Analysis of Retrieved Agility™ Total Ankle Arthroplasty Systems

2009 ◽  
Vol 30 (9) ◽  
pp. 815-823 ◽  
Author(s):  
Zachary Vaupel ◽  
Erin A. Baker ◽  
Kevin C. Baker ◽  
Michael D. Kurdziel ◽  
Paul T. Fortin

Background: First generation total ankle arthroplasty (TAA) systems showed high rates of failure. The Agility™ (DePuy, Warsaw, IN) TAA system, a second generation design, had improved outcomes; however, implant failure due to loosening of the metallic components persisted. The purpose of this study was to analyze the damage modes and radiographic mode(s) of failure observed in retrieved Agility™ TAA. Materials and Methods: Ten devices were collected and each component was analyzed for common damage modes using microscopy. Clinical damage was analyzed with postoperative implant and preoperative revision procedure radiographs. Results: Analyses revealed damage/wear to retrieved components, including abrasion, dishing, and pitting. These third-body wear particles may be a precursor to wear debris induced osteolysis which could cause component loosening. Seven TAA systems were removed due to loosening or subsidence, suggesting component damage/wear may lead to clinically observed component loosening. Retrieval analysis indicated the polyethylene experiences edge loading, resulting in increased contact stresses to polyethylene in the primary articulation region and wear. Conclusion: Since poor clinical outcomes have been associated with component instability and osteolysis, analyzing retrieved components wear and damage may be an important step toward improving implant design, thereby decreasing wear debris induced osteolysis and improving clinical outcomes. Level of Evidence: IV, Case Series

2020 ◽  
Vol 41 (12) ◽  
pp. 1519-1528
Author(s):  
Jonathan Day ◽  
Jaeyoung Kim ◽  
Martin J. O’Malley ◽  
Constantine A. Demetracopoulos ◽  
Jonathan Garfinkel ◽  
...  

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.


2018 ◽  
Vol 40 (1) ◽  
pp. 9-17 ◽  
Author(s):  
Elizabeth A. Cody ◽  
Michel A. Taylor ◽  
James A. Nunley ◽  
Selene G. Parekh ◽  
James K. DeOrio

Background: A number of new 2-component total ankle arthroplasty systems that emphasize minimal bone resection have been introduced for which few clinical outcomes reports are available. Our aim was to identify the rate of early revision among patients receiving the 2-component INFINITY prosthesis. Methods: Patients from 2 prospectively collected databases at the authors’ institution were screened for inclusion in the present study. All patients who underwent a primary total ankle arthroplasty (TAA) with the INFINITY prosthesis and who were at least 1 year postoperative were included. A total of 159 ankles with a mean 20 months of follow up (range, 12-37) met these criteria. All surgeries were performed by 1 of 2 orthopedic foot and ankle surgeons with extensive experience in TAA. The primary outcome was the need for revision surgery, defined as removal of 1 or both metal components. Peri-implant lucency at most recent follow-up was a secondary outcome. Weightbearing radiographs at most recent follow-up were graded for lucency independently by 2 reviewers. Results: Sixteen ankles (10%) underwent revision at a mean 13 months postoperatively. The most common reasons for revision were symptomatic tibial component loosening and deep infection (6 patients each, 3.8%). Of the 108 ankles with retained components and at least 1 year of radiographic follow-up, 8 (7.4%) had global lucency around the tibial component suggestive of loosening at most recent follow-up. Conclusions: Our initial review of patients undergoing TAA with this new 2-component prosthesis demonstrates an elevated early revision rate due to tibial component loosening compared to other implant systems. Level of Evidence: Level IV, case series.


2019 ◽  
Vol 41 (4) ◽  
pp. 411-418 ◽  
Author(s):  
Hannu Tiusanen ◽  
Sami Kormi ◽  
Ia Kohonen ◽  
Mikhail Saltychev

Background: Total ankle arthroplasty is an alternative for arthrodesis. The objective of this study was to investigate the safety of trabecular-metal ankle prosthetic system with transfibular approach and external frame and its association with changes in clinical and functional scores. Methods: Between May 2013 and June 2017, a total of 104 consecutive patients underwent primary total ankle arthroplasty with a trabecular metal implant. The prospective clinical and radiographic data were collected. The mean follow-up time was 43.6 (14.6) months. Results: Of 104 patients, 88 (89%) reported improved functioning and 65 (66%) were very satisfied with the surgery. Of the patients, 51 (50%) did not report any pain at the end of follow-up at all. The average Kofoed score was 37.6 (SD 17.4) points at baseline and 74.8 (SD 20.6) points at the end of follow-up. There were 37 additional procedures, and the complication rate was nearly 20%. Conclusion: Trabecular-metal total ankle prosthesis showed promising clinical results concerning pain and function. At 5-year follow-up, osteolysis and component loosening were rare. Level of Evidence: Level IV, case series.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0016
Author(s):  
Daniel Bohl ◽  
Emily Vafek ◽  
Simon Lee ◽  
Johnny Lin ◽  
George Holmes ◽  
...  

Category: Ankle Arthritis Introduction/Purpose: Total ankle arthroplasty (TAA) is gaining popularity as an alternative to ankle arthrodesis in the setting of end-stage ankle arthritis. However, compared to hip and knee arthroplasty, there is a relative dearth of evidence to support its use. This study assesses the quality of literature surrounding modern TAA designs. Methods: A search of all peer-reviewed, English-language journals was conducted to identify publications involving TAA. The initial search identified 444 articles published during 2006-2016. Of these, 182 were excluded because they were not clinical outcomes studies, 46 because the TAA implant was no longer available, and 15 because the primary outcome of the study was not related to TAA, leaving 201 articles for analysis. Results: No Level I studies were identified. Seventeen (8%) studies were Level II, 48 (24%) Level III, 128 (64%) Level IV, and 8 (4%) Level V. One hundred forty-three studies (71%) were retrospective in nature. Stratification by study design revealed 128 (64%) case series, 33 (16%) experimental cohort studies, 19 (10%) case-control studies, 13 (6%) observational cohort studies, and 8 (4%) case reports. The number of studies published each year steadily increased from 2006 to 2016. A total of 51% of TAA research was published in only two journals: Foot and Ankle International and the Journal of Bone and Joint Surgery. Publications from the United States accounted for 36% of total publications. The most published implant was the Scandinavian Total Ankle Replacement (Figure 1). Conclusion: While the number of TAA studies published each year has steadily increased since 2006, the quality of this research as measured by level of evidence remains suboptimal. This analysis highlights the need for continued improvement in methodology and development of robust prospective registries to advance our knowledge of TAA as a treatment for end-stage ankle arthritis.


2019 ◽  
Vol 40 (8) ◽  
pp. 948-954
Author(s):  
Noriyuki Kanzaki ◽  
Nobuaki Chinzei ◽  
Tetsuya Yamamoto ◽  
Takahiro Yamashita ◽  
Kazuyuki Ibaraki ◽  
...  

Background: Total ankle arthroplasty (TAA) has been developed to treat patients with end-stage ankle osteoarthritis (OA). However, there is often difficulty in treating complicated pathologies such as ankle OA with subtalar joint OA and severe talar collapse. Therefore, this study aimed to explore the short-term results and complications of TAA with total talar prosthesis, known as combined TAA, as the new techniques to treat such complicated pathology. Methods: We examined postoperative results including ankle range of motion, Japanese Society for Surgery of the Foot (JSSF) scale, and complications. There were 22 patients (15 women), with mean follow-up of 34.9 (range, 24–53 months), and the mean age was 72 (range, 62–80) years. The main indications for combined TAA included osteoarthritis (18 patients), rheumatoid arthritis (3 patients), and talar osteonecrosis with osteoarthritis (one patient). Results: The mean range of motion improved from 4.0 to 14.4 degrees in dorsiflexion and from 23.8 to 32.0 degrees in plantarflexion. The JSSF scale improved from 50.5 to 91.5 points. Prolonged wound healing occurred in 3 patients, and medial malleolus fracture occurred in 4 patients. Conclusion: Combined TAA was a reliable procedure for the treatment of not only ankle OA following avascular necrosis of talus but also of degeneration of both ankle and subtalar joints. Level of Evidence: Level IV, case series.


2021 ◽  
pp. 107110072110600
Author(s):  
Oliver J. Gagne ◽  
Jonathan Day ◽  
Jaeyoung Kim ◽  
Kristin Caolo ◽  
Martin J. O’Malley ◽  
...  

Background: The use of total ankle arthroplasty (TAA) in the treatment of ankle arthritis has grown substantially as advancements are made in design and surgical technique. Among the criteria guiding the choice between arthroplasty and arthrodesis, the long-term survival and postoperative outcomes are of crucial importance. Although outcomes of the INBONE I have been published, there is limited midterm survival data for the INBONE II. The purpose of this study was to determine the radiographic and patient-reported outcomes, and survivorship of this prosthesis in patients with a minimum 5-year follow-up. Methods: We retrospectively identified 51 ankles (46 patients) from 2010 to 2015 who underwent TAA with the INBONE II prosthesis at our institution. Of these, 44 cases had minimum clinical follow-up of 5 years (mean, 6.4; range 5-9). Median age was 66 years (range 42-81) and median BMI was 27.5 (range 20.1-33.0). A chart review was performed to record the incidence of revision and reoperation. Preoperative and postoperative radiographs were analyzed to assess the coronal tibiotalar alignment (TTA), the talar inclination angle, and the presence of periprosthetic lucencies and cyst formation. Preoperative and minimum 5-year postoperative Foot and Ankle Outcome Score (FAOS) subscales were compared. Survivorship was determined by incidence of revision, defined as removal of a metallic component. Results: The survivorship at 5 years was 98% and the rate of reoperation was 7.8% (n = 4); 2 patients underwent irrigation and debridement for infection, 1 patient underwent a medializing calcaneal osteotomy, and 1 patient underwent open gutter debridement, 1 patient underwent a revision of a subsided talar component at 3.2 years after index surgery. Average postoperative TTA was 88.6 degrees, with 42 rated as neutral (85-95 degrees), 2 varus (<85 degrees), and no valgus (>95 degrees) ankles. At final follow-up, asymptomatic periprosthetic cysts were observed in 8 patients. All FAOS domain scores improved between preoperative and final follow-up. Conclusion: At midterm follow-up, we observed significant improvement in radiographic alignment and patient-reported outcome scores for the INBONE II total ankle prosthesis. In addition, this cohort has had a relatively low reoperation rate and high survivorship. Level of Evidence: Level IV, case series.


2021 ◽  
pp. 107110072097992
Author(s):  
Byung-Ki Cho ◽  
Min-Yong An ◽  
Byung-Hyun Ahn

Background: Total ankle arthroplasty (TAA) is known to be a reliable operative option for end-stage rheumatoid arthritis. However, higher risk of postoperative complications related to chronic inflammation and immunosuppressive treatment is still a concern. With the use of a newer prosthesis and modification of anti-rheumatic medications, we compared clinical outcomes after TAA between patients with osteoarthritis and rheumatoid arthritis. Methods: Forty-five patients with end-stage osteoarthritis (OA group) and 19 with rheumatoid arthritis (RA group) were followed for more than 3 years after 3 component mobile-bearing TAA (ZenithTM). Perioperative anti-rheumatic medications were modified using an established guideline used in total hip and knee arthroplasty. Clinical evaluations consisted of American Orthopaedic Foot & Ankle Society (AOFAS) scores, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM). Results: In the preoperative and postoperative evaluation at final follow-up, there were no significant differences in AOFAS, FAOS, and FAAM scores between 2 groups. Despite statistical similarity in total scores, the OA group showed significantly better scores in FAOS sports and leisure (mean, 57.4 ± 10.1) and FAAM sports activity (mean, 62.5 ± 13.6) subscales than those in the RA group (mean, 52.2 ± 9.8, P = .004; and 56.4 ± 13.2, P < .001, respectively). There were no significant differences in perioperative complication and revision rates between 2 groups. Conclusions: Patients with end-stage ankle RA had clinical outcomes comparable to the patients with OA, except for the ability related to sports activities. In addition, there were no significant differences in early postoperative complication rates, including wound problem and infection. Level of Evidence: Level III, prognostic, prospective comparative study.


2021 ◽  
pp. 107110072110438
Author(s):  
Brianna Fram ◽  
Daniel O. Corr ◽  
Ryan G. Rogero ◽  
David I. Pedowitz ◽  
Justin Tsai

Background: Total ankle arthroplasty (TAA) is an increasingly popular option for the operative treatment of ankle arthritis. The Cadence TAA entered clinical use in 2016 and was designed to address common failure modes of prior systems. We report early complications and radiographic and clinical outcomes of this total ankle system at a minimum of 2 years of follow-up. Methods: We performed a retrospective review of a consecutive cohort of patients undergoing primary Cadence TAA by a single surgeon from 2016 to 2017. Complications and reoperations were documented using the American Orthopaedic Foot & Ankle Society (AOFAS) TAA reoperation coding system. Patients completed the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) and Sport subscales, SF-12 Mental (MCS) and Physical (PCS) Component Summaries, and visual analog scale (VAS) pain rating (0-100). Radiographic evaluation was performed to assess postoperative range of motion (ROM) of the sole of the foot relative to the long axis of the tibia, alignment, and implant complications. Results: Fifty-eight patients with a mean age of 63.3 years and mean body mass index of 31.9 kg/m2 were included. Twelve of 58 patients (20.7%) underwent an additional procedure(s) within 2 years, including 3 (5.2%) who required removal of one or both components, 2 for infection and 1 for osteolysis. Forty-three patients were followed for a minimum of 2 years with radiographic imaging; 1 patient’s (2.3%) radiographs had signs of peri-implant osteolysis, with no cases demonstrating loosening or subsidence. FAAM-ADL, FAAM-Sport, SF-12 PCS, and VAS pain scores all improved at a mean of 27.4 months postoperatively, with mean score changes (± SD) of 16.3 (± 22.0), 25.3 (± 24.5), 6.0 (± 11.1), and −32.3 (± 39.8), respectively. Radiographic analysis revealed that average coronal alignment improved from 6.9 degrees from neutral preoperatively to 2.3 degrees postoperatively. The average ROM of the foot relative to the tibia was 36.5 degrees total arc of motion based on lateral radiographs. Conclusion: Early experience with this 2-component total ankle replacement was associated with a high component retention rate, improved coronal plane alignment, good postoperative ROM, radiographically stable implants, and improved patient function. Level of Evidence: Level IV, case series.


2020 ◽  
pp. 107110072097093
Author(s):  
Hyuck Sung Son ◽  
Jung Gyu Choi ◽  
Jungtae Ahn ◽  
Bi O Jeong

Background: In patients with end-stage varus ankle osteoarthritis (OA), hindfoot varus malalignment resulting from the varus deformity of the ankle joint is common. Although total ankle arthroplasty (TAA) performed to correct varus deformity of the ankle joint has the effect of correcting hindfoot alignment, no reports to date have described how much hindfoot alignment correction can be achieved. The purpose of this study was to identify correlation between ankle deformity correction and hindfoot alignment change after performing TAA in patients with end-stage varus ankle OA. Methods: A total of 61 cases that underwent TAA for end-stage varus ankle OA and followed up for at least 1 year were enrolled for this study. Correlation between changes of tibial-ankle surface angle (TAS), talar tilt (TT), and tibiotalar surface angle (TTS) and changes of hindfoot alignment angle (HA), hindfoot alignment ratio (HR), and hindfoot alignment distance (HD) measured preoperatively and at postoperative year 1 was analyzed. Results: TAS, TT, and TTS changed from 83.9 ± 4.1 degrees, 5.8 ± 5.0 degrees, and 78.1 ± 5.9 degrees, respectively, before operation to 89.2 ± 2.1 degrees, 0.4 ± 0.5 degrees, and 88.7 ± 2.3 degrees, respectively, after operation. HA, HR, and HD also changed from −9.2 ± 4.6 degrees, 0.66 ± 0.18, and −11.2 ± 6.9 mm to −3.7 ± 4.1 degrees, 0.48 ± 0.14, and −5.0 ± 5.3 mm. All the changes were statistically significant ( P < .001, respectively). The regression slope of correlation was 0.390 ( R2 = 0.654) between TTS and HA; 0.017 ( R2 = 0.617) between TTS and HR; and 0.560 ( R2 = 0.703) between TTS and HD. Conclusion: In patients with end-stage varus ankle OA, changes of hindfoot alignment could be predicted based on degree of ankle deformity corrected with TAA. Level of Evidence: Level IV, case series.


2008 ◽  
Vol 29 (11) ◽  
pp. 1069-1073 ◽  
Author(s):  
Stephen F. Conti ◽  
Derek Dazen ◽  
Gary Stewart ◽  
Aron Green ◽  
Rob Martin ◽  
...  

Background: Total ankle arthroplasty (TAA) is becoming an effective treatment for end-stage ankle arthritis. It is unknown if TAA alters the patient's ability to sense ankle joint position. Materials and Methods: Thirteen unilateral TAA patients with a minimum of 2-years followup completed proprioceptive testing of the TAA and the contralateral side. The task was to reproduce a given ankle angle using a joystick-driven device while the lower limb was obscured from view. Nine angles were tested, including two angles in dorsiflexion, three in plantarflexion, two in inversion, and two in eversion. A repeated-measures ANOVA was used to evaluate the results. Results: No statistically significant differences between the TAA ankle and the contralateral side were found. Conclusion: TAA does not cause a change in proprioceptive abilities in arthritis patients when compared to the contralateral, unaffected side in a small sample of unilateral patients. Surgeons and rehabilitation professionals may use this information when designing rehabilitation plans following the insertion of a TAA. Level of Evidence: III, Retrospective Case Series


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