An additively manufactured model for preclinical testing of cervical devices.

Purpose: Composite models have become commonplace for the assessment of fixation and stability of total joint replacements; however, there are no comparable models for the cervical spine to evaluate fixation. The goal of this study was to create the framework for a tunable non-homogeneous model of cervical vertebral body by identifying the relationships between strength, in-fill density, and lattice structure and creating a final architectural framework for specific strengths to be applied to the model. Methods: The range of material properties for cervical spine were identified from literature. Using additive manufacturing software, rectangular prints with three lattice structures, gyroid, triangle, zig-zag, and a range of in-fill densities were 3D-printed. The compressive and shear strengths for all combinations were calculated in the axial and coronal planes. Eleven unique vertebral regions were selected to represent the distribution of density. Each bone density was converted to strength and subsequently correlated to the lattice structure and in-fill density with the desired material properties. Finally, a complete cervical vertebra model was 3D-printed to ensure sufficient print quality. Results: Materials testing identified a relationship between in-fill densities and strength for all lattice structures. The axial compressive strength of the gyroid specimens ranged from 1.5 MPa at 10% infill to 31.3 MPa at 100% infill and the triangle structure ranged from 2.7 MPa at 10% infill to 58.4 MPa at 100% infill. Based on these results, a cervical vertebra model was created utilizing cervical cancellous strength values and the corresponding in-fill density and lattice structure combination. This model was then printed with 11 different in-fill densities ranging from 33% gyroid to 84% triangle to ensure successful integration of the non-homogeneous in-fill densities and lattice structures. Conclusions: The findings from this study introduced a framework for using additive manufacturing to create a tunable, customizable biomimetic model of a cervical vertebra.

Comparison of a 2.7-mm and 3.5-mm locking compression plate for ulnar fractures: a biomechanical evaluation.

Objectives: Implant prominence after ulnar fracture fixation may be mitigated by the use of lower profile plates. The biomechanical strength and stability of 2.7-mm and 3.5-mm locking compression plates for fixation were compared. Methods: Two fracture conditions, transverse (N = 10) and oblique (N = 10), were evaluated in an in vitro study. Half of the specimens for each condition were fixed with 2.7-mm plates and the other half with 3.5-mm plates, all fixed with conventional dynamic compression mechanisms. Specimens were loaded under ±2 Nm of cyclic axial torsion, then under 10 Nm of cyclic cantilever bending, and bending to failure. Interfragmentary motion and strain were analyzed to determine construct stability as a function of fracture pattern and plate size. Results: Interfragmentary motion was significantly larger in all constructs fixed with 2.7-mm plates, compared with 3.5-mm plates (P < 0.01). The 2.7-mm constructs with transverse fractures had the greatest motion, ranging between 5° and 10° under axial rotation and 5.0-6.0 mm under bending. Motions were the lowest for 3.5-mm constructs with oblique fractures, ranging between 3.2 and 4.2 mm under bending and 2°-3.5° for axial rotation. For oblique fractures, the bending moment at ultimate failure was 31.4 ± 3.6 Nm for the 2.7-mm constructs and 10.0 ± 1.9 Nm for 3.5-mm constructs (P < 0.01). Similarly, for transverse fractures, the bending moment was 17.9 ± 4.0 Nm for the 2.7-mm constructs and 9.7 ± 1.3 Nm for the 3.5-mm constructs (P < 0.01). Conclusions: Although 3.5-mm plates were more effective at reducing fracture motion, they were consistently associated with refracture at the distal-most screw hole under load to failure. By contrast, 2.7-mm plates plastically deformed despite excessive loads, potentially avoiding a subsequent fracture. Level of Evidence: Level V.

Observations of bony ongrowth and clinical fixation in two retrieved disc replacements.

Total disc replacements utilize textured coatings to maximize bony ongrowth. However, the contribution of direct bony attachment to overall fixation for total disc replacements has not been reported. The goal of the present study was to document the extent of bony attachment to the surfaces of two clinically functional total disc replacements that were securely fixed at the time of revision. Two metal-and-polymeric disc replacements, one cervical and one lumbar, were evaluated following surgical retrieval. The cervical device was retrieved at 8 months and the lumbar device at 28 months post-operative. Both devices were reported well-fixed at the time of removal, with large bone masses attached to one endplate of each device. Visual inspections, non-destructive gravimetric measurements, and surface metrology were performed to assess fixation. These inspections suggested that both devices had been fixed at the time of removal with little in vivo mechanical damage, as surgical extraction damage was noted on both devices and provided imaging showed a lack of device migration. Devices were then embedded and sectioned to evaluate the bone-implant interface. High resolution photographs and contact microradiographs were taken to assess bony attachment. In contrast to initial analysis, these images revealed radiolucent gaps between the endplates and bone masses. Little direct contact between the bone and endplate surface was identified and the original surgical cuts were still visible. Both devices were clinically fixed at the time of removal and neither had complications associated with loosening. However, osseointegration was minimal in one of the devices and altogether absent from the other. The findings of the present study suggest that other factors may influence overall clinical fixation such as the surgical preparation of the vertebral bone or the surface roughness of the treated endplates. Despite the limitations of the present study, this information is unique to the current total disc replacement literature and the ongrowth and fixation of devices should be considered as a topic for future investigation.

Can severity of trunnion damage be estimated by visual inspection alone?

Taper corrosion has been widely reported to be problematic for modular total hip arthroplasty implants. A simple and systematic method to evaluate taper damage with sufficient resolution is needed. We introduce a semiquantitative grading system for modular femoral tapers to characterize taper corrosion damage. After examining a unique collection of retrieved cobalt-chromium (CoCr) taper sleeves (n = 465) using the widely-used Goldberg system, we developed an expanded six-point visual grading system intended to characterize the severity, visible material loss, and absence of direct component contact due to corrosion. Female taper sleeve damage was evaluated by three blinded observers using the Goldberg scoring system and the expanded system. A subset (n = 85) was then re-evaluated following destructive cleaning, using both scoring systems. Material loss for this subset was quantified using metrology and correlated with both scoring systems. There was substantial agreement in grading among all three observers with uncleaned (n = 465) and with the subset of cleaned (n = 85) implants. The expanded scoring criteria provided a wider distribution of scores which ultimately correlated well with corrosion material loss. Cleaning changed the average scores marginally using the Goldberg criteria (p = 0.290); however, using the VGS, approximately 40% of the scores for all observers changed, increasing the average score from 4.24 to 4.35 (p = 0.002). There was a strong correlation between measured material loss and new grading scores. The expanded scoring criteria provided a wider distribution of scores which ultimately correlated well with corrosion material loss. This system provides potential advantages for assessing taper damage without requiring specialized imaging devices.

Evaluation of Topology Optimization Using 3D Printing for Bioresorbable Fusion Cages: A Biomechanical Study in a Porcine Model.

STUDY DESIGN: Preclinical biomechanical study of topology optimization versus standard ring design for bioresorbable poly-ε-caprolactone (PCL) cervical spine fusion cages delivering bone morphogenetic protein-2 (BMP-2) using a porcine model. OBJECTIVE: The aim was to evaluate range of motion (ROM) and bone fusion, as a function of topology optimization and BMP-2 delivery method. SUMMARY OF BACKGROUND DATA: 3D printing technology enables fabrication of topology-optimized cages using bioresorbable materials, offering several advantages including customization, and lower stiffness. Delivery of BMP-2 using topology optimization may enhance the quality of fusion. METHODS: Twenty-two 6-month-old pigs underwent anterior cervical discectomy fusion at one level using 3D printed PCL cages. Experimental groups (N=6 each) included: Group 1: ring design with surface adsorbed BMP-2, Group 2: topology-optimized rectangular design with surface adsorbed BMP-2, and Group 3: ring design with BMP-2 delivery via collagen sponge. Additional specimens, two of each design, were implanted without BMP-2, as controls. Complete cervical segments were harvested six months postoperatively. Nanocomputed tomography was performed to assess complete bony bridging. Pure moment biomechanical testing was conducted in all three planes, separately. Continuous 3D motions were recorded and analyzed. RESULTS: Three subjects suffered early surgical complications and were not evaluated. Overall, ROM for experimental specimens, regardless of design or BMP-2 delivery method, was comparable, with no clinically significant differences among groups. Among experimental specimens at the level of the fusion, ROM was <1.0° in flexion and extension, indicative of fusion, based on clinically applied criteria for fusion of <2 to 4°. Despite the measured biomechanical stability, using computed tomography evaluation, complete bony bridging was observed in 40% of the specimens in Group 1, 50% of Group 2, 100% of Group 3, and none of the control specimens. CONCLUSION: A topology-optimized PCL cage with BMP-2 is capable of resulting in an intervertebral fusion, similar to a conventional ring-based design of the same bioresorbable material.

Load Sharing in the Femur Using Strut Allografts: A Biomechanical Study.

Background: Femoral strut allografts are used in revision hip arthroplasty for management of bone loss associated with implant failure or periprosthetic fractures. They have also been used to treat unremitting thigh pain in well-fixed cementless femoral stems, to address the differential in structural stiffness between the stem and femoral shaft. Our study used an in vitro biomechanical model to measure the effect of placement of allografts on femoral strains, to determine their load-sharing capacity. Material and methods: Three rosette strain gauges were applied to the femoral surface of each of 6 cadaveric femurs, at the stem tip level on anterior, medial, and lateral cortices. After stem implantation, cortical strut allografts were applied to the lateral femoral shaft and secured with 4 Dall-Miles cables. A fourth gauge was placed on the midpoint of the allograft. Strains were recorded in the intact femur, then the implanted femur with and without the allograft under simulated physiologic loading in a load frame. Results: Reduction in distal femoral principal strains, between 12% and 59%, was seen in all cortices following placement of the allograft. Under axial loading, 30% of the strain in the lateral cortex was borne by the allograft. Greater reductions in strain, by as much as 59%, occurred under axial load and torque. Conclusion: The results of this biomechanical model indicate that by placement of an allograft, cortical strains can be reduced to levels approaching those in an intact femur, supporting this technique for treatment of unremitting thigh pain in well-fixed prostheses.

Taper Material Loss in Total Hip Replacements: Is It Affected by Joint Friction?

BACKGROUND: Metal debris and corrosion products generated from the taper junctions of modular joint replacements have been recognized as contributors to failure. Therefore, understanding the factors associated with increased taper wear and corrosion is fundamental to improving implant performance. METHODS: A cohort of 85 large-diameter metal-on-metal heads and cups retrieved at revision surgery, after 10 to 96 months of service, was evaluated. First, metrology was conducted to quantify head taper material loss and implant articular surface wear. Then, joint frictional moments for each retrieved head-and-cup pair were measured during 10 cycles of simulated physiological gait in a biomechanical model. Taper material loss was evaluated for correlations with frictional moments, articular wear, head diameter, head-cup clearance, and time in vivo. RESULTS: Peak resultant frictional moments ranged from 9.1 to 26.3 Nm, averaging 17.3 ± 2.7 Nm. Fretting and corrosion damage during in vivo service resulted in material loss from the head tapers ranging between 0.04 and 25.57 mm3, compared with combined head and cup articular wear of 0.80 to 351.75 mm3 in this cohort. Taper material loss was not correlated with higher frictional moments (R = -0.20 to 0.11, p = 0.07 to 0.81). Higher frictional moments from axial rotation were correlated with higher head and cup wear (R = 0.33, p < 0.01). The correlation between taper material loss and head diameter was weak and did not reach statistical significance (R = 0.20, p = 0.07). Taper material loss was not correlated with nominal head-cup clearance (R = 0.06, p = 0.6). Finally, taper material loss increased significantly over time (R = 0.34, p < 0.01). CONCLUSIONS: Despite serious concerns regarding trunnionosis, volumes of head taper wear were generally lower than those of articular surface wear. There was no statistical correlation between taper wear and frictional moments. Therefore, the results suggest that high friction in metal-on-metal implants does not contribute to higher material loss at the head taper, despite high bending moments. CLINICAL RELEVANCE: The amount of metal debris and corrosion products from taper junctions of the joint arthroplasties, widely recognized as an insidious cause of failure, was not correlated with joint frictional moments. Multiple factors affect taper wear: implant design, material, size, surface finish, and patient weight and activity level. However, in the present cohort, high friction of metal-on-metal total hip replacements likely did not contribute to increased volume of material loss at taper interfaces, despite increased moments at the locations of taper material loss.

The lexicon for periprosthetic bone loss versus osteolysis after cervical disc arthroplasty: a systematic review.

BACKGROUND: Periprosthetic bone loss is a common observation following arthroplasty. Recognizing and understanding the nature of bone loss is vital as it determines the subsequent performance of the device and the overall outcome. Despite its significance, the term "bone loss" is often misused to describe inflammatory osteolysis, a complication with vastly different clinical outcomes and treatment plans. Therefore, the goal of this review was to report major findings related to vertebral radiographic bone changes around cervical disc replacements, mitigate discrepancies in clinical reports by introducing uniform terminology to the field, and establish a precedence that can be used to identify the important nuances between these distinct complications. METHODS: A systematic review of the literature was conducted following PRISMA guidelines, using the keywords "cervical," "disc replacement," "osteolysis," "bone loss," "radiograph," and "complications." A total of 23 articles met the inclusion criteria with the majority being retrospective or case reports. RESULTS: Fourteen studies reported periprosthetic osteolysis in a total of 46 patients with onset ranging from 15-96 months after the index procedure. Reported causes included: metal hypersensitivity, infection, mechanical failure, and wear debris. Osteolysis was generally progressive and led to reoperation. Nine articles reported non-inflammatory bone loss in 527 patients (52.5%), typically within 3-6 months following implantation. The reported causes included: micromotion, stress shielding, and interrupted blood supply. With one exception, bone loss was reported to be non-progressive and had no effect on clinical outcome measures. CONCLUSIONS: Non-progressive, early onset bone loss is a common finding after CDA and typically does not affect the reported short-term pain scores or lead to early revision. By contrast, osteolysis was less common, presenting more than a year post-operative and often accompanied by additional complications, leading to revision surgery. A greater understanding of the clinical significance is limited by the lack of long-term studies, inconsistent terminology, and infrequent use of histology and explant analyses. Uniform reporting and adoption of consistent terminology can mitigate some of these limitations. Executing these actionable items is critical to assess device performance and the risk of revision. LEVEL OF EVIDENCE IV: Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

Cross-Sectional Areas and Volumes Occupied by Implants in Simulated Scaphoid Fractures.

PURPOSE: This study determined the volume of bone replaced by an implant at the proximal and distal poles of simulated scaphoid fractures. We also measured the cross-sectional area of the implant relative to the cross-sectional area of the scaphoid at 2 different simulated fracture locations. METHODS: Microcomputed tomograhy scans of 7 cadaveric scaphoids were used to create 3-dimensional models in which transverse proximal pole and midwaist fractures were simulated. The volume occupied by 5 commonly used implants and the cross-sectional area occupied at the surface of the fractures was measured using a computer modeling software. RESULTS: For simulated proximal pole fractures, the implants replaced 1.5%-7.4% of the fracture cross-sectional area and 1.2%-6.4% of the proximal fragment bone volume. For midwaist fractures, the implants replaced 1.5%-6.8% of the fracture cross-sectional area and 1.8%-4.6% of the proximal pole volume. Although the different implant designs replaced different areas and volumes, all these differences were small and below 4%. CONCLUSIONS: This study provides data that relate to one aspect of fracture healing, specifically, the surface area occupied by 5 different implants in proximal and midwaist scaphoid fractures as well as the volume of bone replaced by the implant. CLINICAL RELEVANCE: As opposed to the impression provided by 2-dimensional planar imaging, when studied using a 3-dimensional model, the volume and surface area replaced by an implant represent a minimal percentage of scaphoid bone, suggesting a negligible clinical effect.

The insidious risk of periprosthetic fracture in clinically functional total hip arthroplasties: A biomechanical study of willed joints.

Femoral bone quality is a major risk factor of periprosthetic fracture after total hip arthroplasty (THA), which has mortality similar to native hip fractures but higher short-term morbidity. The goal of this study was to quantify cortical strains at the site of expected Vancouver Type-B periprosthetic fracture as a function of bone mineral density, femoral stem material, and fixation method using a series of 29 autopsy-retrieved, clinically asymptomatic hip joints with THA. Periprosthetic bone mineral content and density was assessed using dual-energy X-ray absorptiometry by Gruen Zone. Specimens then underwent combined cyclic axial and torsional loading, increasing incrementally from 100 N and ±1 Nm to peaks of 700 N and ±5 Nm. All specimens experienced significantly higher strains on the lateral surface than on the anterior surface, indicating that the bending loads in the frontal plane, rather than axial/torsional loads, had the predominant effect. Multiple significant relationships (p = 0.04, p = 0.02) were found between predicted periprosthetic strains calculated from radiographic measurements and observed principal strains. Though THA in the present study were in successful clinical service, the produced results indicated that some femurs with rigid cemented or noncemented implants were potentially at high risk for Vancouver Type-B fractures, which may be predicted radiographically.

Semi-quantitative histology confirms that the macrophage is the predominant cell type in metal-on-metal hip tissues.

Numerous studies have examined the histology of metal-on-metal hip tissues for evidence of a dose response to metal wear but have often reported inconclusive or contradictory findings. The aim of the present study was to address these discrepancies using multiple histological scoring methods to characterize the tissue features of one large group of revised metal-on-metal total hips. Periprosthetic tissues from 165 metal-on-metal hip revisions were examined for features of aseptic lymphocytic vasculitis associated lesions (ALVAL) as rated using two scoring systems as well as rankings for macrophage and lymphocyte numbers, intracellular wear debris and necrosis. Correlations between histological features and clinical variables including gender and time to revision and implant variables including articular surface wear volume or visual taper corrosion scores were examined. Both ALVAL scores reflected the macrophage dominated histology with average scores of 5.9/10 and 1.5/3. There was a statistically significant correlation between the original ALVAL score and wear rate per year (correlation coefficient = 0.17, p = .05) and a moderate correlation between the number of macrophages and wear particles and wear volume. There was no statistically significant correlation between wear and any other feature including lymphocytic inflammation or necrosis. Strong correlations between combined cup and ball wear volume and histological characteristics were not observed, although the number of macrophages was more closely correlated with wear than lymphocytes or necrosis.

A novel intramedullary nail to control interfragmentary motion in diaphyseal tibial fractures.

Numerous animal and human studies have demonstrated the benefit of controlled interfragmentary motion on fracture healing. In this study, we quantified interfragmentary motion and load transfer in tibial fractures fixed using a novel intramedullary nail (IMN) that allows controlled axial motion. Fifty composite tibias with various fracture patterns were utilized. For all test conditions, two interlocking screws were used to fix the nail in the proximal metaphysis, and two interlocking screws through the distal metaphysis. The nail allowed either no motion (static mode) or 1 mm (dynamic mode) of cyclic axial motion between the two fracture fragments for every fracture pattern tested. As expected, strain shielding was more prominent under static nail conditions. In contrast, specimens tested under dynamic nail conditions transferred axial load between the fracture fragments such that strains near the fracture site were generally similar to those measured on an intact tibia. Maximum shear strains proximal to the fracture were significantly lower in specimens with oblique or butterfly fracture patterns (p < 0.01) compared to intact specimens. This decrease in shear strain indicates that strain shielding effects were likely present due to the implant. However, strain shielding appeared to be reduced in tensile and compressive principal strains. In summary, the novel IMN allowed controlled axial motion between the fragments in a variety of common diaphyseal tibial fracture patterns. Clinical Significance: The present in vitro biomechanical study investigated a novel intramedullary nail capable of controlled axial interfragmentary motion which may potentially enhance fracture healing.

Objective analysis of intermediate-term outcome of the Ponseti technique: a review of the experience from Los Angeles.

The Ponseti method of manipulative treatment for clubfoot deformity became widely adopted by pediatric orthopaedic surgeons beginning in the mid-1990s. The technique allows correction of most idiopathic clubfeet using gentle manipulation and cast application. The treatment represents a marked advance over past efforts to gain correction of the foot through extensive release surgery. In 2006, we began a Clubfoot Clinic at the Orthopaedic Institute for Children in Los Angeles, California dedicated to managing clubfoot patients using Ponseti's method. An IRB-approved database of patient-related, treatment related, and demographic variables was assembled and used to ascertain the outcome of treatment as well as to address parental questions regarding certain aspects of treatment. Here, we present a review of our body of work, which has improved clinical decision making as well as our ability to better inform our patients' parents regarding the treatment and prognosis of the Ponseti method. Studies from our institution showed that while relapses and the need for extra-articular tibialis anterior tendon transfer (TATT) surgery remain common to the Ponseti method, these events do not adversely affect overall patient function or satisfaction. These findings were not unlike those of classic studies reported from Ponseti's institution. We conclude that the Ponseti method is not only a technique to achieve initial correction of an idiopathic clubfoot, but also how to manage relapses that will inevitably occur in many patients. While relapses and tendon transfer surgery are likely to remain common with this treatment method, these events do not adversely affect overall patient function or satisfaction. The parents of infants whose clubfeet are managed using the Ponseti method should be counselled accordingly.

Quantification of Ankle Dorsiflexion in Ponseti-managed Unilateral Clubfoot Patients During Early Childhood.

BACKGROUND: Following the initial correction of a clubfoot using the Ponseti method, diminished passive ankle dorsiflexion may be observed over time, which could represent a possible relapsed deformity. Alternatively, the change may be attributable to patient age or other variables. Our purpose was to quantify passive ankle dorsiflexion in the involved and contralateral unaffected limbs of Ponseti-managed unilateral clubfoot patients, and to determine what patient-related variables influence this finding. METHODS: In total, 132 unilateral clubfoot patients were studied. Passive ankle dorsiflexion was measured in both limbs at each visit. Data were excluded from visits in which patients showed clear evidence of a relapse. Mean ankle dorsiflexion for clubfeet and contralateral unaffected limbs were reported for annual age intervals and compared using paired t tests. A general linear model was established to assess the effects of age, severity, sex, and side on ankle dorsiflexion. RESULTS: Mean ankle dorsiflexion for unaffected limbs declined with age, measuring 53±6 degrees between 0 and 1 year of age and decreasing to 39±7 degrees by 4 to 5 years of age. Similarly, mean ankle dorsiflexion in treated clubfeet declined with age, measuring 44±7 degrees between 0 and 1 year and 29±7 degrees between 4 and 5 years. Overall, the difference between limbs in these patients averaged ~10 degrees for every age interval through 9 years (P<0.001). Ankle dorsiflexion of clubfeet in 95% of patients aged 0 to 2 years was at least 20 degrees, and in 95% of patients aged 3 to 5 years this was at least 15 degrees. Patient age (P<0.001) and severity of deformity (P<0.001) were found to be the only significant factors affecting ankle dorsiflexion in the affected limbs. CONCLUSIONS: Ankle dorsiflexion in the Ponseti-treated clubfeet was influenced by age of the patient and the initial severity of the affected limb. Furthermore, our data suggest that, in patients who showed no relapse, a minimum of 20 degrees of ankle dorsiflexion in the corrected clubfoot is maintained through age 3 years and a minimum of 15 degrees is maintained through age 5 years. LEVEL OF EVIDENCE: Level IV-this is a retrospective case series.

Damage patterns in polyethylene fixed bearings of retrieved total ankle replacements.

INTRODUCTION: Poor long-term outcomes continue to hinder the universal adoption of total ankle replacements (TAR) for end stage arthritis. In the present study, polyethylene inserts of TARs retrieved at revision surgery were analyzed for burnishing, scratching, mechanical damage, pitting, and embedded particles. METHODS: Fourteen retrieved polyethylene inserts from a fixed bearing total ankle replacement design currently in clinical use were analyzed. Duration of time in vivo was between 11.5 months and 120.1 months. Three investigators independently graded each articular surface in quadrants for five features of damage: burnishing, scratching, mechanical damage, pitting, and embedded particles. RESULTS: No correlation was found for burnishing between the anterior and posterior aspects (p = 0.47); however, scratching and pitting were significantly higher on the posterior aspect compared to the anterior aspect (p < 0.03). There was a high correlation between burnishing and in vivo duration of the implant (anterior: R = 0.67, p = 0.01, posterior: R = 0.68, p = 0.01). CONCLUSION: The higher concentration of posterior damage on these polyethylene inserts suggested that prosthesis-related (design) or surgeon-related (technique) factors might restrict the articulation of the implant. The resulting higher stresses in the posterior articular surfaces may have contributed to the failure of retrieved implants Keywords: Retrieval, Polyethylene Damage, Total Ankle Replacement.