Three-Dimensional Printed Total Talus Replacement with a Concurrent Total Ankle Arthroplasty as a Personalized Approach for Advanced Ankle Osteoarthritis A Case Repor.

Ankle arthritis is becoming more common and can be pain-ful and debilitating. As the disease progresses, degenera-tive cystic changes may be found in the distal fibula, distal tibia, and talus. After failure of non-operative modalities, arthrodesis is often considered the surgical intervention of choice, but this leaves the patient with reduced range of motion, altered gait, and can negatively impact adjacent joints of the foot. Total ankle arthroplasty has been found to be an effective surgical option for ankle arthritis but is contraindicated in patients with talar collapse. When this is the case, a more personalized approach for preserving ankle motion is necessary. We present the case of a 65-year-old male with severe right ankle arthritis and talar collapse treated with a custom three-dimensionally printed talus and concurrent total ankle replacement with 2-year follow-up.

Assessment of bone ingrowth around beaded coated tibial implant for total ankle replacement using mechanoregulatory algorithm.

The long-term performance of porous coated tibial implants for total ankle replacement (TAR) primarily depends on the extent of bone ingrowth at the bone-implant interface. Although attempts were made for primary fixation for immediate post-operative stability, no investigation was conducted on secondary fixation. The aim of this study is to assess bone ingrowth around the porous beaded coated tibial implant for TAR using a mechanoregulatory algorithm. A realistic macroscale finite element (FE) model of the implanted tibia was developed based on computer tomography (CT) data to assess implant-bone micromotions and coupled with microscale FE models of the implant-bone interface to predict bone ingrowth around tibial implant for TAR. The macroscale FE model was subjected to three near physiological loading conditions to evaluate the site-specific implant-bone micromotion, which were then incorporated into the corresponding microscale model to mimic the near physiological loading conditions. Results of the study demonstrated that the implant experienced tangential micromotion ranged from 0 to 71 µm with a mean of 3.871 µm. Tissue differentiation results revealed that bone ingrowth across the implant ranged from 44 to 96 %, with a mean of around 70 %. The average Young's modulus of the inter-bead tissue layer varied from 1444 to 4180 MPa around the different regions of the implant. The analysis postulates that when peak micromotion touches 30 µm around different regions of the implant, it leads to pronounced fibrous tissues on the implant surface. The highest amount of bone ingrowth was observed in the central regions, and poor bone ingrowth was seen in the anterior parts of the implant, which indicate improper osseointegration around this region. This macro-micro mechanical FE framework can be extended to improve the implant design to enhance the bone ingrowth and in future to develop porous lattice-structured implants to predict and enhance osseointegration around the implant.

Early experience with a 3-D printed porous surface, fixed-bearing, total ankle arthroplasty: A minimum of 2-year follow-up.

BACKGROUND: This is a pilot study reviewing patients undergoing ankle replacement with the 3-D printed INFINITY™ with ADAPTIS™ total ankle arthroplasty (TAA) system. METHODS: A retrospective review was conducted of patients with a minimum two-year follow-up who underwent TAA with the INFINITY™ with ADAPTIS™ implant system. Outcome measures include implant survivorship, complications with subsequent reoperations, patient reported outcomes, and radiologic subsidence or radiolucency. RESULTS: Thirty patients were included with median follow-up of 26 months (range, 24-36). Implant survival rate was 90% (27/30). Two patients experienced linear radiolucency > 2 mm: one required a revision TAA secondary to tibial subsidence; the other patient was asymptomatic and nonprogressive on serial radiographs. No cystic radiolucencies > 5 mm were identified. VAS, PROMIS PF, and FADI scores improved significantly. CONCLUSION: TAA performed with the 3-D printed INFINITY™ with ADAPTIS™ implant technology led to ninety percent short term implant survivorship and improvement in patient reported outcomes with comparable results to other 4th generation arthroplasty systems as a treatment modality for end-stage ankle arthritis. LEVEL OF EVIDENCE: Level III, Retrospective cohort study, Prognostic.

Implant Choice May Reduce the Risk of Early Mechanical Failure in Total Ankle Replacement.

BACKGROUND: Total ankle replacements (TARs) have rapidly advanced in terms of volume, technique, design, and indications. However, TARs are still at risk for early mechanical failure and revision. Prior studies have investigated potential risk factors for failure, but have been limited to smaller series or older implants. This study sought to identify risk factors for early mechanical failure in modern TAR. METHODS: This is a retrospective study of a single-institution registry. Five surgeons contributed cases involving patients who underwent a primary TAR with any implant. Implants were grouped on the basis of the type of fixation. The primary outcome was early mechanical failure (revision with component removal for a non-infectious etiology, that is, subsidence, aseptic loosening, and/or malalignment). Logistic regression determined the effects of age, weight, hindfoot arthrodesis, implant type, and radiographic deformity on failure. RESULTS: The 731 included patients had a mean follow-up of 2.7 years. Ten percent (71 patients) had hindfoot arthrodesis. There were 33 mechanical failures (4.5%) at a mean of 1.7 years after the index surgical procedure. Our model demonstrated that hindfoot arthrodesis was associated with 2.7 times greater odds of failure (p = 0.045), every 10 kg of body weight increased the odds of tibial-sided failure by 1.29 times (p = 0.039), and implants with more extensive tibial fixation (stems or keels) lowered the odds of tibial failure by 95% (p = 0.031). CONCLUSIONS: In patients with uncontrollable risk factors (hindfoot arthrodesis) or risk factors that may or may not be modifiable by the patient (weight), implants with more robust tibial fixation may be able to reduce the risk of early mechanical failure. Further research is warranted to support efforts to decrease early failure in TAR. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Fixed-bearing versus mobile-bearing total ankle replacement survivorship. A meta-analysis.

BACKGROUND: Main objective of this research is to know if there is a different survival rate between fixed bearing (FB) and mobile bearing (MB) total ankle replacement (TAR). We hypothesized that there are no differences between the survival rates of both implants. METHODS: A systematic search was performed in PubMed, Cochrane, EMBASE and ClinicalTrials.gov databases to identify published studies from August 2018 to September 2022 including results for FB and MB TAR survivorship. Inclusion criteria included 1) primary TAR in one or both feet in which implant could be identified , 2) a minimum of 20 procedures reported, 3) reported implant survivorship or calculable and 4) a minimum of 12 months follow-up for level 1-3 studies or 60 months for level 4 studies. RESULTS: 3902 ankles in 28 studies were included. 719 were FB and 3104 MB with an overall survivorship of 94% (95% CI [0.89; 0.97]) and 89% (95% CI [0.86; 0.92]) respectively. After subgroup analysis, we did not find differences among both groups (p =  0.429 ). Meta-regression analysis showed that longer follow-up was associated with lower survival rates in MB group (p = 0.000) while no other relationships were found with other factors (age, level of evidence or conflict of interests). CONCLUSIONS: No differences in survival rates between both groups were found. Age and other studied confounders were not found to be related with implant survivorship. However, longer follow-up was found to be related with lower survival rates. Studies with longer follow-up and higher level of evidence are needed to confirm results. LEVEL OF EVIDENCE: IV, systematic review of level I to IV studies.

Influence of sidewall retention and interference fit in total ankle replacement on implant-bone micromotion: A finite element study.

The success of uncemented total ankle replacement (TAR) is linked to initial stability because bony ingrowth depends upon limited early micromotion. Tibial implant design fixation features resist micromotion aided by bony sidewall retention and interference fit. Our goal was to investigate factors influencing implant-bone micromotion in TAR. Two TAR tibial components were virtually inserted into CT-derived computer models of two distal tibias from patients with end-stage ankle arthritis. Density-based inhomogeneous material assignment was used to model bone compaction during press-fit. Finite element analysis (FEA) was used to simulate three fixation cases: (1) no sidewalls + line-to-line fit, (2) sidewalls + line-to-line fit, and (3) sidewalls + 50, 100, or 200 µm interference fit. Kinetic profiles from the stance phase of gait were simulated and micromotions computed from FEA output. Without sidewalls or interference fit, micromotions were largest in early and late stance, with largest micromotions (averaging ~150-250 µm) observed near heel strike. Micromotions decreased 39%-62% when sidewalls were retained. When interference fit was also modeled, micromotions decreased another 37%-61% to ~10 µm. Micromotion differences between patients persisted with sidewall retention but largely disappeared with interference fit. This study presents new insights into the effects of TAR fixation features on implant-bone micromotion. Stability appeared to be influenced by surrounding bone quality, but this influence was greatly diminished when interference fit was introduced. More complete understanding of TAR implant features and performance is needed, but our results show the importance of bone quality and interference fit in the stability of uncemented TAR.

A macro-micro FE and ANN framework to assess site-specific bone ingrowth around the porous beaded-coated implant: an example with BOX® tibial implant for total ankle replacement.

The use of mechanoregulatory schemes based on finite element (FE) analysis for the evaluation of bone ingrowth around porous surfaces is a viable approach but requires significant computational time and effort. The aim of this study is to develop a combined macro-micro FE and artificial neural network (ANN) framework for rapid and accurate prediction of the site-specific bone ingrowth around the porous beaded-coated tibial implant for total ankle replacement (TAR). A macroscale FE model of the implanted tibia was developed based on CT data. Subsequently, a microscale FE model of the implant-bone interface was created for performing bone ingrowth simulations using mechanoregulatory algorithms. An ANN was trained for rapid and accurate prediction of bone ingrowth. The results predicted by ANN are well comparable to FE-predicted results. Predicted site-specific bone ingrowth using ANN around the implant ranges from 43.04 to 98.24%, with a mean bone ingrowth of around 74.24%. Results suggested that the central region exhibited the highest bone ingrowth, which is also well corroborated with the recent explanted study on BOX®. The proposed methodology has the potential to simulate bone ingrowth rapidly and effectively at any given site over any implant surface.

Two-Year Outcomes After Total Ankle Replacement With a Novel Fixed-Bearing Implant By a Single Surgeon Non-Inventor.

Total ankle arthroplasty continues to gain popularity amongst surgeons and patients as an alternative to arthrodesis. Historically the designs of early implants were plagued with complications and frequently abandoned. Since that time the procedure and materials have undergone significant advancements in both surgical approach as well as design and function of the available implants. In this study, 40 consecutive patients who received a semiconstrained prosthesis with a unique fixed-bearing polyethylene insert were identified. Minimum follow-up was 2 y. Demographic, social, and past medical data was retrospectively reviewed. Concomitant procedures were also recorded. Radiographic analysis included lateral ankle radiograph postoperative range of motion (ROM) with maximum dorsiflexion and maximum plantarflexion weight bearing at the most recent clinic visit. Clinical outcomes included VAS, FFI, and AOFAS scores. Lateral radiographs taken in the office at a minimum 2-y follow-up showed mean maximum dorsiflexion of 11.8 degrees and plantarflexion of 13.9 degrees. VAS, FFI, and AOFAS scores improved from 8.1, 92.9, and 44.8 to 1.4, 15.3, and 90.1 postoperatively, respectively. A total of 2.5% (n = 1) required revision surgery for poly failure, and 5.0% (n = 2) underwent local wound care in the office setting postoperatively and healed without complications. Overall survivorship was 97.5% at the minimum follow-up of 2 y. In conclusion, similar studies have reported survivorship from 90% to 100% with modern ankle implants in short to mid-term follow-up. Although this is a small sample size, our data shows a 97.5% survivorship at 2 y postoperatively with favorable patient-reported statistically significant functional outcome scores, and ankle range of motion consistent with existing literature.

Patient-specific instrumentation (PSI) in total ankle arthroplasty: a systematic review.

BACKGROUND: Patient-specific instrument (PSI) may theoretically make total ankle arthroplasty (TAA) more accurate. Several studies have reported the outcomes of PSI TAA. The aim of this study is to systematically review the literature of PSI TAA. METHODS: PubMed, Embase, Web of Science, and Cochrane Library databases were systematically reviewed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines for PSI TAA. The quality of the included studies was evaluated according to Methodological Index for Non-Randomized Studies (MINORS). RESULT: Nine articles were ultimately included in the systematic review. The implant position and function outcome of TAA was similar between PSI and SI. Prediction accuracy of implant size remained great difference. PSI can shorten the operative time and fluoroscopy time. The quality of current studies on PSI TAA is insufficient to produce high-level evidence. CONCLUSION: PSI can get similar implant position and clinical outcome in TAA compared to SI, but current evidence is not strong enough to evaluate PSI TAA.

Three-Year Rates of Reoperation and Revision Following Mobile Versus Fixed-Bearing Total Ankle Arthroplasty: A Cohort of 302 Patients with 2 Implants of Similar Design.

BACKGROUND: Currently, the implants utilized in total ankle arthroplasty (TAA) are divided between mobile-bearing 3-component and fixed-bearing 2-component designs. The literature evaluating the influence of this mobility difference on implant survival is sparse. The purpose of the present study was therefore to compare the short-term survival of 2 implants of similar design from the same manufacturer, surgically implanted by the same surgeons, in fixed-bearing or mobile-bearing versions. METHODS: All patients were enrolled who underwent TAA with either the mobile-bearing Salto (Tornier and Integra) or the fixed-bearing Salto Talaris (Integra) in 3 centers by 2 surgeons between January 2004 and March 2018. All patients who underwent TAA from January 2004 to April 2013 received the Salto implant, and all patients who underwent TAA after November 2012 received the Salto Talaris implant. The primary outcome was time, within 3 years, to first all-cause reoperation, revision of any metal component, and revision of any component, including the polyethylene insert. Secondary outcomes included the frequency, cause, and type of reoperation. RESULTS: A total of 302 consecutive patients were included, of whom 171 received the mobile-bearing and 131 received the fixed-bearing implant. The adjusted hazard ratio for all-cause reoperation was 1.42 (95% confidence interval [CI], 0.67 to 3.00; p = 0.36); for component revision, 3.31 (95% CI, 0.93 to 11.79; p = 0.06); and for metal component revision, 2.78 (95% CI, 0.58 to 13.33; p = 0.20). A total of 31 reoperations were performed in the mobile-bearing group compared with 14 in the fixed-bearing group (p = 0.07). More extensive reoperation procedures were performed in the mobile-bearing group. CONCLUSIONS: With the largest comparison of 2 implants of similar design from the same manufacturer, the present study supports the use of a fixed-bearing design in terms of short-term failure. We found a 3-times higher rate of revision among mobile-bearing implants compared with fixed-bearing implants at 3 years after TAA. Reoperations, including first and subsequent procedures, tended to be less common and the causes and types of reoperations less extensive among fixed-bearing implants. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Early Joint Replacement in Juvenile Idiopathic Arthritis: Trend Over Time and Factors Influencing Implant Survival.

OBJECTIVE: To describe early prosthesis implantations in a cohort of patients with juvenile idiopathic arthritis (JIA) followed in a tertiary referral hospital and to analyze possible factors influencing implant survival. METHODS: This was a retrospective cohort study. Charts of all patients with JIA who underwent total joint replacement at Gaetano Pini Hospital, Milan, Italy from January 1992 to June 2019 were retrieved, and relevant data were analyzed. RESULTS: Eighty-five patients met the inclusion criteria for this study, with a median follow-up period of 17.2 years. The median age at first prosthesis was 22.7 years. The total number of replaced joints was 198 over a period of 27 years. The hip was the most frequently replaced joint, accounting for almost two-thirds of the total number of implants; the other one-third refers mostly to knee implants. Polyarticular JIA and systemic JIA were the most represented JIA categories in the study cohort. A significant upward trend of the age at arthroplasty and of disease duration before arthroplasty over decades was found. The rates of implant survival at 5, 10, and 15 years were comparable (from 84% to 89%); 50% of implants lasted ≥20 years. CONCLUSION: We reported retrospective data on early joint replacement in a cohort of patients with JIA. We observed a progressive and significant upward trend of both age at arthroplasty and disease duration before the first arthroplasty over time. The JIA category, year of implant, and presence of complications significantly affected implant survivorship.

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 new ligament-compatible patient-specific 3D-printed implant and instrumentation for total ankle arthroplasty: from biomechanical studies to clinical cases.

BACKGROUND: Computer navigation and patient-specific instrumentation for total ankle arthroplasty have still to demonstrate their theoretical ability to improve implant positioning and functional outcomes. The purpose of this paper is to present a new and complete total ankle arthroplasty customization process for severe posttraumatic ankle joint arthritis, consisting of patient-specific 3D-printed implant and instrumentation, starting from a ligament-compatible design. CASE PRESENTATION: The new customization process was proposed in a 57-year-old male patient and involved image analysis, joint modeling, prosthesis design, patient-specific implant and instrumentation development, relevant prototyping, manufacturing, and implantation. Images obtained from a CT scan were processed for a 3D model of the ankle, and the BOX ankle prosthesis (MatOrtho, UK) geometries were customized to best fit the model. Virtual in silico, i.e., at the computer, implantation was performed to optimize positioning of these components. Corresponding patient-specific cutting guides for bone preparation were designed. The obtained models were printed in ABS by additive manufacturing for a final check. Once the planning procedure was approved, the models were sent to final state-of-the-art additive manufacturing (the metal components using cobalt-chromium-molybdenum powders, and the guides using polyamide). The custom-made prosthesis was then implanted using the cutting guides. The design, manufacturing, and implantation procedures were completed successfully and consistently, and final dimensions and location for the implant corresponded with the preoperative plan. Immediate post-op X-rays showed good implant positioning and alignment. After 4 months, clinical scores and functional abilities were excellent. Gait analysis showed satisfactory joint moment at the ankle complex and muscle activation timing within normality. CONCLUSIONS: The complete customization process for total ankle arthroplasty provided accurate and reliable implant positioning, with satisfactory short-term clinical outcomes. However, further studies are needed to confirm the potential benefits of this complete customization process. LEVEL OF EVIDENCE: 5.

Radiographic and Clinical Outcomes of the Salto Talaris Total Ankle Arthroplasty.

BACKGROUND: The Salto Talaris is a fixed-bearing implant first approved in the US in 2006. While early surgical outcomes have been promising, mid- to long-term survivorship data are limited. The aim of this study was to present the survivorship and causes of failure of the Salto Talaris implant, with functional and radiographic outcomes. METHODS: Eighty-seven prospectively followed patients who underwent total ankle arthroplasty with the Salto Talaris between 2007 and 2015 at our institution were retrospectively identified. Of these, 82 patients (85 ankles) had a minimum follow-up of 5 (mean, 7.1; range, 5-12) years. The mean age was 63.5 (range, 42-82) years and the mean body mass index was 28.1 (range, 17.9-41.2) kg/m2. Survivorship was determined by incidence of revision, defined as removal/exchange of a metal component. Preoperative, immediate, and minimum 5-year postoperative AP and lateral weightbearing radiographs were reviewed; tibiotalar alignment (TTA) and the medial distal tibial angle (MDTA) were measured to assess coronal talar and tibial alignment, respectively. The sagittal tibial angle (STA) was measured; the talar inclination angle (TIA) was measured to evaluate for radiographic subsidence of the implant, defined as a change in TIA of 5 degrees or more from the immediately to the latest postoperative lateral radiograph. The locations of periprosthetic cysts were documented. Preoperative and minimum 5-year postoperative Foot and Ankle Outcome Score (FAOS) subscales were compared. RESULTS: Survivorship was 97.6% with 2 revisions. One patient underwent tibial and talar component revision for varus malalignment of the ankle; another underwent talar component revision for aseptic loosening and subsidence. The rate of other reoperations was 21.2% (n = 18), with the main reoperation being exostectomy with debridement for ankle impingement (n = 12). At final follow-up, the average TTA improved 4.4 (± 3.8) degrees, the average MDTA improved 3.4 (± 2.6) degrees, and the average STA improved 5.3 (± 4.5) degrees. Periprosthetic cysts were observed in 18 patients, and there was no radiographic subsidence. All FAOS subscales demonstrated significant improvement at final follow-up. CONCLUSIONS: We found the Salto Talaris implant to be durable, consistent with previous studies of shorter follow-up lengths. We observed significant improvement in radiographic alignment as well as patient-reported clinical outcomes at a minimum 5-year follow-up. LEVEL OF EVIDENCE: Level IV, retrospective case series.

A novel method to eliminate the influence of absorbed lipids on the characterization of ultra-high molecular weight polyethylene using Fourier-transform infrared spectroscopy.

BACKGROUND: Fourier-transform infrared spectroscopy (FTIR) is one of the standard methods to analyze ultra-high molecular weight polyethylene (UHMWPE) in orthopedic implants. For retrieved components, lipid extraction using an organic solvent prior to the measurement is necessary to eliminate the influence of lipids absorbed in vivo. However, its influence on the measurement has not been substantially investigated. OBJECTIVE: To investigate the influence of lipid extraction on the FTIR analysis of UHMWPE and to develop a novel method to obtain reliable results without inconvenient lipid extraction. METHODS: FTIR analysis was repeatedly performed on UHMWPE specimens from retrieved components before and after lipid extraction under various conditions. A method to calculate the extent of influence of the absorbed lipids from the FTIR spectra was developed using a peak separation technique. RESULTS: An elevated temperature was necessary for lipid extraction; however, it had the potential to influence the results if the conditions were not properly controlled. The results obtained using the peak separation technique coincided with those obtained after lipid extraction. CONCLUSION: The use of the peak separation technique enables the efficient acquisition of reliable results without the need for lipid extraction.

Three-dimensional morphological analysis and clinical application of ankle joint in Chinese population based on CT reconstruction.

PURPOSE: To study the anatomical features of the ankle joint in Chinese northeast healthy adults and provide accurate data for the design of the total ankle arthroplasty (TAA) prosthesis. METHODS: Computer tomography (CT) images from 156 healthy subjects, 86 males and 70 females, were collected and reconstructed through Mimics software. The 3D morphology of the distal tibia/fibula section and the whole talar was analyzed by measuring 28 parameters including maximal tibial thickness (MTiTh), anterior-posterior inclination angle, trochlea tali width (TaW), distal tibial width (TiW) and trochlea tali arc chode length (TaAL) and calculating MTiTh/TiW, TaAL/TaW. Gender difference and accuracy of CT images were evaluated. The measurements were compared with previously reported data from Caucasian subjects and Asian subjects. Statistical analysis was conducted by independent-samples t test through SPSS software. RESULTS: (1) Twenty two out of the 28 parameters were found significantly different between males and females. Most of the parameters in males were found larger than that in females (p < 0.05). (2) The difference was found larger in comparison with the Caucasian subject groups than that with Asian subject groups. (3) All the selected 11 parameters measured by CT images were found to be smaller than those by X-ray images (p < 0.05). CONCLUSION: The morphological parameters were found different between the Caucasian and Chinese northeast populations. Precise data of the ankle joint morphology were provided for the design and clinical application of TAA in the Chinese population.

Histological Analysis of a Retrieved Porous Tantalum Total Ankle Replacement: A Case Report.

CASE: We present a case report documenting the retrieval and histological analysis of a porous tantalum (P-Ta) total ankle replacement (TAR) from a 50-year-old woman after a below-knee transtibial amputation. This rare opportunity to examine an intact TAR may help to better understand the implant-bone relationship because it would be in situ. CONCLUSION: In this case study, we demonstrate bone ingrowth to the first layer of the P-Ta and organized trabecular orientation, suggesting that equal bone load was achieved on the base and the rails in both components using a transfibular surgical approach.

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.

Better implant survival with modern ankle prosthetic designs: 1,226 total ankle prostheses followed for up to 20 years in the Swedish Ankle Registry.

Background and purpose - We have previously reported on the prosthetic survival of total ankle replacements (TAR) in Sweden performed between 1993 and 2010. Few other reports have been published on 5- and 10-year survival rates. Furthermore, there is a lack of long-term outcome data on modern prosthetic designs. Therefore, we compared early and current prosthetic designs after a mean 7-year follow-up.Patients and methods - On December 31, 2016, 1,230 primary TARs had been reported to the Swedish Ankle Registry. We analyzed prosthetic survival, using exchange or permanent extraction of components as endpoint for 1,226 protheses with mean follow-up of 7 years (0-24). Differences between current (Hintegra, Mobility, CCI, Rebalance, and TM Ankle) and early prosthetic designs (STAR, BP, and AES) were examined by log rank test.Results - 267/1,226 prostheses (22%) had been revised by December 31, 2016. We found an overall prosthetic survival rate at 5 years of 0.85 (95% CI 0.83-0.87), at 10 years 0.74 (CI 0.70-0.77), at 15 years 0.63 (CI 0.58-0.67), and at 20 years 0.58 (CI 0.52-0.65). For early prosthetic designs the 5- and 10-year survival rates were 0.81 (CI 0.78-0.84) and 0.69 (CI 0.64-0.73) respectively, while the corresponding rates for current designs were 0.88 (CI 0.85-0.91) and 0.84 (CI 0.79-0.88). Current prosthetic designs had better survival (log rank test p < 0.001).Interpretation - Our results point to a positive time trend of prosthetic survival in Sweden; use of current prosthetic designs was associated with better prosthetic survival. Improved designs and instrumentation, more experienced surgeons, and improved patient selection may all have contributed to the better outcome.

Evaluation of Hindfoot Alignment After Fixed- and Mobile-Bearing Total Ankle Prostheses.

BACKGROUND: End-stage ankle arthritis can involve malalignment of the ankle in both the coronal and sagittal planes. Up to 33% to 44% of patients who present for total ankle replacement (TAR) have greater than 10° of coronal plane deformity. Normalization of the sagittal and coronal alignment is key in improving survivorship and functional outcomes in TAR. In the present study, we analyzed how both the ankle and hindfoot alignment for both a fixed-bearing and mobile-bearing TAR system changed over time. Specifically, we measured coronal and sagittal alignment of both the ankle and hindfoot complex. METHODS: A retrospective study was performed on 2 independent groups of patients undergoing 2 different systems for total ankle replacement: Zimmer (lateral approach, fixed-bearing) and Hintegra (anterior approach, mobile bearing). Specific demographic data and radiographic data were measured. Within-group comparisons were performed using 1-way repeated measures ANOVA, analyzing the temporal course of clinical data within the Hintegra and Zimmer groups. RESULTS: At the ankle joint, as measured by the α and ß angles (P > .05), the position of the components remained relatively similar in both the fixed- and mobile-bearing TAR at 24-month follow-up. The sagittal alignment, as measured by the TT (tibiotalar) ratio, demonstrated a posterior shifting of the talus in the mobile bearing group (P = .036). Although the fixed- and mobile-bearing TAR had both significant hindfoot alignment improvement between the preoperative radiographs and at 24 months, over time, the fixed-bearing ankle had a significant increase in both the hindfoot alignment view angle and hindfoot alignment distance (P < .001), suggesting a possible dynamism of the hindfoot in the fixed-bearing TAR. CONCLUSION: The lateral-approach fixed and anterior approach mobile-bearing implants maintained coronal and sagittal alignment in the short term; the temporal course of the lateral approach fixed-bearing ankle showed an increase in the valgus positioning of the hindfoot. The anterior approach mobile-bearing implant maintained its hindfoot alignment over the course of the study. LEVEL OF EVIDENCE: Level III, case-control study.