scholarly journals Comparison of Tibial and Talar Bone Density as a Function of Resection Level in Patients Undergoing Total Ankle Replacement vs Demographic-Matched Controls

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0020
Author(s):  
Thos Harnroongroj ◽  
Lauren Volpert ◽  
Daniel Sturnick ◽  
Carolyn Sofka ◽  
Scott J. Ellis ◽  
...  
Keyword(s):  
Bone Density ◽  
Articular Surface ◽  
Weight Bearing ◽  
Total Ankle Replacement ◽  
Control Group ◽  
Ankle Arthritis ◽  
Relative Level ◽  
Percentage Decrease ◽  
Ankle Replacement ◽  
Significant Difference

Category: Ankle Arthritis Introduction/Purpose: Initial implant fixation is critical for long-term success of total ankle replacement (TAR). One important factor which contributes to implant stability is the quality of the surrounding bone. Previous studies characterized a decrease in bone density with increasing distance from the level of the joint in the tibia and talus in non-arthritic ankles. However, ankle arthritis affects bone density remains unclear. The objective of this study is to compare the bone density in patients with and without ankle arthritis as a function of resection level from the joint. We hypothesized that there would be no difference in bone densities at each resection level between groups and bone density would decrease with greater distance from articular surface in both groups. Methods: We retrospectively reviewed 93 end-stage ankle arthritis patients with available preoperative non-weight bearing ankle computed tomography scans (CT)(Group A) and identified another cohort of 83 patients with non-arthritic ankles as a demographic-matched control group(Group B). Patients with retained ankle hardware, history of osteomyelitis, osteoporosis, and cysts greater than 1 cm in diameter at the ankle were excluded. There was no difference in term of gender, age and body mass index (BMI) between the groups(Table 1). The ROI tool in Sectra IDS7 picture archiving and communication system (PACS) was used to calculate Hounsfield Unit (HU) values in the cancellous region of the tibia and talus around the ankle joint. Measurements were obtained on axial CTs from 6 mm to 12 mm above the distal tibial plafond, and from 1 mm to 4 mm below the talar dome. The HU measurements and percentage decrease of HU values at each level were compared between groups. Results: Patients with ankle arthritis demonstrated significantly greater bone density than the control group between 6 mm and 10 mm from the joint in the tibia. There was no significant difference in bone density between 10 mm and 12 mm from the joint on the tibia, and at all levels in the talus between groups (Table 1). In both groups, bone density decreased significantly at each successive level from the joint for the tibia and talus. In addition, the percentage decrease of HU values at each relative level was the same in both groups. Conclusion: Patients with ankle arthritis demonstrated greater bone density at 6 mm to 10 mm from the joint in the tibia compared to demographic-matched controls. The increased bone density close to the joint may stem from bone eburnation that occurs as part of the arthritic process. In TAR, a tibial bone resection between 6 mm and 10 mm may provide improved initial stability of the implant. Contrary to traditional thinking, fixation into the talus may be of less concern.

Comparison of Tibial and Talar Bone Density in Patients Undergoing Total Ankle Replacement vs Non–Ankle Arthritis Matched Controls

2019 ◽  
Vol 40 (12) ◽  
pp. 1408-1415
Author(s):  
Thos Harnroongroj ◽  
Lauren G. Volpert ◽  
Scott J. Ellis ◽  
Carolyn M. Sofka ◽  
Jonathan T. Deland ◽  
...  
Keyword(s):  
Bone Density ◽  
Ankle Joint ◽  
Articular Surface ◽  
Distal Tibia ◽  
Total Ankle Replacement ◽  
Control Group ◽  
Ankle Arthritis ◽  
Level Of Evidence ◽  
Ankle Replacement ◽  
Significant Difference

Background: Bone quality in the distal tibia and talus is an important factor contributing to initial component stability in total ankle replacement (TAR). However, the effect of ankle arthritis on bone density in the tibia and talus remains unclear. The objective of this study was to compare bone density of tibia and talus in arthritic and nonarthritic ankles as a function of distance from ankle joint. Methods: We retrospectively reviewed 93 end-stage ankle arthritis patients who had preoperative nonweightbearing ankle computed tomography (CT) and identified a cohort of 83 nonarthritic ankle patients as a demographic-matched control group. A region of interest tool was used to calculate Hounsfield unit (HU) values in the cancellous region of the tibia and talus. Measurements were obtained on axial cut CTs from 6 to 12 mm above the tibial plafond, and 1 to 4 mm below the talar dome. HU measurements between groups and the decrease of HU at the relative level in each group were compared. Results: Arthritic ankles demonstrated significantly greater mean bone density than nonarthritic ankles at between 6 and 10 mm above the joint in the tibia ( P < .05). No significant difference in bone density between 10 and 12 mm from the joint in the tibia nor at any level of the talus was found between groups. In both groups, bone density decreased significantly at each successive level away from the ankle joint. Conclusion: Ankle arthritis patients demonstrated greater or equal bone density in both the tibia and talus compared to demographic-matched controls. In both groups, bone density decreased with increasing distance away from the articular surface. In TAR, tibial bone resection between 6 and 8 mm may provide improved initial implant stability. Level of Evidence: Level III, comparative study.

scholarly journals Prospective Randomized Trial Comparing Mobile-bearing and Fixed-bearing Total Ankle Replacement

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0009
Author(s):  
James Nunley ◽  
Samuel Adams ◽  
James DeOrio ◽  
Mark Easley
Keyword(s):  
Clinical Outcomes ◽  
Mobile Bearing ◽  
Cyst Formation ◽  
Total Ankle Replacement ◽  
Fixed Bearing ◽  
Ankle Arthritis ◽  
Ankle Replacement ◽  
Significant Difference ◽  
End Stage

Category: Ankle Arthritis Introduction/Purpose: Outcomes of total ankle replacement for the treatment of end-stage ankle arthritis continue to improve. Debate continues whether a mobile-bearing total ankle replacement (MB-TAR) or a fixed-bearing total ankle replacement (FB-TAR) is superior, with successful outcomes reported longterm for MB-TAR and at intermediate-to-longterm follow-up for newer generation FB-TAR. Although comparisons between the two total ankle designs have been reported, to our knowledge, no investigation has compared the two designs with a high level of evidence. This prospective, randomized controlled trial conducted at a single institution compares patient satisfaction, functional outcomes and radiographic results of the mobile-bearing STAR and the fixed-bearing Salto-Talaris in the treatment of end-stage ankle arthritis. Methods: This investigation was approved by our institution’s IRB committee. Between November 2011 and November 2014, adult patients with end-stage ankle osteoarthritis failing nonoperative treatment were introduced to the study. With informed consent, 100 patients (31 male and 69 female, average age 65, range 35 to 85) were enrolled; demographic comparison between the two cohorts was similar. Exclusion criteria included inflammatory arthropathy, neuropathy, weight exceeding 250 pounds, radiographic coronal plane deformity greater than 15 degrees or extensive talar dome wear pattern (“flat top talus”). Prospective patient-reported outcomes, physical exam and standardized weightbearing ankle radiographs were obtained preoperatively, at 6 and 12 months postoperatively, and then at yearly intervals. Data collection included visual analog pain score (VAS), short form 36 (SF-36), foot and ankle disability index (FADI), short musculoskeletal functional assessment (SMFA) and AOFAS ankle-hindfoot score. Surgeries were performed by non-design team orthopaedic foot and ankle specialists with total ankle replacement expertise. Statistically analysis was performed by a qualified statistician. Results: At average follow-up of 4.5 years (range 2-6 years) complete clinical data and radiographs were available for 84 patients; 7 had incomplete data, one had died, 4 were withdrawn after enrolling but prior to surgery and 4 were lost to follow-up. In all outcome measures, the entire cohort demonstrated statistically significant improvements from preoperative evaluation to most recent follow-up. There was no statistically significant difference in improvement in clinical outcomes between the two groups. Radiographically, tibial lucency/cyst formation was 26.8% and 20.9% for MB-TAR and FB-TAR, respectively. Tibial settling/subsidence occurred in 7.3% of MB-TAR. Talar lucency/cyst formation occurred in 24.3% and 2.0% of MB-TAR and FB-TAR, respectively. Talar subsidence was observed in 21.9% and 2.0% of MB-TAR and FB-TAR, respectively. Re-operations were performed in 8 MB-TAR and 3 FB-TAR, with the majority of procedures being to relieve impingement or treat cysts and not to revise or remove metal implants. Conclusion: For the first time, with a high level of evidence, our study confirms that patient reported and clinical outcomes are favorable for both designs and that there is no significant difference in clinical improvement between the two implants. The incidence of lucency/cyst formation was similar for MB-TAR and FB-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence. As has been suggested in previous studies, clinical outcomes do not correlate with radiographic findings. Re-operations were more common for MB-TAR and in the majority of cases were to relieve impingement or treat cysts rather than revise or remove metal implants.

scholarly journals Transfibular Total Ankle Replacement Outcome at 2 Years Follow Up

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0002
Author(s):  
Camilla Maccario ◽  
Cristian Indino ◽  
Luigi Manzi ◽  
Federico Giuseppe Usuelli ◽  
Claudia Di Silvestri
Keyword(s):  
Normal Values ◽  
Short Form ◽  
Articular Surface ◽  
Total Ankle Replacement ◽  
Fixed Bearing ◽  
Trabecular Metal ◽  
Ankle Arthritis ◽  
Ankle Osteoarthritis ◽  
Ankle Replacement

Category: Ankle, Ankle Arthritis Introduction/Purpose: Primary ankle osteoarthritis is very uncomon, in fact 70-78% of the case ankle arthritis has a post- traumatic cause. Ankle arthrodesis (AA), has been considered a reliable procedure for resolution of ankle osteoarthritis. Recent modifications in Total ankle replacement (TAR) designs have challenged the perception that AA is the treatment of choice for end-stage ankle arthritis. Trabecular Metal Total Ankle system is a fixed-bearing prosthesis. The new design is flanked by use of new materials. The tibial articular surface is constructed of highly crosslinked UHMWPE and Trabecular Metal lining the talar and the tibial base component. The purpose of this retrospective study was to show the preliminary result in 31 patients underwent to ankle replacement using Zimmer Trabecular Metal Total Ankle system. Methods: We retrospectively assessed prospectively collected data on the initial cohort of 31 patients undergoing TAR with this implant. Clinical evaluation was determined pre and postoperatively for a minimum of 24 months after surgery. Pain was rated using the visual analogue scale (VAS). Functional results were assessed as well as ankle range of motion (ROM). Clinical outcomes used where the Short Form SF-12 Quality of Life score, the American Foot and Ankle Society (AOFAS). The imaging follow-up included ankle radiographs done at 6, 12 and 24 months. Radiological parameters were angles??(normal values 90 +- 2),?? (normal value 85 +- 2),??? normal values 20 +- 2) and TTratio? normal values: 27% to 42%). Results: The study included 31 ankles of TM Ankle Replacement in 31 consecutive patients over a period of 2 years (2013–2015). Out of 31 patients, 13 were females and 18 were males (average age 49.4 years, range, 30–75 years). All procedures were performed by a single surgeon. The ROM plantarflexion and dorsiflexion improved significantly (p <0.001) at the last follow up. The mean VAS pain score decreased significantly from 7.42 points (range 4 – 10 points) preoperatively to 1.42 points (range, 0 - 3 points) at the time of the latest follow-up (p <0.001). AOFAS and SF-12 scores both improved from postoperatively to the last follow up. (Table 1). We noted stable implants based on our radiographic parameters, with no corrections loosening. (Table 2) Conclusion: Our study evaluated the new fixed bearing Zimmer TM total ankle replacement approved by the US FDA in 2012 and is the first studies to evaluate the clinical and radiographic outcomes of this prosthesis. Of 31 ankles treated with a new transfibular arthroplasty system, only two asymptomatic fibular delayed union were registered. No implant failure was noted at 24 months postoperatively. Four ankles underwent secondary surgery for symptomatic fibular hardware with good outcome. The findings suggest that this total ankle system is safe and effective at short-term follow-up.

scholarly journals Should 15° of Valgus Coronal-Plane Deformity Be the Upper Limit for a Total Ankle Replacement?

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0006
Author(s):  
Mansur Halai ◽  
Matthew Mann ◽  
Ryan Khan ◽  
Ellie Pinsker ◽  
Timothy Daniels
Keyword(s):  
Short Form ◽  
Valgus Deformity ◽  
Total Ankle Replacement ◽  
Coronal Plane ◽  
Control Group ◽  
Ankle Arthritis ◽  
Ankle Replacement ◽  
Sf 36 ◽  
Plane Deformity

Category: Ankle Arthritis Introduction/Purpose: Preoperative talar valgus deformity increases the technical difficulty of total ankle replacement (TAR) and is associated with an increased failure rate. Deformity of ≥15° has been reported to be a contraindication to arthroplasty. The goal of the present study was to determine whether the clinical outcomes of TAR for treatment of end-stage ankle arthritis were comparable for patients with preoperative talar valgus deformity of ≥15° as compared to those with <15°. Methods: Fifty ankles with preoperative coronal-plane tibiotalar valgus deformity of ≥15° (“valgus” group) and 50 ankles with valgus deformity of <15° (“control” group) underwent TAR. The cohorts were similar with respect to demographics and components used. All TARs were performed by a single surgeon. The mean duration of clinical follow-up was 5.5 years (minimum two years). Preoperative and postoperative radiographic measurements of coronal-plane deformity, Ankle Osteoarthritis Scale (AOS) scores and Short Form (SF)-36 scores were prospectively recorded. All ancillary (intraoperative) and secondary procedures, complications and measurements were collected. Results: The AOS pain and disability subscale scores decreased significantly in both groups. The improvement in AOS and SF-36 scores did not differ significantly between the groups at the time of the final follow-up. The valgus group underwent more ancillary procedures during the index surgery (80% vs 26%). Tibio-talar deformity improved significantly toward a normal weight-bearing axis in the valgus group. Secondary postoperative procedures were more common in the valgus group (36%) than the controls (20%). Overall, re-operation was not associated with poorer patient outcome scores. Metal component revision surgery occurred in seven patients (three valgus and four controls). These revisions included two deep infections (2%), one in each group, which were converted to hindfoot fusions. Therefore, 94% of the valgus group retained their original components at final follow-up. Conclusion: Satisfactory midterm results were achieved in patients with valgus mal-alignment of ≥15°. The valgus cohort required more procedures during and after their TAR, as well as receiving more novel techniques to balance their TAR. Whilst longer term studies are needed, valgus coronal-plane alignment of ≥15° should not be considered an absolute contraindication to TAR if the associated deformities are addressed.

scholarly journals The Ankle-Hindfoot Kinematics of Current Generation Total Ankle Replacement: A Cadaveric Gait Simulation

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0020
Author(s):  
Thos Harnroongroj ◽  
Daniel Sturnick ◽  
Scott J. Ellis ◽  
Constantine Demetracopoulos ◽  
Jonathan Deland
Keyword(s):  
Joint Kinematics ◽  
Total Ankle Replacement ◽  
Patient Specific ◽  
Fixed Bearing ◽  
Ankle Arthritis ◽  
Current Generation ◽  
Gait Simulation ◽  
Ankle Replacement ◽  
Wright Medical Technology ◽  
Significant Difference

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement (TAR) has developed as a standard treatment option for end-stage ankle arthritis with the primary benefit of pain relief and ankle-hindfoot motion preservation. The current generation of TARs features limited bone resection and improved initial fixation of components to restore physiologic constraint and the anatomic articulation of the ankle. However, the ankle-hindfoot kinematics of current TAR designs compared to the baseline native ankle have not yet been extensively studied. Cadaveric gait simulation is a valuable tool for investigating direct effects of surgical procedures on foot and ankle biomechanics. The objective of this study was to assess whether this current generation TAR system could provide normal ankle-hindfoot kinematics as the baseline native ankle using cadaveric gait simulation. Methods: Eleven mid-tibia cadaveric specimens were secured to a static mounting fixture with a six-degree of freedom robotic platform to simulate gait in native-intact and TAR conditions. A force plate was moved relative to the stationary specimen through an inverse tibial kinematic path calculated from in vivo data while extrinsic tendons were actuated using physiologic loads (Figure 1A). Ankle-hindfoot kinematics were measured from reflective markers attached to bones via surgical pins. TAR was performed using a current generation, fixed-bearing system by a fellowship-trained foot-ankle surgeon using the manufacturer described protocol (PROPHECY Patient-specific instrumentation, Infinity, Wright Medical Technology). Ankle-hindfoot joint kinematics were measured using the same tibial kinematic inputs and muscle forces as the intact condition. Non-parametric, bias-corrected bootstrapping was used to calculate 95% confidence intervals to compare motion between intact and total ankle replacement. Results: Analyses demonstrated no significant difference in average ankle-hindfoot joint kinematics between the intact and TAR conditions (Figure 1B). The result was consistent for the ankle, subtalar, and talonavicular joints, in each plane of motion. Conclusion: These findings demonstrate that the current generation of fixed-bearing TAR can recreate normal ankle-hindfoot kinematics patterns seen in normal ankles. Restoring ankle kinematics can be a significant factor in slowing down the progression of adjacent joint arthritis in the foot. However, it is still inconclusive whether ankle-hindfoot kinematics can be restored in patients with long standing ankle arthritis, and this should be addressed in future studies.

scholarly journals Ankle and Hindfoot Kinematics of a Next Generation Total Ankle Replacement During Simulated Gait

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0011
Author(s):  
Daniel Sturnick ◽  
Guilherme Saito ◽  
Scott Ellis ◽  
Constantine Demetracopoulos
Keyword(s):  
Joint Kinematics ◽  
Total Ankle Replacement ◽  
Foot And Ankle ◽  
Next Generation ◽  
Fixed Bearing ◽  
Ankle Arthritis ◽  
Gait Simulation ◽  
Ankle Replacement ◽  
Significant Difference

Category: Ankle Arthritis Introduction/Purpose: Total ankle arthroplasty (TAA) has developed as a viable treatment option for end-stage ankle arthritis. The primary benefit proposed with TAA is that allows for maintained motion of the ankle and hindfoot joint compared to the alternative option of an ankle arthrodesis. Consequently, recent TAA systems have focused on designs that advance kinematic function. Cadaveric gait simulation is a valuable tool for investigating the direct effects of surgical procedures and devices on foot and ankle biomechanics. The objective of this study was to assess whether a next generation TAA system permits normal ankle and hindfoot kinematics using cadaveric gait simulation. Methods: Ten mid-tibia cadaveric specimens were secured to a static mounting fixture relative a six-degree of freedom robotic platform to simulate gait in native-intact and TAA conditions. A force plate was moved relative to the stationary specimen through an inverse tibial kinematic path calculated from in vivo data while extrinsic tendons were actuated using physiologic loads (Figure 1A). Ankle and hindfoot kinematics were measured from reflective markers attached to bones via surgical pins. TAA was performed using a next generation, fixed bearing total ankle system by a fellowship trained foot and ankle surgeon using manufacturer described protocol (Cadence Total Ankle, Integra LifeSciences). Ankle and hindfoot joint kinematics were directly measured using the same kinematic inputs and muscle force as the intact condition. Non-parametric, bias-corrected bootstrapping was used to calculate 95% confidence intervals to compare motion between intact and total ankle replacement conditions. Results: Analyses revealed that no significant difference in average ankle or hindfoot joint kinematics were found between intact and TAA conditions (Figure 1B). This result was consistent in each the ankle, subtalar, and talonavicular joints, and in each plane of motion. Conclusion: This study found that normal kinematics were permitted on average by a next generation, fixed bearing TAA. This finding may indicate that improved functional outcomes following could be expected. However, increased variability and some characteristic differences in the paths of motion throughout stance were observed qualitatively. This report represents an initial analysis of preliminary data, future work will include further analyses and investigation on the influence of factors such as component position and alignment on outcomes. That said, the findings of this study are encouraging and may represent improved kinematic performance in new TAA designs.

scholarly journals Age-Related Outcome of Mobile-Bearing Total Ankle Replacement

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0002
Author(s):  
Camilla Maccario ◽  
Ettore Vulcano ◽  
Cristian Indino ◽  
Luigi Manzi ◽  
Federico Giuseppe Usuelli
Keyword(s):  
Mobile Bearing ◽  
The Elderly ◽  
Young Group ◽  
Total Ankle Replacement ◽  
Ankle Arthritis ◽  
Short Term Treatment ◽  
Age Related ◽  
Ankle Replacement ◽  
Significant Difference ◽  
End Stage

Category: Ankle, Ankle Arthritis Introduction/Purpose: Total ankle replacement (TAR) is becoming increasingly popular amongst patients with end-stage ankle arthritis. This is in part related to the advances in design, technology, and technique that have improved TAR longevity. The ideal candidate for a TAR is not fully clear. For a long time patients over age 50 years, body mass index (BMI) under 30 kg/m2, and with low functional demands represented selection criteria for many patients. However, these criteria were based off a very limited number of scientific studies on older TAR designs. The aim of this study is to investigate clinical and radiographic outcome in patients of 50 years or less versus patients over 50 years undergoing a Hintegra® total ankle replacement (Integra, Plainsboro, NJ). Methods: This study includes 70 consecutive patients who underwent primary TAR from May 2011 to April 2014. The cohort was divided into 2 groups: the young group (YG) with age less than or equal to 50 years, and the older group (OG) with age above 50 years. Patients were assessed clinically and radiologically preoperatively and at 6, 12 and 24 months postoperatively. Results: A significant increase in the AOFAS and SF-12 and decrease in VAS scores was seen in both groups between preoperative and final followup (p < 0.001). There was a statistically significant difference between the YG and OG for the AOFAS score at final follow-up. The YG had significantly greater improvement compared to the OG (p = 0.046). In addition radiographic results showed no statistically significant difference in the coronal and sagittal alignment between the 2 groups. The mean postoperative angles in either study group demonstrated significant improvements compared to the preoperative alignment. Conclusion: This study demonstrates that total ankle arthroplasty is an effective short-term treatment for young, active patients with symptomatic end-stage ankle arthritis. Our findings are in disagreement with the widespread theory that ankle replacement is a more reliable treatment in the elderly

Total Ankle Arthroplasty Survivorship, Complication, and Revision Rates in Patients Younger Than 55 Years

2021 ◽  
pp. 193864002098092
Author(s):  
Devon W. Consul ◽  
Anson Chu ◽  
Travis M. Langan ◽  
Christopher F. Hyer ◽  
Gregory Berlet
Keyword(s):  
Case Series ◽  
Ankle Arthrodesis ◽  
Total Ankle Replacement ◽  
Implant Survival ◽  
Ankle Arthritis ◽  
Single Institution ◽  
Retrospective Case ◽  
Ankle Replacement ◽  
End Stage

Total ankle replacement has become a viable alternative to ankle arthrodesis in the surgical management of advanced ankle arthritis. Total ankle replacement has generally been reserved for patients who are older and for those who will have a lower demand on the replacement. The purpose of the current study is to review patient outcomes, complications, and implant survival in patients younger than 55 years who underwent total ankle replacement at a single institution. A single-center chart and radiographic review was performed of consecutive patients who underwent total ankle replacement for treatment of end-stage ankle arthritis. All surgeries were performed by 1 of 5 fellowship-trained foot and ankle surgeons at a single institution. A total of 51 patients met inclusion criteria with a mean follow-up of 31.2 months (SD = 16.2). Implant survival was 94%, There were 7 major complications (13%) requiring an unplanned return to the operating room and 8 minor complications (15%) that resolved with conservative care. The results of this study show that total ankle replacement is a viable treatment option for patients younger than 55 years. Levels of Evidence: A retrospective case series

scholarly journals Adverse Events in Total Ankle Arthroplasty, Analysis of the FDA Medical and User Facility Device Experience Database

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0028
Author(s):  
Karim Mahmoud ◽  
Sreenivasulu Metikala ◽  
Kathryn O’Connor ◽  
Daniel Farber
Keyword(s):  
Adverse Events ◽  
Aseptic Loosening ◽  
Mandatory Reporting ◽  
Total Ankle Replacement ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthritis ◽  
Ankle Arthroplasty ◽  
Ankle Replacement ◽  
Mode Of Failure ◽  
User Facility

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement has become a popular treatment option for end stage ankle arthritis. Most of the reports of adverse events following total ankle replacement have been from high volume institutions and are subject to either observational or selection bias as well as potential under-reporting as they do not include the experience of community and lower volume centers and surgeons. The FDA’s Medical and User Facility Device Experience (MAUDE) Database provides a more complete scope of adverse events due to the mandatory reporting requirements by the FDA of implant manufactures. We reviewed the database to identify the common modes of failure and complications of total ankle implants Methods: We retrospectively reviewed reports of the MAUDE database from November 2011 to September 2018 regarding all total ankle implants. Each device in the MAUDE database is classified with a 3-letter code, we identified the 2 codes assigned to total ankle arthroplasty devices, and manually searched the FDA’s published Device Classification list for adverse events. All events were reviewed and classified. Data related to patient age or sex, surgeon, medical center location are not available in the database Results: We identified 1000 adverse reports in the period between November 2011 and September 2018. After exclusion of duplicate reports for single events or reports irrelevant to total ankle arthroplasty, a total of 697 adverse event reports were noted. The most common mode of failure was aseptic loosening (21%), followed by infection (16%), alignment and mechanical issues (instability, malalignment, malposition, stiffness, impingement) (15%), implantation issues (pin, screw or drill breakage, alignment guide problems) (9%), polyethylene related problems (wear, displaced or fractured implants) (7%), bony and soft tissue overgrowth (6%), and peri-prosthetic fractures (5%). Conclusion: Our analysis reveals that the most reported mode of failure was aseptic loosening followed by infection. However, it is notable that there are a significant number of issues with implant alignment and mechanics, complications during implantation and polyethylene component failure that are under-reported in the literature. Knowledge of these adverse events may help surgeons avoid similar complications as well as lead to improvement in component implantation and design

scholarly journals Early Clinical and Radiographic Outcomes of Trabecular Metal Total Ankle Using Transfibular Approach

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0001 ◽  
Author(s):  
Alexej Barg ◽  
Charles Saltzman
Keyword(s):  
Range Of Motion ◽  
Weight Bearing ◽  
Total Ankle Replacement ◽  
Trabecular Metal ◽  
Non Union ◽  
Early Loosening ◽  
Early Results ◽  
Ankle Replacement ◽  
Patient Reported

Category: Ankle, Ankle Arthritis Introduction/Purpose: In the last two decades, total ankle replacement (TAR) has gained more acceptance as a treatment option in patients with end-stage ankle osteoarthritis. However, there is a lack of literature on TAR using a lateral transfibular approach. Therefore, we sought to report early clinical and radiographic results of a patient cohort treated with TAR using a lateral transfibular approach by a single surgeon. Methods: Fifty-five primary total ankle arthroplasties using the Zimmer trabecular metal implant were performed in 54 patients (29 men and 25 women; mean age, 67.0 years) from October 2012 to December 2014. Clinical assessment including pain evaluation and measurement of ankle range of motion was done preoperatively and at the latest follow-up. Weight-bearing radiographs were used to determine the angular alignment of the tibial and talar components and to analyze the bone-implant interface. Intraoperative and postoperative complications, revision surgeries, and failures were evaluated. Results: Implant survival was 93% at 36 months follow-up. There were 3 revisions of a tibial component due to aseptic loosening. In 10 of 55 procedures, a secondary procedure was performed during follow-up. Mean follow-up duration was 26.6 ± 4.2 months. No delayed union or non-union was observed for fibula healing. The average VAS pain score decreased significantly from 7.9 ± 1.3 to 0.8 ± 1.2. The average total range of motion increased significantly from 22.9° ± 11.8° to 40.2° ± 11.8°. Conclusion: Early results of Zimmer trabecular metal total ankle replacement demonstrated improved patient-reported outcomes and increased ankle motion at a minimum follow-up of one year. In the first 55 consecutive cases, the fibular osteotomy required for access to the ankle healed without complications. Painful early loosening requiring revision due to lack of bony ingrowth was seen in 3 of 55 cases.

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