The Morphologic Patella Entry Point Into The Proximal Trochlea Is More Lateral in Recurrent Dislocators Than Controls as Measured by Entry Point-Trochlear Groove Angle.

PURPOSE: The purpose of this work is to create a metric for evaluating the degree of laterality of the patella's entry into the trochlea, the entry point-trochlear groove (EP-TG) angle, and to evaluate if this laterality is associated with recurrent patella instability. METHODS: The time frame of the study was January 2020 to February 2023. The inclusion criteria were patients treated by the senior author (JPF) (with the exception of two patients who were treated by another provider at the institution who was aware of the study) who have been diagnosed with recurrent atraumatic patellar dislocations. Controls without knee pathology were selected from the New Mexico Decedent Imaging Database (NMDID). Simpleware ScanIP was used to create three-dimensional (3D) models of the distal femurs from CT scans. AP images of these 3D models were uploaded to a custom EP-TG angle measuring tool. Three measurers used the tool to measure the EP-TG angle of the distal femurs. RESULTS: 28 patients were included for the recurrent dislocator group. 24 decedents from NMDID were selected for the control group, each with a left or right knee chosen randomly for measurement. A one-sided Mann-Whitney U test, used to evaluate whether the recurrent dislocators had higher EP-TG angle values, yielded a p value <0.001, demonstrating a high level of significance. A Bayesian mixed effect model, used to determine how different the EP-TG angles are between the two groups, gave a posterior predictive interval (PPI) of [11.93, 19.12] degrees for the EP-TG angle shift of dislocators. The intraclass correlation coefficient was 0.648. CONCLUSIONS: The morphological entry point of the patella into the proximal trochlea is more lateral in recurrent patella dislocators than in controls. This increased laterality can be measured by EP-TG angle, which may be useful information for optimizing treatment of recurrent patella instability. LEVEL OF EVIDENCE: Level III Case Control Study.

Three-Dimensional Imaging of the Patellofemoral Joint Improves Understanding of Trochlear Anatomy and Pathology and Planning of Realignment.

Three-dimensional (3-D) modeling using digital or printed models provides a unique perspective that caters to cognitive spatial ability in a way that can add to our understanding and mental representations of human anatomy. This is particularly useful in the setting of trochlear dysplasia, where the morphology of the groove can exhibit substantial variability and complexity. Using 3-D reformatted images and models, a pragmatic understanding of how morphology influences patellofemoral pathology can be gleaned. Further, this perspective facilitates cognition of what patellar tracking may look like after realignment procedures. Using 3-D modeling, concepts such as patella alta, trochlear depth, lateralization of the patellar entry point, trochlear curvature, and the presence of a proximal trochlear spur can help afford a better understanding of how trochlear anatomy may influence tracking while also providing insight as to the ideal tracking path. The use of 3-D has recently emerged as a useful tool in multiple surgical subspecialties, particularly in situations involving surgical planning or complex anatomy. Given the complexity and variation in trochlear morphology in patients with trochlear dysplasia who develop either patellar instability or focal overloading, 3-D modeling is well-suited to provide a perspective that can add to our understanding of trochlear dysplasia, and potentially even how we diagnose and treat it.

Outcomes of Distal Third Femur Fractures in Patients 18 Years and Older: A Pilot Study.

INTRODUCTION: The selection of the most optimal fixation method for fractures of the distal femur, whether intramedullary nail (NL), lateral locking plate (PL), or nail/plate (NP) is not always clear. This study retrospectively evaluates surgical patients with distal femur fractures and introduces a pilot study using cluster analysis to identify the most optimal fracture fixation method for a given fracture type. METHODS: This is a retrospective cohort study of patients 18 years and older with an isolated distal femur fracture who presented to our Level-1 trauma center between January 1, 2012, and December 31, 2022, and obtained NL, PL, or NP implants. Patients with polytrauma and those without at least six months of follow-up were excluded. A chart review was used to obtain demographics, fracture classification, fixation method, and postoperative complications. A cluster analysis was performed. The following factors were used to determine a successful outcome: ambulatory status pre-injury and 6-12 months postoperatively, infection, non-union, mortality, and implant failure. RESULTS: A total of 169 patients met inclusion criteria. No statistically significant association between the fracture classification and fixation type with overall outcome was found. However, patients treated with an NP (n = 14) had a success rate of 92.9% vs only a 68.1% success rate in those treated with a PL (n = 116) (p = 0.106). The most notable findings in the cluster analysis (15 total clusters) included transverse extraarticular fractures demonstrating 100% success if treated with NP (n = 6), 50% success with NL (n=2), and 78.57% success with PL fixation (n=14). NP constructs in complete articular fractures demonstrated success in 100% of patients (n = 5), whereas 77.78% of patients treated with NL (n = 9) and 61.36% of those treated with PL (n = 44). CONCLUSIONS: Plate fixation was the predominant fixation method used for distal third femur fractures regardless of fracture classification. However, NP constructs trended towards improved success rates, especially in complete intraarticular and transverse extraarticular fractures, suggesting the potential benefit of additional fixation with these fractures. Cluster analysis provided a heuristic way of creating patient profiles in patients with distal third femur fractures. However, a larger cohort study is needed to corroborate these findings to ultimately develop a clinical decision-making tool that also accounts for patient specific characteristics.

A review of the design, manufacture, and outcomes of custom total joint replacement implants available in the United States.

Custom total joint replacement (TJA) implants, specifically designed and manufactured for each patient, have emerged as surgeons seek to improve functional outcomes of primary total joint replacement, as well as treat patients with complex primary deformities, bone defects, and revision surgeries. The purpose of this review is to present the various custom total hip and knee arthroplasty implants available in the United States for primary and revision cases, so that surgeons can understand the design considerations and manufacturing processes of custom implants, as well as their performance compared to standard implants.

Three-Dimensional Printing of Models of Patellofemoral Joint Articular Cartilage in Patients With Patella Instability for Observing Joint Congruity.

Three-dimensional (3D) modeling and printing are increasingly used in the field of orthopaedic surgery for both research and patient care. One area where they are particularly helpful is in improving our understanding of the patellofemoral (PF) joint. Heretofore, morphological studies that use 3D models of the PF joint have primarily been based on computed tomography imaging data and thus do not incorporate articular cartilage. Here, we describe a method for creating 3D models of the articular surfaces of the PF joint based on magnetic resonance imaging. Models created using this technique can be used to improve our understanding of the morphology of the articular surfaces of the PF joint and its relationship to joint pathologies. Of particular interest is our finding of articular congruity in printed articular cartilage surfaces of dysplastic PF joints of recurrent patella dislocators.

An analytical model of lateral condylar plate working length.

BACKGROUND: The locking plate is a common device to treat distal femur fractures. Healing is affected by construct stiffness, thus many surgeon-controlled variables such as working length have been examined for their effects on strain at the fracture. No convenient analytical model which aids surgeons in determining working length has yet been described. We propose an analytical model and compare it to finite element analysis and cadaveric biomechanical testing. METHODS: First, an analytical model based on a cantilever beam equation was derived. Next, a finite element model was developed based on a CT scan of a "fresh-frozen" cadaveric femur. Third, biomechanical testing in single-leg stance loading was performed on the cadaver. In all methods, strain at the fracture was recorded. An ANCOVA test was conducted to compare the strains. FINDINGS: In all models, as the working length increased so did strain. For strain at the fracture, the shortest working length (35 mm) had a strain of 8% in the analytical model, 9% in the finite element model, and 7% for the cadaver. The longest working length (140 mm) demonstrated strain of 15% in the analytical model, and the finite element and biomechanical tests both demonstrated strain of 14%. INTERPRETATION: The strain predicted by the analytical model was consistent with the strain observed in both the finite element and biomechanical models. As demonstrated in existing literature, increasing the working length increases strain at the fracture site. Additional work is required to refine and establish validity and reliability of the analytical model.

Three-Dimensional Reproductions for Surgical Decision-Making in the Treatment of Recurrent Patella Dislocation.

Patellofemoral instability may be attributed to a variety of soft tissue and osseous factors, of which dysplasia of the femoral trochlea significantly predisposes patients to recurrent instability events. Surgical planning and decision-making remain wholly predicated upon two-dimensional imaging-derived measurements and classification systems, although aberrant patellar tracking in the setting of trochlea dysplasia is a three-dimensional (3-D) complexity. 3-D reconstructions of the patellofemoral joint (PFJ) may be considered to better comprehend the complex anatomy of patients with recurrent patella dislocation and/or trochlea dysplasia. We describe a classification and integrated interpretation system by which these 3-D reproductions of the PFJ may be analyzed to enhance surgical decision making in the treatment of this condition to achieve optimal joint stability and long-term preservation.

Three-Dimensional Printing of the Patellofemoral Joints of Patellar Instability Patients.

Three-dimensional (3D) modeling and printing comprise an important tool for orthopaedic surgeons. One area in which 3D modeling has the potential to dramatically improve our understanding of biomechanical kinematics is pathologies of the patellofemoral joint, in particular trochlear dysplasia. We describe a method for creating 3D printed models of the patellofemoral joint, including computed tomography image acquisition, image segmentation, model creation, and 3D printing. The models created can help surgeons understand and plan surgery for recurrent patellar dislocations.

Simulating Prophylactic Fixation Methods for Osteoporotic Femoral Neck Fracture Prevention.

Introduction: Geriatric patients who suffer femoral neck fractures have high morbidity and mortality. Prophylactic fixation of the femoral neck is a potential avenue to reduce the incidence of femoral neck fractures. We studied 3 different implants traditionally used to stabilize the femoral neck: 6.5 mm cannulated screws (CANN), the femoral neck system (FNS) (Depuy Synthes), and the dynamic hip screw (DHS) (Depuy Synthes). Materials and Methods: Five osteoporotic Sawbone femurs were used for each model and a control group. Two scenarios were investigated: single leg stance to measure construct stiffness and lateral impact to measure construct stiffness, energy to fracture, and qualitative examination of fracture patterns. Stiffness for each femur and energy to fracture for the lateral impact scenario were calculated and compared between groups using one-way ANOVA. Results: DHS showed significantly higher stiffness than the other 2 implants and the control in single leg stance. In the lateral impact scenario, the DHS and CANN were significantly stiffer FNS and the control. Femurs implanted with CANN tended to fracture at the greater trochanter while FNS fractured in a transverse subtrochanteric pattern, and DHS fractured obliquely in the subtrochanteric region. Discussion: FNS and DHS experienced fracture patterns less amenable to surgical correction. CANN and DHS proved better able to resist external forces in the lateral fall scenario. CANN also proved better able to resist external forces in the single leg stance scenario and experienced a more amenable fracture pattern in the lateral fall scenario. Conclusions: FNS was less able to resist external forces compared with the other implants. This work informs the potential implications between the choice of implants that, although historically have not been used prophylactically, may be considered in the future for prophylactic stabilization of the femoral neck. Cadaveric study and clinical trials are recommended for further study.

Reconceptualization of Trochlear Dysplasia in Patients With Recurrent Patellar Dislocation Using 3-Dimensional Models.

Background: Common classification schemes, measurements, and surgical planning for trochlear dysplasia are predicated on 2-dimensional imaging views. Purpose: To investigate patellofemoral joint osseous anatomy using 3-dimensional (3D) printed models to describe osseous anatomic trochlear variations in patients with recurrent patellar dislocation. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Computed tomography scans were obtained from 20 patients with recurrent patellar dislocation and 10 healthy control knees, and 3D prints generated from these computed tomography scans were studied with respect to mediolateral positioning of the proximal trochlear groove and groove obliquity as well as changes in the appearance, height, and orientation of the medial and lateral trochlear ridges. Each trochlea was centered with respect to a vertical line perpendicular to the distal femoral condyles and through the central intercondylar notch roof, with the 3D models resting on their posterior femoral condyles. A novel 3D measurement method was devised to assess groove obliquity, termed the entry point-transition point (EP-TP) angle. The EP was defined as the midpoint of the flattened region of the proximal trochlea where the lateral and medial ridges of the proximal trochlea meet, and the TP was the point along the trochlear groove at which the groove shape changes from an oblique orientation proximally to one more vertical distally. Measurements were obtained by 3 reviewers, and reliability analyses were performed. Results: With the dysplastic knees arranged according to flattening of the trochleas, increased obliquity of the trochlear grooves was observed, as reflected by increased EP-TP angles as well as more lateral patellar EPs into the proximal trochleas of these recurrent patellar dislocation knees when compared with the control knees. The degree of trochlear dysplasia (according to the Dejour classification and trochlear flatness in the frontal and axial planes) was associated with diminished prominence of the lateral trochlear convexity, increasingly lateralized proximal trochlear EPs, increased trochlear groove obliquity, lateral trochlear curvature, and progressive medial ridge deformity. Conclusion: The 3D reproductions enabled unique conceptualization of trochlear deformity associated with recurrent patellar dislocation.

Evaluating surface coatings to reduce bone cement adhesion to point of care 3D printed molds in the intraoperative setting.

BACKGROUND: Polymethyl methacrylate, or "bone cement," can be used intraoperatively to replace damaged or diseased bone and to deliver local antibiotics. 3D printed molds allow surgeons to form personalized and custom shapes with bone cement. One factor hindering the clinical utility of anatomically accurate 3D printed molds is that cured bone cement can be difficult to remove due to the strong adhesion between the mold and the bone cement. One way to reduce the adhesion between the 3D printed mold and the cured bone cement is with the use of a surface coating, such as a lubricant. This study sought to determine the optimal surface coating to prevent bone cement adhesion to 3D printed molds that could be utilized within a sterile operating room environment. METHODS: Hemispheric molds were 3D printed using a stereolithography printer. The molds were coated with four sterile surface coatings available in most operating theatres (light mineral oil, bacitracin ointment, lubricating jelly, and ultrasound transmission gel). Polymethyl methacrylate with tobramycin antibiotic was mixed and poured into the molds. The amount of force needed to "push out" the cured bone cement from the molds was measured to determine the efficacy of each surface coating. Tukey's multiple comparison test was performed to compare the results of the pushout test. RESULTS: The average pushout force for the surface coatings, in increasing order, were as follows (mean ± standard deviation) --- bacitracin ointment: 9.10 ± 6.68 N, mineral oil: 104.93 ± 69.92 N, lubricating jelly: 147.76 ± 63.77 N, control group: 339.31 ± 305.20 N, ultrasound transmission gel 474.11 ± 94.77 N. Only the bacitracin ointment required significantly less pushout force than the control (p = 0.0123). CONCLUSIONS: The bacitracin ointment was the most effective surface coating, allowing the bone cement to be pushed out of the mold using the least amount of force. In addition, the low standard deviation speaks to the reliability of the bacitracin ointment to reduce mold adhesion compared to the other surface coatings. Given its efficacy as well as its ubiquitous presence in the hospital operating room setting, bacitracin ointment is an excellent choice to prevent adhesion between bone cement and 3D printed molds intraoperatively.

Accuracy of guide wire placement for femoral neck stabilization using 3D printed drill guides.

BACKGROUND: The goal of stabilization of the femoral neck is to limit morbidity and mortality from fracture. Of three potential methods of fixation, (three percutaneous screws, the Synthes Femoral Neck System, and a dynamic hip screw), each requires guide wire positioning of the implant(s) in the femoral neck and head. Consistent and accurate positioning of these systems is paramount to reduce surgical times, stabilize fractures effectively, and reduce complications. To help expedite surgery and achieve ideal implant positioning in the geriatric population, we have developed and validated a surgical planning methodology using 3D modelling and printing technology. METHODS: Using image processing software, 3D surgical models were generated placing guide wires in a virtual model of an osteoporotic proximal femur sawbone. Three unique drill guides were created to achieve the optimal position for implant placement for each of the three different implant systems, and the guides were 3D printed. Subsequently, a trauma fellowship trained orthopedic surgeon used the 3D printed guides to position 2.8 mm diameter drill bit tipped guide wires into five osteoporotic sawbones for each of the three systems (fifteen sawbones total). Computed Tomography (CT) scans were then taken of each of the sawbones with the implants in place. 3D model renderings of the CT scans were created using image processing techniques and the displacement and angular deviations at guide wire entry to the optimal sawbone model were measured. RESULTS: Across all three percutaneous screw guide wires, the average displacement was 3.19 ± 0.12 mm and the average angular deviation was 4.10 ± 0.17o. The Femoral Neck System guide wires had an average displacement of 1.59 ± 0.18 mm and average angular deviation of 2.81 ± 0.64o. The Dynamic Hip Screw had an average displacement of 1.03 ± 0.19 mm and average angular deviation of 2.59 ± 0.39o. CONCLUSION: The use of custom 3D printed drill guides to assist with the positioning of guide wires proved to be accurate for each of the three types of surgical strategies. Guides which are used to place more than 1 guide wire may have lower positional accuracy, as the guide may shift during multiple wire insertions. We believe that personalized point of care drill guides provide an accurate intraoperative method for positioning implants into the femoral neck.

Improving acetabular shell deformation testing.

BACKGROUND: To be FDA approved, acetabular shells must undergo rigorous testing. To prevent implant failure, acetabular shells must be able to tolerate peak loads during impaction with minimal deformation. The implants must therefore be validated in order to ensure that their structural integrity can tolerate peak loads. The current ISO 7206-12 recommends manufacturing an expensive single-purpose testing device to measure the deformation of acetabular shells. In the article, we provide an open access methodology, that can be conducted with minimal expense, for testing acetabular shell deformation. METHODS: We designed our experimental setup to utilize a servohydraulic materials testing device (Instron) commonly found in biomechanics laboratories and then validated the measurements optically with optical data. Furthermore, we designed an inexpensive acetabular screw fastener which acts as an adaptor that can be used to mount a variety of acetabular shell types just as effectively as current methods and is in compliance with the standards outlined in ISO 7206-12:2016. RESULTS: A Bland-Altman plot comparing the Instron and optical displacement measurements found the standard deviation of bias to be 0.046 mm and an insignificant systemic bias. CONCLUSION: We have developed and validated a low-cost open-source system that can effectively test acetabular shell deformation that meets ISO standards.

Mini-Blade Plate to Obtain Length Across Lateral Malleolus Fractures: Surgical Technique and Biomechanical Evaluation.

Background: Restoration of fibular length is the main determinant in preventing mal-union and early ankle arthritis in lateral malleolus fractures. A 1/3 tubular plate fashioned into a mini-blade plate can be used to distract the distal fragment and achieve length in a controlled fashion over time. The purpose of this study was to describe the surgical technique and perform a biomechanical comparison of the blade plate to a locking plate. Methods: A 1/3 tubular plate is fashioned into a 135° blade plate. Blades are seated into the lateral malleolus and a distally directed force is applied on the plate to obtain length.A lateral malleolus fracture was created in 20 cadaveric ankles. The distal fragment was fixed with either a blade plate (BP, n = 10) or a locking plate (LP, n = 10). A distally directed force was applied by an Instron machine and fracture distraction, maximal load and construct stiffness were measured and compared. Results: The average maximal load was 262.06 N compared to 255.52 N for the BP and LP groups, respectively. The maximal distraction was 3.57 mm compared to 4.57 mm for the BP and LP groups, respectively. The loading pattern of the blade plate over time differed from that of a locking plate as the blades seat into bone. Conclusion: A 1/3 tubular mini-blade plate demonstrates biomechanical similarities in terms of load and distraction to the more expensive locking plate. We recommend using this technique for fractures with late presentation or with significant shortening. Level of Evidence: Level V-Mechanism-based reasoning.

Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.

3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.