Development of a Global Design Education Experience in Bioengineering Through International Partnerships.

The field of engineering is increasingly appreciating the value of diversity for innovative design solutions. Successful engineering depends on our ability to explore constrained parameter spaces for finding the best solutions, and more diverse minds and experiences enable us to explore the entire potential solution space more thoroughly, more quickly, and more creatively. With a goal to expand the diversity of experiences and mindsets in our undergraduate bioengineering curricula, Arusha Technical College (ATC) in Arusha, Tanzania and Clemson University (CU) in Clemson, South Carolina, U.S., have partnered together over the past 5 years to provide intercontinental educational opportunities for undergraduate students, graduate assistants, and faculty. In 2018, CU and ATC collaborated on an international design course targeting undergraduate students in biomedical engineering focused on global health solutions for resource poor communities. Undergraduate students from ATC and CU collaborated on design projects through formal videoconferenced group meetings, e-mail, and various social media platforms. The year ended with a joint design symposium in Arusha where the students presented on their work in a public poster forum. This successful ATC-CU Global Health Design Collaboration pilot year provides a solid model upon which to build. Students reported overall positive experiences and plans to continue in their curriculum to graduation, as well as some ATC and CU students changing their career direction to include global health initiatives.

Open-wedge high tibial osteotomy: incidence of lateral cortex fractures and influence of fixation device on osteotomy healing.

PURPOSE: Open-wedge high tibial osteotomy (HTO) is an established treatment for young and middle-aged patients with medial compartment knee osteoarthritis and varus malalignment. Although not intended, a lateral cortex fracture might occur during this procedure. Different fixation devices are available to repair such fractures. This study was performed to evaluate osteotomy healing after fixation with two different locking plates. METHODS: Sixty-nine medial open-wedge HTO without bone grafting were followed until osteotomy healing. RESULTS: In patients with an intact lateral hinge, no problems were noted with either locking plate. A fracture of the lateral cortex occurred in 21 patients (30.4 %). In ten patients, the fracture was not recognized during surgery but was visible on the radiographs at the 6-week follow-up. Lateral cortex fracture resulted in non-union with the need for surgical treatment in three out of eight (37.5 %) patients using the newly introduced locking plate (Position HTO Maxi Plate), while this did not occur with a well-established locking plate (TomoFix) (0 out of 13, p = 0.023). CONCLUSION: With regard to other adverse events, no differences between both implants were observed. In cases of lateral cortex fracture, fixation with a smaller locking plate resulted in a relevant number of non-unions. Therefore, it is recommended that bone grafting, another fixation system, or an additional lateral fixation should be used in cases with lateral cortex fracture. LEVEL OF EVIDENCE: III.

Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations.

BACKGROUND: Clinical consequences of alignment errors in total knee replacement (TKR) have led to the rigorous evaluation of surgical alignment techniques. Rotational alignment in the transverse plane has proven particularly problematic, with errors due to component malalignment relative to bone anatomic landmarks and an overall mismatch between the femoral and tibial components' relative positions. Ranges of nominal rotational alignment are not well defined, especially for the tibial component and for relative rotational mismatch, and some studies advocate the use of mobile-bearing TKR to accommodate the resulting small rotation errors. However, the relationships between prosthesis rotational alignment and mobile-bearing polyethylene insert motion are poorly understood. This prospective, in vivo study evaluates whether component malalignment and mismatch affect axial rotation motions during passive knee flexion after TKR. METHODS: Eighty patients were implanted with mobile-bearing TKR. Rotational alignment of the femoral and tibial components was measured from postoperative CT scans. All TKR were categorized into nominal or outlier groups based on defined norms for surgical rotational alignment relative to bone anatomic landmarks and relative rotational mismatch between the femoral and tibial components. Axial rotation motion of the femoral, tibial and polyethylene bearing components was measured from fluoroscopic images acquired during passive knee flexion. RESULTS: Axial rotation motion was generally accomplished in two phases, dominated by polyethylene bearing rotation on the tibial component in early to mid-flexion and then femoral component rotation on the polyethylene articular surface in later flexion. Opposite rotations of the femur-bearing and bearing-baseplate articulations were evident at flexion greater than 80°. Knees with outlier alignment had lower magnitudes of axial rotation and distinct transitions from external to internal rotation during mid-flexion. Knees with femoral-tibial rotational mismatch had significantly lower total axial rotation compared to knees with nominal alignment. CONCLUSIONS: Maintaining relative rotational mismatch within ±5° during TKR provided for controlled knee axial rotation during flexion. TKR with rotational alignment outside of defined surgical norms, with either positive or negative mismatch, experienced measurable kinematic differences and presented different patterns of axial rotation motions during passive knee flexion compared to TKR with nominal mismatch. These findings support previous studies linking prosthesis rotational alignment with inferior clinical and functional outcomes. TRIAL REGISTRATION: Clinical Trials NCT01022099.

Patients with no functional improvement after total knee arthroplasty show different kinematics.

PURPOSE: As many as 20 % of all patients following total knee arthroplasty are not satisfied with the result. Rotational alignment is one factor thought to affect clinical outcome. The purpose of this study was to assess relationships between prosthesis rotational alignment, function score and knee kinematics after TKA. METHODS: In 80 patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform was implanted. Rotational alignment was measured using CT-scans. Kinematics was assessed using fluoroscopy images. RESULTS: Seventy-three patients were available for follow-up after two years. Nine patients had more than 10° rotational mismatch between the femoral and tibial component in the postoperative CT scans. These patients showed significantly worse results in the function score. While the normal patients with less than 10° rotational mismatch improved from a mean pre-operative 55 points to a mean 71 points at follow-up, the group with more than 10° mismatch deteriorated from a mean 60 points pre-operatively to a mean 57 points at follow-up. The pattern of motion during passive flexion from approximately 0° to 120° was quite different. While external rotation steadily increased with knee flexion in the normal group, there was internal rotation between 30° and 80° of flexion in the group with more than 10° rotational mismatch. CONCLUSION: Rotational mismatch between femoral and tibial components exceeding 10° resulted in different kinematics after TKA. It might contribute to worse clinical results observed in those patients and should therefore be avoided.

Patterns of knee osteoarthritis in Arabian and American knees.

This study illustrates differences in the cartilage degeneration in osteoarthritic knees in patients with more frequent hyperflexion activities of daily living compared with Western patients. Proximal tibial articular cartilage wear and cruciate ligament condition were assessed in Saudi Arabian and North American patients with varus osteoarthritis undergoing total knee arthroplasty. In anterior cruciate ligament (ACL) intact knees, there were significant differences in wear location, with a clearly more anterior pattern in Saudi Arabian knees. Complete ACL deficiency occurred in 25% of North American knees but only 14% of Saudi Arabian knees. These ACL-deficient knees showed the most severe cartilage wear in both groups and posterior medial wear patterns. Biomechanical descriptions of knee flexion and axial rotation during kneeling or squatting are consistent with the more pronounced anteromedial and posterolateral cartilage wear patterns observed on the Saudi Arabian knees. These observations provide insight into altered knee mechanics in 2 culturally different populations with different demands on knee flexion.

An in vivo model for intraoperative assessment of impingement and dislocation in total hip arthroplasty.

We have developed an intraoperative model to quantify total hip arthroplasty impingement and dislocation mechanics using fluoroscopy and shape-matching techniques. Two patient groups were investigated: group 1 consisted of 12 hips using 28- or 32-mm femoral heads and an anterolateral surgical approach, and group 2 consisted of 17 hips using 22- or 26-mm femoral heads and a posterolateral surgical approach. During intraoperative hip stability testing consisting of extension and external rotation motions, group 1 was more unstable, and prosthetic impingement was the major reason for dislocation. With flexion and internal rotation motions, group 2 was more unstable, and superior-lateral impingement or soft tissue traction was the major reason for dislocation. Intraoperative quantitative assessment of hip mechanics provides a safe and clinically relevant method to characterize potential complications and evolve techniques to prevent them.

Association between dislocation, impingement, and articular geometry in retrieved acetabular polyethylene cups.

We used a novel analysis technique and retrieved acetabular polyethylene liners to investigate relationships between impingement damage, dislocation history, and polyethylene liner geometry. Forty-eight polyethylene liners with neutral rim elevation were visually assessed for peripheral rim damage consistent with impingement between the liner rim and femoral component. Liner articular geometry was measured using a digital stylus, and the geometric relationships between the liner rim and center of the femoral head were characterized by lip height, head center inset, and head penetration into the polyethylene liner. Thirteen (27%) retrieved liners had rim impingement damage and 12 (25%) had a history of dislocation. The proportion of liners with impingement was not significantly different among dislocated and stable liners. Lip height, head center inset, and head penetration were not significantly different between liners with and without impingement damage. Dislocated liners had a significantly shorter head center inset, with significantly less head penetration because of shorter functional duration. Designing polyethylene liners with a sufficiently deep articular surface that exceeds 0.95 mm may prove beneficial for decreasing the prevalence of early dislocation, independent of impingement damage.

Computational wear prediction of a total knee replacement from in vivo kinematics.

Wear of ultra-high molecular weight polyethylene bearings in total knee replacements remains a major limitation to the longevity of these clinically successful devices. Few design tools are currently available to predict mild wear in implants based on varying kinematics, loads, and material properties. This paper reports the implementation of a computer modeling approach that uses fluoroscopically measured motions as inputs and predicts patient-specific implant damage using computationally efficient dynamic contact and tribological analyses. Multibody dynamic simulations of two activities (gait and stair) with two loading conditions (70-30 and 50-50 medial-lateral load splits) were generated from fluoroscopic data to predict contact pressure and slip velocity time histories for individual elements on the tibial insert surface. These time histories were used in a computational wear analysis to predict the depth of damage due to wear and creep experienced by each element. Predicted damage areas, volumes, and maximum depths were evaluated against a tibial insert retrieved from the same patient who provided the in vivo motions. Overall, the predicted damage was in close agreement with damage observed on the retrieval. The gait and stair simulations separately predicted the correct location of maximum damage on the lateral side, whereas a combination of gait and stair was required to predict the correct location on the medial side. Predicted maximum damage depths were consistent with the retrieval as well. Total computation time for each damage prediction was less than 30 min. Continuing refinement of this approach will provide a robust tool for accurately predicting clinically relevant wear in total knee replacements.

Design and evaluation of a bioreactor with application to forensic burial environments.

Existing forensic taphonomic methods lack specificity in estimating the postmortem interval (PMI) in the period following active decomposition. New methods, such as the use of citrate concentration in bone, are currently being considered; however, determining the applicability of these methods in differing environmental contexts is challenging. This research aims to design a forensic bioreactor that can account for environmental factors known to impact decomposition, specifically temperature, moisture, physical damage from animals, burial depth, soil pH, and organic matter content. These forensically relevant environmental variables were characterized in a soil science context. The resulting metrics were soil temperature regime, soil moisture regime, slope, texture, soil horizon, cation exchange capacity, soil pH, and organic matter content. Bioreactor chambers were constructed using sterilized thin-walled polystyrene boxes housed in calibrated temperature units. Gravesoil was represented using mineral soil (Ultisols), and organic soil proxy for Histosols, horticulture mix. Gravesoil depth was determined using mineral soil horizons A and Bt2 to simulate surface scatter and shallow grave burial respectively. A total of fourteen different environmental conditions were created and controlled successfully over a 90-day experiment. These results demonstrate successful implementation and control of forensic bioreactor simulating precise environments in a single research location, rather than site-specific testing occurring in different geographic regions. Bone sections were grossly assessed for weathering characteristics, which revealed notable differences related to exposure to different temperature regimes and soil types. Over the short 90-day duration of this experiment, changes in weathering characteristics were more evident across the different temperature regimes rather than the soil types. Using this methodology, bioreactor systems can be created to replicate many different clandestine burial contexts, which will allow for the more rapid understanding of environmental effects on skeletal remains.

Clinical Outcomes of Tibial Components with Modular Stems Used in Primary TKA.

Due to the known potential for fretting and corrosion at modular junctions in orthopaedic implants, this retrospective study evaluated radiographic and clinical outcomes of 85 primary TKA patients implanted with modular stemmed tibial components and followed up for an average of 82 months. There was low incidence of tibial radiolucent lines, excellent functional outcomes, and no complications associated with stem modularity. The findings were comparable to the historical control study involving 107 TKA with a nonmodular tibial stem design. When using surface cemented tibial components combined with a constrained polyethylene bearing, modular stems appear to be a viable option for primary TKA when adequate fixation and rotational stability are maintained.

Total knee arthroplasty designed to accommodate the presence or absence of the posterior cruciate ligament.

Evidence for selecting the same total knee arthroplasty prosthesis whether the posterior cruciate ligament (PCL) is retained or resected is rarely documented. This study reports prospective midterm clinical, radiographic, and functional outcomes of a fixed-bearing design implanted using two different surgical techniques. The PCL was completely retained in 116 knees and completely resected in 43 knees. For the entire cohort, clinical knee (96 ± 7) and function (92 ± 13) scores and radiographic outcomes were good to excellent for 84% of patients after 5-10 years in vivo. Range of motion averaged 124° ± 9°, with 126 knees exhibiting ≥120° flexion. Small differences in average knee flexion and function scores were noted, with the PCL-resected group exhibiting an average of 5° more flexion but an average function score that was 7 points lower compared to the PCL-retained group. Fluoroscopic analysis of 33 knees revealed stable tibiofemoral translations. This study demonstrates that a TKA articular design with progressive congruency in the lateral compartment can provide for femoral condyle rollback in maximal flexion activities and achieve good clinical and functional performance in patients with PCL-retained and PCL-resected TKA. This TKA design proved suitable for use with either surgical technique, providing surgeons with the choice of maintaining or sacrificing the PCL.

Repeatable procedure for evaluating taper damage on femoral stems with modular necks.

Understanding the performance of dual-taper modular femoral stems necessitates detailed quantitative assessment. This study reports a repeatable procedure to identify and measure damage on modular taper surfaces and determines whether damage area is a useful parameter for discerning modular femoral stem performance during in vitro corrosion and endurance tests. Twenty-four dual-taper modular necks representing a range of functional conditions were evaluated, including 15 necks previously subjected to in vitro testing and 9 necks explanted during revision hip arthroplasty. Objective identification of six surface features, including four unique damage modes, was accomplished using defined criteria combined with a standardized photogrammetric method for accurate and repeatable measurement of damage area and location. Damage area was a useful parameter for discerning the performance of modular femoral stems subjected to different in vitro tests. The sum of burnished smooth and textured damage areas was linearly correlated with the magnitude of material removed (weight loss) during in vitro testing, predicting ∼ 1.0 mg additional weight loss for every 10% increase in those combined damage areas. Modular necks tested with higher load magnitudes and those coupled with larger, stiffer femoral stems were readily distinguished and showed significantly larger areas of burnished smooth and textured damage.

Use of a deep polyethylene liner for the treatment of recurrent dislocation.

Modular component exchange is one of several viable options for treating instability after total hip arthroplasty (THA). Recently, we reported that polyethylene liners retrieved from stable THAs had significantly deeper cup articular geometry than liners retrieved from dislocated THAs. Modular liner exchange with implantation of a deeper cup articulation for the treatment of THA instability may be an option in certain cases. We describe the use of modular liner exchange with implantation of a custom polyethylene liner with a deepened articular geometry for surgical treatment of recurrent dislocation after primary THA in a 70 year old patient. The patient did not feel unstable and no symptoms of subluxation or dislocation have been experienced in the 3 years of follow-up subsequent to treatment. Surgeons should consider the articular geometry of the polyethylene liner as an important design parameter, and we recommend that deeper polyethylene liners be considered for treatment of recurrent dislocation after primary THA.

Polyethylene damage and deformation on fixed-bearing, non-conforming unicondylar knee replacements corresponding to progressive changes in alignment and fixation.

BACKGROUND: Deviations from nominal alignment of unicondylar knee replacements impact knee biomechanics, including the load and stress distribution at the articular contact surfaces. This study characterizes relationships between the biomechanical environment, distinguished by progressive changes in alignment and fixation, and articular damage and deformation in a consecutive series of retrieved unicondylar knee replacements. METHODS: Twenty seven fixed-bearing, non-conforming unicondylar knee replacements of one design were retrieved after 2 to 13 years of in vivo function. The in vivo biomechanical environment was characterized by grading component migration measured from full-length radiographs and grading component fixation based on intraoperative manual palpation. Articular damage patterns and linear deformation on the polyethylene inserts were measured using optical photogrammetry and contact point digitization. FINDINGS: Articular damage patterns and surface deformation on the explanted polyethylene inserts corresponded to progressive changes in component alignment and fixation. Component migration produced higher deformation rates, whereas loosening contributed to larger damage areas but lower deformation rates. Migration and loosening of the femoral component, but not the tibial component, were factors contributing to large regions of abrasion concentrated on the articular periphery. INTERPRETATION: Classifying component migration and fixation at revision proved useful for distinguishing common biomechanical conditions associated with the varied polyethylene damage patterns and linear deformation for this fixed-bearing, non-conforming design. Pre-clinical evaluations of unicondylar knee replacements that are capable of reproducing variations in clinical alignment and predicting the observed wear mechanisms are necessary to better understand the impact of knee biomechanics and design on unicondylar knee replacement longevity.

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 simulator's 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.

Backside damage corresponding to articular damage in retrieved tibial polyethylene inserts.

Although motion between the polyethylene insert and tibial baseplate is one probable cause of backside wear, articular contact stresses and kinematic conditions may be additional factors. However, comparisons of articular and backside damage patterns are limited. We report the effect of physiologic loading on the modular capture mechanism and distribution of articular and backside surface damage patterns on retrieved tibial components. We evaluated damage patterns on 37 tibial inserts with a full peripheral rim capture mechanism, including six autopsy-retrieved components that were not previously disassembled and were available for mechanical testing. The duration of physiologic loading affected the modular capture mechanism and damage patterns. Backside damage revealed evidence of a mechanical interlock between the polyethylene insert and tibial tray consistent with the measured insert motion. In autopsy components retrieved after 2 to 6 years, inserts with the least motion had the longest duration of in vivo function and the largest backside damage area. The backside damage area and location corresponded to articular damage with damage patterns concentrated on the posterior half of the polyethylene inserts. Substantial differences between the articular and backside damage modes suggest different wear mechanisms exist at the two interfaces during physiologic loading.

Closed reduction of constrained total hip arthroplasty.

Many surgeons use acetabular components with constrained polyethylene liners to improve stability in patients with a history of hip dislocation. Considering that the reported incidence of hip dislocation in patients with constrained components is 4% to 29%, it generally is recognized that open reduction would likely be necessary in cases of redislocation. Recent reports have indicated that closed reduction of constrained total hip arthroplasty is possible in some cases. However, it is unknown whether closed reduction damages the constrained polyethylene liner and predisposes patients to additional dislocations. The current study evaluated the integrity of the polyethylene constraint mechanism after in vitro simulation of hip dislocation and closed reduction. After lever-out dislocation and reduction, 76% of the capture mechanism strength was maintained without additionally damaging the polyethylene liner. Also reported is the technique for closed reduction in patients with constrained components and a clinical series of six patients who had successful closed reduction. These patients remain stable without any additional dislocations 7 to 72 months after reduction. These data suggest that closed reduction of Poly-Dial constrained polyethylene liners can be successful without predisposing patients to additional dislocations.