linear parameters. The angular parameters were the anteversion of the stem (Antevangle), the varus/valgus orientation of the stem (V-Vangle) and the anterior/posterior orientation of the stem (A-Pangle). The translational parameters were the medial/lateral offset of the trunnion center (shown by the black dot in this figure) from the femoral shaft axis (ML OffsetIMP) and the superior/inferior offset of the trunnion center from the lesser trochanter (SI OffsetIMP). All translational parameters were in millimeters (mm) and all angular parameters were in degrees (deg). The right-hand side of this figure shows the different stem sizes used in this study.

Grahic Jump Location
Fig. 3

A summary of the primary stability measures for the nominal position only. The first column to the right presents the oversized stem, the second column to the right presents the nominal-sized stem, the second column to the left presents the undersized stem by single size, and the first column to the left presents the undersized stem by two size. The measures of primary stability were micromotion, in microns (top row), interface strains, in microstrains (middle row), and the percentage of the contact area undergoing high and low remodeling signal (bottom row). Regions where micromotion and interface strains exceeded 150 μm and 7000 με, respectively, are displayed in red, while regions where micromotion was below 50 μm, or interface strains were below 2000 με are displayed in blue. The blue in the last row highlights regions with high remodeling stimuli (>75%), indicative of bone apposition and red for regions with low remodeling stimuli (< −75%), indicative of bone resorption. Please refer to the online version for the colored version of the figure.

Grahic Jump Location
Fig. 4

A summary of the five parameters describing the various stem positions in this study for four different stem sizes. All measurements were taken relative to the nominal position illustrated in Figs. 1 and 2. This figure shows the implanted femur with all stem positions and sizes considered, with the black nodes representing bone and the blue nodes are for the stem geometry. For each of the stem size shown, the figure shows a top view, left view, and front view, as well as two cross-sectional views of the femoral shaft.

Grahic Jump Location
Fig. 5

Micromotion (top) and interfacial strain (bottom) profiles under stair climb loads for the 100 stem positions for each of the four different stem sizes (from left to right): (i) undersized stem by two sizes and (ii) undersized stem by one size, (iii) nominal size, and the oversized stem. The figure presents box plots for the 50th (left) and the 90th percentiles (right), with thresholds for fibrous tissue formation (top) and peri-prosthetic bone damage (bottom), which is undesirable for THA, superimposed on the plots. Thresholds within which osseointegration is expected were also superimposed in the top plot. Statistically significant differences are shown with (*).

Grahic Jump Location
Fig. 6

The top part of the figure shows the distribution of the percentage of bone contacting the stem with strains exceeding bone-damage threshold (> 7000 με, left) and micromotion exceeding threshold within which fibrous tissue formation is expected (> 150 μm, right) for the 100 stem positions for each of the four different stem sizes (left to right): (i) undersized stem by two sizes and (ii) undersized stem by one size, (iii) nominal size and the oversized stem. The bottom part of the figure presents box plots for the percentage of periprosthetic bone under catabolic (left) and anabolic (right) remodeling stimuli. Statistically significant differences are shown with (*).

Grahic Jump Location
Fig. 7

Results for the categorical comparison for the 90th micromotion percentile groups, MG1 (left of each plot) and MG2 (right of each plot), where MG1 and MG2 were models with 90th percentile micromotion less than and greater than that of the nominal size and position (μmNSP = 104.8 μm), respectively. The figure only shows positioning parameters (Antevangle and ML OffsetIMP) with significant differences (p < 0.05) for each of the four different stem sizes: (i) undersized stem by two sizes (top left) and (ii) undersized stem by one size (top right), (iii) nominal size (bottom right) and the oversized stem (bottom left).

Grahic Jump Location
Fig. 8

Results for the categorical comparison for the 90th interface strain percentile groups, SG1 (left of each plot) and SG2 (right of each plot), where SG1 and SG2 were models with 90th percentile interfacial strains less than and greater than that of the nominal size and position (μεNSP = 5450 με), respectively. The figure only shows positioning parameters (Antevangle and ML OffsetIMP) with significant differences (p < 0.05) for each of the four different stem sizes: (i) undersized stem by two sizes (top left) and (ii) undersized stem by one size (top right), (iii) nominal size (bottom right) and the oversized stem (bottom left).

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