Early Prospective Results of the Salto-Talaris™ Total Ankle Prosthesis

2012 ◽  
Vol 2 (1) ◽  
pp. 23-34 ◽  
Author(s):  
Karl M Schweitzer ◽  
Samuel B Adams ◽  
Nicholas A Viens ◽  
Robin M Queen ◽  
Mark E Easley ◽  
...  

ABSTRACT Background Several fixed-bearing total ankle arthroplasty (TAA) systems are available in the United States (US). We report on the early clinical results of the largest known US cohort of patients who received a Salto-Talaris total ankle replacement for end-stage ankle arthritis. Methods We prospectively followed 67 TAA patients with a minimum clinical follow-up of 2 years. Patients completed standardized assessments, including visual analog scale (VAS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot score, short form (36) health survey (SF-36), and the short musculoskeletal function assessment (SMFA), along with physical examination, functional assessment, and radiographic evaluation, preoperatively and yearly thereafter through most recent follow-up. Results Implant survival was 96% using metallic component revision, removal, or impending failure as endpoints, with a mean follow-up of 2.81 years. Three patients developed aseptic loosening, all involving the tibial component. Of these, one underwent revision to another fixed-bearing TAA system, one patient is awaiting revision surgery, and the other patient has remained minimally symptomatic and fully functional without additional surgery. Forty-five patients underwent at least one additional procedure at the time of their index surgery. The most common concurrent procedure performed was a deltoid ligament release (n = 21), followed by removal of previous hardware (n = 16) and gastrocnemius recession (n = 11). Eight patients underwent additional surgery following their index TAA, most commonly debridement for medial and/or lateral impingement (n = 4). Patients demonstrated significant improvement in VAS, AOFAS hindfoot, several SF-36 subscales, SMFA, and functional scores at most recent follow-up (p < 0.001). Conclusion Early clinical results indicate that the Salto-Talaris fixed-bearing TAA system can provide significant improvement in pain, quality of life, and standard functional measures in patients suffering from end-stage ankle arthritis. The majority of patients underwent at least one concurrent procedure, most commonly to address varus hindfoot deformity, hardware removal, or equinus contracture. Schweitzer Jr KM, Adams Jr SB, Viens NA, Queen RM, Easley ME, DeOrio JK, Nunley II JA. Early Prospective Results of the Salto-Talaris™ Total Ankle Prosthesis. The Duke Orthop J 2012;2(1):23-34.

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0003 ◽  
Author(s):  
Matthew Stewart ◽  
James DeOrio ◽  
Samuel Adams ◽  
Mark Easley ◽  
James Nunley

Category: Ankle Arthritis Introduction/Purpose: The Salto Talaris total ankle replacement is a modern fixed-bearing implant used to treat symptomatic ankle arthritis with the goals of providing pain relief, restoring mechanical alignment, and allowing motion of the ankle joint. This prosthesis has been used in the United States increasingly over the last 10 years, primarily for older patients with end-stage ankle arthritis but indications are expanding to younger and more active patients. The goal of this study is to report the midterm clinical results of one of the largest cohort of patients in the United States who underwent ankle replacement with this prosthesis. Methods: This is a review of patients with a minimum of 5-year up to 10-year follow-up who were prospectively registered within our institutional database prior to proceeding with total ankle arthroplasty using the Salto Talaris prosthesis. Follow-up examinations were scheduled annually after the one-year postoperative mark to evaluate patients both clinically and radiographically. At each annual assessment, patients rated their current level of pain using the visual analog score (VAS) and reported their functional level using the American Orthopaedic Foot and Ankle (AOFAS) ankle-hindfoot scores, the Short Musculoskeletal Function Assessment (SMFA), and the Short Form-36 (SF-36) Health survey. These scores were analyzed to assess differences between their levels preoperatively, one year postoperatively and at their most recent follow-up. Preoperative and postoperative radiographs were reviewed for component loosening. Criteria for failure was defined as undergoing revision requiring exchange or removal of the metallic components for any reason. Results: We identified 106 patients who had a Salto Talaris total ankle replacement between March 2007 and February 2012. Of these, 72 patients (mean age, 61.9 years) met the requirement for a minimum follow-up of 5 years (range 60 to 115 months, mean 81.1 months). Average outcome in the VAS was 7.1 at one year post-op and 11.7 at last follow-up (preop: 70.0). Significant improvements were seen in the SMFA, AOFAS ankle-hindfoot score, and the SF-36 from preoperatively to their final follow-up. Survivorship was 97.2% with two patients undergoing revision arthroplasty for aseptic loosening and a third patient scheduled for revision for a chronic wound infection. 14 patients (19%) with midterm follow-up required a total of 17 additional surgical procedures on the ipsilateral ankle or hindfoot. Conclusion: Patients who underwent total ankle arthroplasty with the Salto Talaris prosthesis have continued to show significant improvements in pain and functional outcomes at mid-term follow-up. This has shown to be an effective treatment option with durable results for patients with end-stage ankle arthritis.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0009
Author(s):  
James Nunley ◽  
Samuel Adams ◽  
James DeOrio ◽  
Mark Easley

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.


2021 ◽  
pp. 107110072110151
Author(s):  
Michael D. Johnson ◽  
Jane B. Shofer ◽  
Sigvard T. Hansen ◽  
William R. Ledoux ◽  
Bruce J. Sangeorzan

Background: Ankle coronal plane deformity represents a complex 3-dimensional problem, and comparative data are lacking to guide treatment recommendations for optimal treatment of end-stage ankle arthritis with concomitant coronal plane deformity. Methods: In total, 224 patients treated for end-stage ankle arthritis were enrolled in an observational trial. Of 112 patients followed more than 2 years, 48 patients (19 arthrodesis, 29 arthroplasty) had coronal plane deformity and were compared to 64 patients without coronal plane deformity (18 arthrodesis, 46 arthroplasty) defined as greater than 10 degrees of varus or valgus. The arthroplasty implants used had different internal constraints to intracomponent coronal plane tilting. Patients completed Musculoskeletal Functional Assessment (MFA) and SF-36 preoperatively and at 3, 6, 12, 24, and 36 months postoperatively. Measures included change in SF-36 and MFA, as well as compared reoperation rates and pain scales. Results: For the groups with coronal plane ankle deformity, the median for the arthrodesis group was 19.0 degrees and the median for the arthroplasty group was 16.9 degrees. In the deformity cohort during the follow-up period, we had 7 major reoperations: 2 in the arthrodesis group and 5 in the arthroplasty group, all with the less constrained implant design. MFA, vitality, and social function of the SF-36 improved for all groups. Patients without preoperative deformities had greater improvement with fusion or replacement at both 2 and 3 years. There was no difference in improvement between those patients with coronal deformity who received arthroplasty vs arthrodesis. Conclusion: Patients with and without coronal plane deformity may benefit from ankle arthroplasty and arthrodesis, although greater improvements may be expected in those without preoperative deformity. In this study, at final follow-up of 3 years, overall we found no meaningful difference in patient-reported outcomes between the patients with preoperative coronal plane deformities whether they had a fusion or a replacement as treatment for end-stage ankle arthritis. Level of Evidence: II, comparative study.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0013
Author(s):  
Kevin Wing ◽  
Jason Sutherland ◽  
Timothy Daniels ◽  
Peter Dryden ◽  
Murray Penner ◽  
...  

Category: Ankle Arthritis Introduction/Purpose: There is much interest in the surgical treatment of end-stage ankle arthritis. Our team has previously reported comparisons between ankle fusion and replacement outcomes for 321 ankles at 5.5 years from a prospective cohort. This research extends the observational period for another six years, ending in 2013. Our primary hypothesis is that patient-reported clinical outcomes for ankle fusion and replacements would be similar at last follow up. Methods: Patients in the Canadian Orthopaedic Foot and Ankle Society (COFAS) Prospective Ankle Reconstructive Database were treated with total ankle replacement (involving Agilty, Star, Mobilty, Hintegra, or Inbone) or fusion (open or arthroscopic). Patient characteristics collected included demographics, comorbidities, smoking status and body mass index. Patient-reported outcomes (PROs) completed by patients were the Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36). Pre-operative and most recent patient data, with at least four years follow-up, were analyzed. Sensitivity analyses excluded ankles that had undergone revision. A linear mixed-effects regression model compared scores between total ankle replacement and fusion groups, adjusting for patient characteristics, baseline data and surgeon. Results: The sample included 844 ankles (556 ankle replacements and 284 arthrodesis). The mean follow up period was 8.0 years (standard deviation 3.1 years), with minimum and maximum of 4 and 14 years, respectively. Patients treated with arthrodesis were younger, more likely to be diabetic and smokers, and somewhat less likely to have inflammatory arthritis. Overall, 19.4% of ankle fusion and 30.8% of ankle replacements underwent all-cause re-operation. The mean AOS total score improved from 58.6 points pre-operatively to 31.4 post-operatively (delta 27.2), and from 57.0 to 26.9 points (delta 30.1) in the ankle replacement group. Differences in the change in AOS and SF-36 scores between the arthrodesis and ankle replacement groups were minimal after adjustment for baseline characteristics and surgeon. Conclusion: Clinical outcomes of total ankle replacement and ankle arthrodesis were comparable in a diverse cohort of patients whose follow up period ranged between 4 and 14 years post-operatively.


2021 ◽  
Vol 10 (24) ◽  
pp. 5915
Author(s):  
Jeong-Jin Park ◽  
Whee-Sung Son ◽  
In-Ha Woo ◽  
Chul-Hyun Park

The transfibular approach is a widely used method in ankle arthrodesis. However, it is difficult to correct coronal plane deformity. Moreover, it carries a risk of nonunion and requires long periods of non-weight-bearing because of its relatively weak stability. We hypothesized that the transfibular approach combined with the anterior approach in ankle arthrodesis wound yield a higher fusion rate and shorter non-weight-bearing period. This study was performed to evaluate the clinical and radiographic results and postoperative complications in ankle arthrodesis using combined transfibular and anterior approaches in end-stage ankle arthritis. Thirty-five patients (36 ankles) with end-stage ankle arthritis were consecutively treated using ankle arthrodesis by combined transfibular and anterior approaches. The subjects were 15 men and 20 women, with a mean age of 66.5 years (46–87). Clinical results were assessed using the visual analog scale (VAS) for pain, the American Orthopaedic Foot and Ankle Society (AOFAS) scores, and the ankle osteoarthritis scale (AOS) preoperatively and at the last follow-up. Radiographic results were assessed with various radiographic parameters on ankle weight-bearing radiographs and hindfoot alignment radiographs. All clinical scores significantly improved after surgery. Union was obtained in all cases without additional surgery. Talus center migration (p = 0.001), sagittal talar migration (p < 0.001), and hindfoot alignment angle (p = 0.001) significantly improved after surgery. One partial skin necrosis, two screw penetrations of the talonavicular joint, and four anterior impingements because of the bulky anterior plate occurred after surgery. In conclusion, combined transfibular and anterior approaches could be a good method to increase the union rate and decrease the non-weight-bearing periods in ankle arthrodesis.


2014 ◽  
Vol 17 (1) ◽  
pp. 18-24
Author(s):  
Seung Bum Chae ◽  
Chang Hyuk Choi ◽  
Suk Han Jung

BACKGROUND: To evaluate the efficacy of the subclavian portal approach for the arthroscopic repair of isolated subscapularis tendon tear.METHODS: We used the subclavian portal to carry out arthroscopic repair of the isolated subscapularis tendon tear. The surgery was carried out in 18 cases (average age of 53) from May 2006 to December 2009 with a mean follow-up period of 35 months. Of these cases, 13 patients had the tear in their dominant arms, 16 were male, and 12 were from traumatic ruptures with on average 7.6 months of symptom period to operation. Additional surgery, acromioplasty and subacromial debridement, were carried out on 4 cases each during the subscapularis repair. The integrity of cuff status was assessed by ultrasonographic examination at 6 months and at 1 year after operation.RESULTS: The initial average range of motion in forward flexion, external rotation, and internal rotation were 160degrees, 50degrees and L4, respectively. At the 1 year follow-up period, these improved to 160degrees, 52degrees and T12, respectively. The initial average functional scores were assessed by KSS, ASES, UCLA, and Constant scoring systems, which were 67, 60, 26, and 65, respectively. These scores improved progressively with time. At 3 months after operation, the scores were 74, 67, 27, and 74; at 6 months, 83, 77, 31, and 75; at 1 year, 88, 86, 32, and 79; and at the final follow-up of 35 months, 84, 92, 34, and 84.CONCLUSIONS: In the repair of isolated subscapularis tendon tear, the subclavian portal approach provided a good angle for anchor insertion and sufficient space to manage the upper portion of the tendon tear. In turn, these provisions resulted in satisfactory clinical results.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0042
Author(s):  
Calvin J. Rushing ◽  
Christopher F. Hyer ◽  
Gregory C. Berlet

Category: Ankle Arthritis; Ankle; Other Introduction/Purpose: The INFINITY total ankle prosthesis remains the most widely used 4th generation total ankle arthroplasty (TAA) system in the United States. The purpose of the present study was to assess outcomes for the INFINITY prosthesis at short-term follow-up. Methods: All patients who underwent primary TAA with INFINITY between August 2015 and June 2018 at a single institution and who were at least 1 year postoperative were included. A total of 55 ankles with a mean follow up 22 (range, 12-43) months met the criteria. Weightbearing radiographs were assessed using coronal and sagittal alignment parameters preoperatively, at 6- 8 weeks postoperatively, and at the most recent follow-up. Medical records and charts were reviewed and revisions, reoperations, and complications were classified according to the criteria established by Vander Griend et al. and Glazebrook at el., respectively. Results: Overall survivorship for the INFINITY prosthesis was 98.2%. Coronal and sagittal tibiotalar alignment improved after surgery (p<.001, p=0.09), and was maintained during the latest follow-up (p=0.62, p=0.47). One ankle (1.8%) required early component revision; while 5 (9.1%) required non-implant related revision. Postoperative periprosthetic lucency’s were observed in nineteen ankles (34.5%); most of which were non-progressive (17 ankles, 89.5%). Thirteen complications (3 high grade, 3 intermediate, and 7 low) in 11 ankles (20%) were recorded according to the Glazebrook classification system. Conclusion: INFINITY survivorship was 98.2% at a mean of 1.8 years of follow-up, with only 1 ankle requiring prosthetic revision. Additional studies with longer follow-up are warranted for 4th generation TAA prostheses.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0003
Author(s):  
Elizabeth Cody ◽  
Constantine Demetracopoulos ◽  
Samuel Adams ◽  
James DeOrio ◽  
James Nunley ◽  
...  

Category: Ankle Arthritis Introduction/Purpose: Among patients with end-stage ankle arthritis, total ankle arthroplasty (TAA) utilization has significantly increased in recent years, while ankle arthrodesis utilization has declined. Significant coronal plane deformity is frequently encountered in this patient population, and was previously considered a contraindication to TAA. However, the advent of newer fixed-bearing prostheses, coupled with improved surgical techniques and a better understanding of ligamentous balancing, have allowed surgeons to extend their indications for TAA with respect to deformity correction. Several authors have demonstrated good outcomes from TAA in patients with significant varus deformities, but not specifically in patients with valgus deformities. We aimed to determine the clinical, radiographic, and patient-reported outcomes of patients with moderate to severe valgus deformity who underwent TAA for end-stage ankle arthritis. Methods: Eighty patients with valgus deformities =10 degrees who underwent TAA were retrospectively reviewed. All surgeries were performed by one of three fellowship-trained orthopaedic foot and ankle surgeons with extensive experience in TAA. One of three prostheses were used: INBONE (Wright Medical Technology, Arlington, TN), Salto-Talaris (Integra, Plainsboro, NJ), or the Scandinavian Total Ankle Replacement (STAR; Stryker, Kalamazoo, MI). We assessed the coronal tibiotalar angle on standardized weightbearing radiographs preoperatively, at one year, and at final follow-up. The visual analog scale (VAS) for pain, Short Form (SF)-36 scale, American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot-ankle scale, and Short Musculoskeletal Function Assessment (SMFA) scores were assessed preoperatively and at final follow-up. Subgroup analyses were performed to determine differences in outcome scores, deformity correction, and maintenance of alignment between patients with moderate (=10 degrees, <20 degrees) and severe (>20 degrees) preoperative deformity. Complication, reoperation, and revision rates were collected from chart review. Results: Mean preoperative valgus deformity was 15.5 ± 5.0 degrees, and was corrected to a mean 1.2 ± 2.6 degrees of valgus postoperatively (Figure; P<.001). An associated flatfoot deformity was present in 33% of patients, 65% of whom required concomitant procedures to address associated deformity. The VAS, SF-36, AOFAS, and SMFA scores improved significantly postoperatively (P<.001 for all), with no difference in amount of improvement between the moderate and severe deformity groups. Deformity correction was maintained at a mean 3.5 (range 2.0-5.9) years of follow-up, with no significant change in the mean tibiotalar angle between one year and final follow-up in either the moderate or severe deformity groups (P=.134 and P=.155, respectively). Reoperation and revision rates did not differ between the moderate and severe deformity groups. Conclusion: Correction of coronal alignment was achieved and maintained following TAA in patients with both moderate and severe preoperative valgus malalignment. Patients demonstrated significant improvement in patient-reported outcome scores regardless of amount of preoperative deformity. Additional procedures may be necessary at the time of TAA to balance the ankle and correct associated deformity in the foot.


2021 ◽  
pp. 193864002098092
Author(s):  
Devon W. Consul ◽  
Anson Chu ◽  
Travis M. Langan ◽  
Christopher F. Hyer ◽  
Gregory Berlet

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


2019 ◽  
Vol 40 (11) ◽  
pp. 1239-1248 ◽  
Author(s):  
James A. Nunley ◽  
Samuel B. Adams ◽  
Mark E. Easley ◽  
James K. DeOrio

Background: 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 long term for MB-TAR and at intermediate- to long-term follow-up for newer generation FB-TAR. Although comparisons between the 2 total ankle designs have been reported, to our knowledge, no investigation has compared the 2 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: 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 years, range 35-85 years) were enrolled; a demographic comparison between the 2 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 examination, 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, Short Form 36, Foot and Ankle Disability Index, Short Musculoskeletal Functional Assessment, and American Orthopaedic Foot & Ankle Society ankle-hindfoot score. Surgeries were performed by a nondesign team of orthopedic foot and ankle specialists with total ankle replacement expertise. Statistical analysis was performed by a qualified statistician. 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, 1 had died, 4 were withdrawn after enrolling but prior to surgery, and 4 were lost to follow-up. Results: In all outcome measures, the entire cohort demonstrated statistically significant improvements from preoperative evaluation to most recent follow-up with no statistically significant difference between the 2 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 FH-TAR, respectively. Reoperations were performed in 8 MB-TARs and 3 FH-TARs, with the majority of procedures being to relieve impingement or treat cysts and not to revise or remove metal implants. Conclusion: With a high level of evidence, our study found that patient-reported and clinical outcomes were favorable for both designs and that there was no significant difference in clinical improvement between the 2 implants. The incidence of lucency/cyst formation was similar for MB-TAR and FH-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 necessarily correlate with radiographic findings. Reoperations were more common for MB-TAR and, in most cases, were to relieve impingement or treat cysts rather than revise or remove metal implants. Level of Evidence: Level I, prospective randomized study.


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