A Novel Bio-Adhesive Mesh System for Medical Implant Applications: In Vivo Assessment in a Rabbit Model.

Injectable surgical sealants and adhesives, such as biologically derived fibrin gels and synthetic hydrogels, are widely used in medical products. While such products adequately adhere to blood proteins and tissue amines, they have poor adhesion with polymer biomaterials used in medical implants. To address these shortcomings, we developed a novel bio-adhesive mesh system utilizing the combined application of two patented technologies: a bifunctional poloxamine hydrogel adhesive and a surface modification technique that provides a poly-glycidyl methacrylate (PGMA) layer grafted with human serum albumin (HSA) to form a highly adhesive protein surface on polymer biomaterials. Our initial in vitro tests confirmed significantly improved adhesive strength for PGMA/HSA grafted polypropylene mesh fixed with the hydrogel adhesive compared to unmodified mesh. Toward the development of our bio-adhesive mesh system for abdominal hernia repair, we evaluated its surgical utility and in vivo performance in a rabbit model with retromuscular repair mimicking the totally extra-peritoneal surgical technique used in humans. We assessed mesh slippage/contraction using gross assessment and imaging, mesh fixation using tensile mechanical testing, and biocompatibility using histology. Compared to polypropylene mesh fixed with fibrin sealant, our bio-adhesive mesh system exhibited superior fixation without the gross bunching or distortion that was observed in the majority (80%) of the fibrin-fixed polypropylene mesh. This was evidenced by tissue integration within the bio-adhesive mesh pores after 42 days of implantation and adhesive strength sufficient to withstand the physiological forces expected in hernia repair applications. These results support the combined use of PGMA/HSA grafted polypropylene and bifunctional poloxamine hydrogel adhesive for medical implant applications.

Analyzing material changes consistent with degradation of explanted polymeric hernia mesh related to clinical characteristics.

BACKGROUND: Proposed mechanisms that potentially contribute to polypropylene mesh degradation after in vivo exposure include oxidizing species and mechanical strains induced by normal healing, tissue integration, muscle contraction, and the immediate and chronic inflammatory responses. METHODS: This study explores these potential degradation mechanisms using 63 mesh implants retrieved from patients after a median implantation time of 24 months following hernia repair surgery (mesh explants) and analysis of multivariate associations between the material changes and clinical characteristics. Specifically, polypropylene mesh degradation was characterized in terms of material changes in surface oxidation, crystallinity and mechanical properties, and clinical characteristics included mesh placement location, medical history and mesh selection. RESULTS: Compared to pristine control samples, subsets of mesh explants had evidence of surface oxidation, altered crystallinity, or changed mechanical properties. Using multivariate statistical approach to control for clinical characteristics, infection was a significant factor affecting changes in mesh stiffness and mesh class was a significant factor affecting polypropylene crystallinity changes. CONCLUSIONS: Highly variable in vivo conditions expose mesh to mechanisms that alter clinical outcomes and potentially contribute to mesh degradation. These PP mesh explants after 0.5 to 13 years in vivo had measurable changes in surface chemistry, crystallinity and mechanical properties, with significant trends associated with factors of mesh placement, mesh class, and infection.

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.

The effect of manufacturing tolerances on the mechanical environment of taper junctions in modular TKR.

Taper design is known to influence corrosive behavior in taper junctions used in modular orthopaedic devices. Manufacturing tolerance of bore-cone tapers is a critical design parameter due to the effect on taper fit, but the effect of variations in manufacturing tolerance on the mechanics of taper junctions has not been well characterized, particularly in modular total knee replacement (TKR). The purpose of this study was to investigate the effect of manufacturing tolerance on stress and micromotion of modular TKR taper junctions. A 3D finite element (FE) model of a modular TKR taper junction was developed and assigned elastoplastic material properties. Model taper geometry was varied by perturbing the angle mismatch by 0.05° between ±0.25° and represented expected variation in manufacturing tolerance. Stress and micromotion were calculated during dynamic FE simulations for each taper junction geometry under varying activity loads and material combinations. Although an increase in angle mismatch generally resulted in higher stress and micromotion, plastic material behavior disrupted this trend for larger angle mismatches. Model predictions corresponded with corrosion behavior evident in vitro. If the FE results obtained here apply in vivo, the absence of elastoplastic material properties in a taper model may grossly overestimate the micromotion and underestimate corrosion behavior and ion release. It is recommended that manufacturing tolerances of bore-cone tapers in modular TKR designs should produce angle mismatches within 0.1° at the taper junction.

VERIFICATION OF MANUAL DIGITIZATION METHODS DURING EXPERIMENTAL SIMULATION OF KNEE MOTION.

Cadaveric testing is a common approach for verifying mathematical models used in computational modeling work. In the case of a knee joint model for calculating ligament tension during total knee replacement (TKR) motion, model inputs include rigid body motions defined using the Grood-Suntay coordinate system as a spatial linkage between the tibial component orientation relative to the femoral component. Using this approach requires the definition of coordinate systems for each rigid TKR component (i.e. tibial and femoral) based on fiducial points, manual digitization of a point cloud within the experimental setup, and registration of the orientation relative to the relevant bone marker array. The purpose of this study was to compare the variability between two different manual point digitization methods (a hand-held stylus and pivot tool each calibrated in the optical tracking system), using a TKR femoral component in a simulated cadaver limb experimental setup as an example. This was accomplished by verifying the mathematical algorithm used to calculate the coordinate system from the digitized points, quantifying the variability of the manual digitization methods, and discussing how any error could affect the computational model. For the hand-held stylus method, the standard deviation of the origin and, x-, y-, and z-axis calculations were 0.50mm, 1.31 degrees, 0.51 degrees, and 0.62 degrees, respectively. It is important to note that there is an additional error created using the hand-held stylus from required manual digitization of each rigid marker array. This average additional error was 0.54mm for the origin and 1.70, 1.66, and 0.98 degrees for the x-, y-, and z-axes, respectively. For the pivot tool method, the standard deviation was 0.35mm, 0.37 degrees, 1.27 degrees, and 1.24 degrees for the origin, x-, y-, and z-axes, respectively. It is essential to minimize experimental error, as small errors in alignment can substantially alter model outputs. In this study of cadaver simulation of limb motion, the pivot tool is the better option for minimizing error. Careful definition of fiducial points and repeatable manual digitization of the point cloud is critical for meaningful computational models of TKR motion based on cadaver experimental work.

Surface modification of polypropylene surgical meshes for improving adhesion with poloxamine hydrogel adhesive.

Tissue adhesive has notable clinical benefits in hernia repair fixation. A novel poloxamine tissue adhesive was previously shown to successfully bond collagen tissue with adequate adhesive strength. In application related to attachment of polypropylene (PP) mesh, the adhesive strength between the mesh and poloxamine hydrogel adhesive is limited by the hydrophobicity of PP monofilaments and lack of covalent bond formation. The purpose of this study was to compare two different surface modifications [bovine serum albumin (BSA) adsorption and poly-glycidyl methacrylate/human serum albumin (PGMA/HSA) grafting] of PP mesh for improving the adhesive strength between poloxamine hydrogel adhesive and PP mesh. The PGMA/HSA surface modification significantly improved the adhesive strength for meshes attached with poloxamine hydrogel tissue adhesive compared with unmodified meshes and meshes modified by BSA adsorption. An area of 1 cm2 adhesive provided for a maximum adhesive strength of 65-70 kPa for meshes modified by PGMA/HSA, 4-13 kPa for meshes modified by BSA, and 22-45 kPa for unmodified meshes. Optical microscopy and infrared spectroscopy (FTIR) confirmed the improved adhesive strength was achieved through mechanical interlock of the hydrogel tissue adhesive into the PP mesh pores and chemical bonding of the albumin after successful PGMA/HSA grafting onto the PP monofilaments. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1047-1055, 2019.

Single-Use Bag Valve Masks: Evaluation of Device Design and Residual Bioburden Analytical Methods.

BACKGROUND: A recent survey of in-hospital reprocessing in Tanzanian hospitals identified bag-valve masks (BVM) as a commonly reused single-use device. In low- and middle-income countries (LMIC), in-hospital reprocessing supports neonatal resuscitation strategies by helping to maintain adequate supplies of BVM. However, there is a need for device-specific protocols defining reprocessing procedures and inspection criteria to overcome variations in reprocessing practices between hospitals. The purposes of this study were: 1) to complete a comprehensive design review and identify challenges to reprocessing BVMs; and 2) to investigate three different residual bioburden analysis methods for assessing the efficacy of decontaminating a disposable BVM. METHODS: New, unused bag-valve-masks were contaminated with Staphylococcus epidermidis and Artificial Mucus Soil to simulate the worst case soiling conditions. Devices underwent one of five disinfection protocols, including one currently used in a LMIC hospital. Three analytical (two quantitative and one qualitative) methods were selected to evaluate residual bioburden on the device following decontamination. RESULTS: Of all protocols tested, only the positive control and the Soap and Bleach protocols met disinfection targets. Most cleaning outcomes were consistent from trial to trial for each protocol. However, cleaning outcomes varied greatly for the Alcohol Wipe protocol. For the residual bioburden analyses, the two quantitative methods produced similar results, but the qualitative measurement exhibited increased variability. CONCLUSION: While this study revealed positive disinfection outcomes for the Tanzanian hospital decontamination protocol, more studies are required to support these findings. Design features of the BVM mask presented challenges to cleaning and drying during different decontamination protocols, as seen in the variability in the Alcohol Wipe protocol performance. These findings support the case for a device-specific protocol for the BVM. Given proper hospital personnel training and available resources, in-hospital reprocessing could support neonatal resuscitation strategies and other demands for manual resuscitation by helping to maintain adequate supplies of BVM.

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.

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.

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.

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.

Treatment for Wear and Osteolysis in Well-Fixed Uncemented TKR.

Background. Traditionally, osteolysis around total knee replacements (TKRs) is treated with complete revision. In certain subsets, polyethylene insert exchange and bone grafting may be applicable. This study reports the clinical outcomes for selective bone grafting in patients with osteolysis without complete revision of the TKR. Methods. This retrospective study analyzes 10 TKRs (9 patients, 66.5 ± 6.1 years old) presenting with osteolysis and revised after 8.7 ± 1.9 years of in vivo function. At index TKR, all patients were implanted with uncemented prosthesis and modular polyethylene insert with anteroposterior articular constraint (Ultracongruent, Natural Knee II, Sulzer Medica). The surgical technique for treating the osteolysis included removal of necrotic bone tissue using curettage, filling of the defect with bone graft materials, and polyethylene insert exchange. Results. Patients have not exhibited any further complications associated with osteolysis after 5.1 ± 2.4 years of followup. Routine radiographic exams show total incorporation of the graft material into the previously lytic regions in all patients. Conclusion. In some TKRs with osteolysis and firmly fixed components, the removal of lytic tissue and subsequent defect filling with bone graft materials can be a viable solution. This case series shows complete resolution of osteolysis in all patients with no complications.

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.

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.

A pictographic atlas for classifying damage modes on polyethylene bearings.

Evaluation of medical devices retrieved after in vivo service provides unique evidence related to the physiological environment in which the biomaterials performed. This study implements a training procedure for evaluating polyethylene bearings of joint prostheses obtained after pre-clinical tests or explanted after in vivo function. A total of 161 damage regions on 45 bearings were evaluated by four observers. An illustrated Damage Mode Atlas was developed as a reference guide, inclusive of both photographs and concise written descriptions of 16 specific damage modes that are typical for polyethylene bearings. Utilizing the Damage Mode Atlas to train new researchers improved the damage pattern analysis, including more accurate identification of damage modes and improved inter-rater reliability. This Damage Mode Atlas is a useful supplementary tool for conducting Stage II non-destructive analysis of explanted polyethylene bearings used for joint replacement, in accordance with international guidelines for evaluating explanted medical devices.

Re-use of explanted osteosynthesis devices: a reliable and inexpensive reprocessing protocol.

INTRODUCTION: Orthopaedic surgical treatments emphasizing immobilization using open reduction and internal fixation with osteosynthesis devices are widely accepted for their efficacy in treating complex fractures and reducing permanent musculoskeletal deformity. However, such treatments are profoundly underutilized in low- and middle-income countries (LMIC), partially due to inadequate availability of the costly osteosynthesis devices. Orthopaedic surgeons in some LMIC regularly re-use osteosynthesis devices in an effort to meet treatment demands, even though such devices typically are regulated for single-use only. The purpose of this study is to report a reprocessing protocol applied to explanted osteosynthesis devices obtained at a leading trauma care hospital. METHODS: Explanted osteosynthesis devices were identified through a Register of Explanted Orthopaedic Prostheses. Guidelines to handle ethical issues were approved by the local Ethical Committee and informed patient consent was obtained at the time of explant surgery. Primary acceptance criteria were established and applied to osteosynthesis devices explanted between 2005 and 2008. A rigorous protocol for conducting decontamination and visual inspection based on specific screening criteria was implemented using simple equipment that is readily available in LMIC. RESULTS: A total of 2050 osteosynthesis devices, including a large variety of plates, screws and staples, were reprocessed using the decontamination and inspection protocols. The acceptance rate was 66%. Estimated labour time and implementation time of the protocol to reprocess a typical osteosynthesis unit (1 plate and 5 screws) was 25 min, with an estimated fixed cost (in Italy) of €10 per unit for implementing the protocol, plus an additional €5 for final sterilization at the end-user hospital site. DISCUSSION: This study was motivated by the treatment demands encountered by orthopaedic surgeons providing medical treatment in several different LMIC and their need for access to basic osteosynthesis devices. The rigorous decontamination protocol and generalized inspection criteria proved useful for efficiently screening a large volume of devices. Given that re-used osteosynthesis devices can yield satisfactory results, this study addresses potential complications of re-used devices and valid concerns that relate to patient safety. Implementing this defined reprocessing protocol into existing re-use practises in LMIC helps to limit the risks of inadequate sterilization and structural failure without adding additional risks to patients receiving re-used devices.

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.