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.

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.

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.

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.

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.

Does generalized joint hypermobility influence the Ponseti treatment of clubfoot patients?

Previous investigators have suggested a role for generalized joint hypermobility (GJH) in the etiology of clubfoot deformity, while others have suggested its presence may influence treatment outcomes. We sought to determine if GJH was associated with the demographics, treatment, or propensity to relapse of patients whose clubfeet were managed using the Ponseti method. Fifty-seven patients with Ponseti-treated clubfeet comprised the cohort; median age 61 months (range, 38-111 months). A physical therapist evaluated each patient using the nine-point Beighton scale to quantify hypermobility. The scores were then correlated with patient sex, laterality, Dimeglio severity score, treatment, relapse, and surgery. The median Beighton score was 5; 49 of 57 patients (86%) had Beighton scores ≥4. All feet were plantigrade without symptomatic overcorrection at the time of evaluation. Although there was a slightly lower probability of relapse in patients with higher Beighton scores, this was not statistically significant (P = 0.10). Accordingly, the sex, laterality, initial severity, number of pretenotomy casts, need for tenotomy, relapse, and need for tendon transfer surgery were not significantly influenced by the Beighton score. The outcome of Ponseti clubfoot treatment is not altered by the presence of GJH in young children. Joint hypermobility does not appear to influence the likelihood of relapse or surgery. Unlike clubfeet reportedly treated with release surgery, Ponseti-treated clubfeet were not prone to excessive overcorrection regardless of joint laxity. Last, the distribution of Beighton scores in the study's cohort supports an association between GJH and clubfoot deformity.

Is load control necessary to produce physiological AP displacement and axial rotation in wear testing of TAR?

The International Standard Organization, ISO 22622, specifies two options for joint wear simulator evaluation of total ankle replacements (TARs): load-controlled and displacement-controlled. In the present study, the load-controlled testing parameters were applied to cadaveric specimens to quantify and compare the observed sagittal translations and axial rotations to those specified under the displacement-controlled option. Twelve cadaveric specimens were stripped of extraneous tissues, keeping surrounding ankle ligaments. A halo was used to produce plantarflexion and dorsiflexion of the talus through two screws, while a baseplate resisted axial loads. The axial force and torque were applied to the tibia and fibula under force and torque feedback control. An anterior-posterior force was applied to the tibia. Plantarflexion-dorsiflexion were applied using rotation control. To protect the cadaveric specimens, loads were applied at 50% of the specified load profile while plantarflexion-dorsiflexion rotation was applied as specified. There was variation among specimens in magnitudes of anterior-posterior displacement with peaks ranging from 3.3 mm posteriorly to 3.0 mm anteriorly. Likewise, there was variation among specimens in magnitude of axial rotation, with peaks ranging from 11° external rotation to 4.5° internal rotation. However, the mean magnitudes of AP displacement and axial rotation did not exceed those specified by ISO 22622.

A Systematic Review of Unsystematic Total Ankle Replacement Wear Evaluations.

BACKGROUND: Numerous studies have reported the use of laboratory multistation joint simulators to successfully predict wear performance and functionality of hip and knee replacements. In contrast, few studies in the peer-reviewed literature have used joint simulation to quantify the wear performance and functionality of ankle replacements. We performed a systematic review of the literature on joint simulator studies that quantified polyethylene wear in total ankle arthroplasty. In addition to the quantified wear results, the load and motion parameters were identified and compared among the studies. METHODS: A search was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to identify articles reporting total ankle replacement polyethylene wear using joint simulators. RESULTS: Nine studies that used joint simulators and 1 study that used a computer simulation were found. Although all studies used physiological multidirectional motions (i.e., internal/external rotation, plantar flexion/dorsiflexion, anterior/posterior translation), there was large variability among the studies in the magnitudes of these motions. Among these studies, mean non-cross-linked polyethylene wear ranged from 3.3 ± 0.4 to 25.8 ± 3.1 mm per million cycles. In contrast, mean highly cross-linked polyethylene wear ranged from 2.1 ± 0.3 to 3.3 ± 0.4 mm per million cycles. The wide distribution in wear rates was attributable to the highly inconsistent kinematic parameters and loads applied as well as differences in implant design and materials. CONCLUSIONS: There is a severe lack of clinically applicable data on wear performance of total ankle replacements in the peer-reviewed literature. No universal set of kinematic load parameters has been established. Furthermore, only 2 of the published studies have validated their findings using independently derived data, such as retrieval analysis. These shortcomings make it difficult to compare findings as a function of design parameters and materials, or to draw clinically relevant conclusions from these simulations. More work is required to enhance the predictive capability of in vitro simulations of total ankle replacements. CLINICAL RELEVANCE: The results of joint wear simulator studies may not accurately represent in vivo wear of total ankle replacements. Joint simulator studies should establish that they are accurately replicating in vivo wear, thus enabling use of their predictive capabilities for new materials and designs.

Increasing loads and diminishing returns: a biomechanical study of direct vertebral rotation.

STUDY DESIGN: Biomechanical simulation of DVR and pure-moment testing on thoracic spines. OBJECTIVES: Characterize load-deformation response of thoracic spines under DVR maneuvers until failure, and compare to pure-moment testing of same spines. Despite reports of surgical complications, few studies exist on increase in ROM under DVR torque. Biomechanical models predicting increases from surgical releases have consistently used "pure-moments", a standard established for non-destructive measurement of ROM. Yet, DVR torque is not accurately modeled using pure moments and, moreover, magnitudes of torque applied during DVR maneuvers may be substantially higher than pure-moment testing. METHODS: Cadaveric thoracic spines (N = 11) were imaged, then prepared. Polyaxial pedicle screws were implanted at T7-T10 after surgical releases. Bilateral facetectomies and Ponte osteotomies were completed at T10-T11. A custom apparatus, mounted into an 8-dof MTS load frame, was used to attach to pedicle screws, allowing simulation of surgical DVR maneuvers. Motions of vertebrae were measured using optical motion tracking. Torque was increased until rupture of the T10-T11 disc or fracture at the pedicle screw sites at any level. The torque-rotation behavior was compared to its behavior under pure-moment testing performed prior to the DVR maneuver. RESULTS: Under DVR maneuvers, failure of the T10-T11 discs accompanied in most cases by pedicle screw loosening, occurred at 13.7-54.7 Nm torque, increasing axial rotation by 1.4°-8.9°. In contrast, pure-moment testing (4 Nm) increased axial rotation by only 0.0°-0.9°. CONCLUSIONS: DVR resulted in substantially greater correction potential increases compared to pure-moment testing even at the same torque. These results suggest increased flexibility obtained by osteotomies and facetectomies is underestimated using pure-moment testing, misrepresenting clinical expectations. The present study is an important and necessary step toward the establishment of a more accurate and ultimately surgically applied model. LEVEL OF EVIDENCE: III.

Preclinical biomechanical testing models for the tibiotalar joint and its replacements: A systematic review.

In recent years, total ankle replacements have gained increasing popularity as an alternative to fusion. Preclinical testing of TARs requires reliable in vitro models which, in turn, need thorough knowledge of the kinematics of the tibiotalar joint. Surprisingly few studies have been published to simulate the in vivo kinematics of the tibiotalar joint. Among these studies, there is a wide range of methods and magnitudes of applied loads. The purpose of the present review was to summarize the applied loads, positions that were tested during static simulations, and ranges of motion simulated that have been used in human cadaveric models of the tibiotalar joint. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, PubMed and Google Scholar were searched for studies pertaining to cadaveric tibiotalar joint kinematics. Our search yielded 12 appropriate articles that were included in the systematic review. While it is well known that loads at the tibiotalar joint are frequently as high as 5 times bodyweight [1], these studies reported applied loads varying from 200N-750N, below average bodyweight. Three studies used dynamic loading of custom apparatuses to drive cadaver limbs along predetermined paths to simulate gait. Conversely, the other nine studies applied static loads (∼300N), performed at discreet points during the stance phase, considerably lower than physiological conditions. The present systematic review calls for an urgent need to establish a consensus for preclinical evaluation of TARs for biomechanical function.

Relapse Rates in Patients with Clubfoot Treated Using the Ponseti Method Increase with Time: A Systematic Review.

BACKGROUND: The Ponseti method is the preferred technique to manage idiopathic clubfoot deformity; however, there is no consensus on the expected relapse rate or the percentage of patients who will ultimately require a corrective surgical procedure. The objective of the present systematic review was to determine how reported rates of relapsed deformity and rates of a secondary surgical procedure are influenced by each study's length of follow-up. METHODS: A comprehensive literature search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was performed to identify relevant articles. The definition of relapse, the percentage of patients who relapsed, the percentage of feet that required a surgical procedure, and the mean duration of follow-up of each study were extracted. Pearson correlations were performed to determine associations among the following variables: mean follow-up duration, percentage of patients who relapsed, percentage of feet that required a joint-sparing surgical procedure, and percentage of feet that required a joint-invasive surgical procedure. Logarithmic curve fit regressions were used to model the relapse rate, the rate of joint-sparing surgical procedures, and the rate of joint-invasive surgical procedures as a function of follow-up time. RESULTS: Forty-six studies met the inclusion criteria. Four distinct definitions of relapse were identified. The reported relapse rates varied from 3.7% to 67.3% of patients. The mean duration of follow-up was strongly correlated with the relapse rate (Pearson correlation coefficient = 0.44; p < 0.01) and the percentage of feet that required a joint-sparing surgical procedure (Pearson correlation coefficient = 0.59; p < 0.01). Studies with longer follow-up showed significantly larger percentages of relapse and joint-sparing surgical procedures than studies with shorter follow-up (p < 0.05). CONCLUSIONS: Relapses have been reported to occur at as late as 10 years of age; however, very few studies follow patients for at least 8 years. Notwithstanding that, the results indicated that the rate of relapse and percentage of feet requiring a joint-sparing surgical procedure increased as the duration of follow-up increased. Longer-term follow-up studies are required to accurately predict the ultimate risk of relapsed deformity. Patients and their parents should be aware of the possibility of relapse during middle and late childhood, and, thus, follow-up of these patients until skeletal maturity may be warranted. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Biomechanical comparison of fixation stability using a Lisfranc plate versus transarticular screws.

BACKGROUND: To obtain adequate fixation in treating Lisfranc soft tissue injuries, the joint is commonly stabilized using multiple transarticular screws; however iatrogenic injury is a concern. Alternatively, two parallel, longitudinally placed plates, can be used to stabilize the 1st and 2nd tarsometatarsal joints; however this may not provide adequate stability along the Lisfranc ligament. Several biomechanical studies have compared earlier methods of fixation using plates to the standard transarticular screw fixation method, highlighting the potential issue of transverse stability using plates. A novel dorsal plate is introduced, intended to provide transverse and longitudinal stability, without injury to the articular cartilage. METHODS: A biomechanical cadaver model was developed to compare the fixation stability of a novel Lisfranc plate to that of traditional fixation, using transarticular screws. Thirteen pairs of cadaveric specimens were tested intact, after a simulated Lisfranc injury, and then following implant fixation, using one method of fixation randomly assigned, on either side of each pair. Optical motion tracking was used to measure the motion between each of the following four bones: 1st metatarsal, 2nd metatarsal, 1st cuneiform, and 2nd cuneiform. Testing included both cyclic abduction loading and cyclic axial loading. RESULTS: Both the Lisfranc plate and screw fixation method provided stability such that the average 3D motions across the Lisfranc joint (between 2nd metatarsal and 1st cuneiform), were between 0.2 and 0.4mm under cyclic abduction loading, and between 0.4 and 0.5mm under cyclic axial loading. Comparing the stability of fixation between the Lisfranc plate and the screws, the differences in motion were all 0.3mm or lower, with no clinically significant differences (p>0.16). CONCLUSIONS: Diastasis at the Lisfranc joint following fixation with a novel plate or transarticular screw fixation were comparable. Therefore, the Lisfranc plate may provide adequate support without risk of iatrogenic injury to the articular cartilage.

Sixty Years On: Ponseti Method for Clubfoot Treatment Produces High Satisfaction Despite Inherent Tendency to Relapse.

BACKGROUND: Developed at the University of Iowa in 1950, the Ponseti method to manage idiopathic clubfoot deformity was slow to gain wide acceptance until the mid-1990s. There is a paucity of intermediate and long-term outcome studies involving this technique, with nearly all such studies coming from a single institution. The purpose of this study is to report the contemporary outcome of patients with clubfoot deformity whose feet were managed with the Ponseti method and who were followed to ≥5 years old, to provide outcome expectations for parents and for clinicians managing patients with idiopathic clubfoot. METHODS: Families of infants seen in our clinic diagnosed with idiopathic clubfoot since July 2006 were prospectively invited to participate in our institutional review board-approved study. Patients who received no prior outside treatment and had a minimum follow-up to the age of 5 years were included. Demographic, treatment, and outcome data were collected. To provide an array of outcome measures, both the Dallas outcome criteria and the Roye disease-specific instrument (DSI) were used. RESULTS: One hundred and one patients met the inclusion criteria. The mean length of follow-up (and standard deviation) was 81.1 ± 17.1 months. Initial correction was achieved in all feet. Thirty-seven percent of families reported that they were adherent with the bracing protocol; 68% of patients had ≥1 relapse, and 38% underwent a tendon transfer. With the Dallas criteria, 62% had outcomes rated as good, 38% had outcomes rated as fair, and no patient had an outcome rated as poor. With the Roye DSI, most families were generally very satisfied with the function and appearance of the feet. CONCLUSIONS: Satisfactory results at intermediate follow-up were achieved using the Ponseti method. However, despite a better understanding of the Ponseti method and the importance of longer post-corrective brace use, the need for anterior tibial tendon transfer remains an important adjunct to the Ponseti method. Brace adherence also continues to be a critical clinical issue. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

How Many Patients Who Have a Clubfoot Treated Using the Ponseti Method are Likely to Undergo a Tendon Transfer?

BACKGROUND: The Ponseti method has become the standard of care for the treatment of idiopathic clubfoot. A commonly reported problem encountered with this technique is a relapsed deformity that is sometimes treated in patients older than 2.5 years by an anterior tibial tendon transfer (ATTT) to the third cuneiform. Presently, there is insufficient information to properly counsel families whose infants are beginning Ponseti treatment on the probability of needing later tendon transfer surgery. METHODS: All idiopathic clubfoot patients seen at the authors' institution during the study period who met the inclusion criteria and who were followed for >2.5 years were included (N=137 patients). Kaplan-Meier Survival analysis was used to determine the probability of survival without the need for ATTT surgery. In addition, the influence of patient characteristics, socioeconomic variables, and treatment variables on need for surgery was calculated. RESULTS: On the basis of the survivorship analysis, the probability of undergoing an ATTT remained below 5% for all patients at 3 years of age, but exceeded 15% by 4 years of age, increasing steadily afterwards such that by 6 years of age, the probability of undergoing an ATTT reached 29% of all patients. Overall, controlling for all other variables in the analysis, parent-reported adherence with bracing reduced the odds of undergoing surgery by 6.88 times, compared with parent-reported nonadherence (P<0.01). CONCLUSIONS: This is the first study to report the probability of undergoing ATTT surgery as a function of age using survivorship analysis following Ponseti clubfoot treatment. Although the overall probability reached 29% at 6 years, this was significantly reduced by compliance with bracing. This information may be useful to the clinician when counseling families at the start of treatment. LEVEL OF EVIDENCE: Level III-theraputic.