Comparison of Intermediate-Term Outcomes of Total Ankle Arthroplasty in Patients Younger and Older Than 55 Years

2019 ◽  
Vol 40 (7) ◽  
pp. 762-768 ◽  
Author(s):  
Gun-Woo Lee ◽  
Jong‑Keun Seon ◽  
Nack-Sung Kim ◽  
Keun-Bae Lee

Background: Total ankle arthroplasty is often not recommended to younger patients with ankle arthritis because of their high functional demands. The purpose of this study was to compare intermediate-term clinical and radiographic outcomes and survivorship rates of total ankle arthroplasty between patients younger and older than 55 years. Methods: A total of 117 consecutive patients (123 ankles) who underwent primary total ankle arthroplasty using Hintegra prosthesis with a mean follow-up of 78 months were enrolled and divided into 2 age groups: under 55 years (38 ankles; mean age 45 years) and over 55 years (85 ankles; mean age 65 years). Results: Clinical scores of Ankle Osteoarthritis Scale pain and disability, American Orthopaedic Foot & Ankle Society ankle-hindfoot, Short Form–36 Physical Component Summary and Mental Component Summary, and visual analog scale were not significantly different between the 2 age groups at the final follow-up ( P > .05). There were no significant differences in complications and survivorship rates between the two at a mean follow-up of 78 months ( P > .05). Conclusions: Clinical and radiographic outcomes and survival rates of total ankle arthroplasty in patients under age of 55 years were satisfactory and comparable to those in patients older than 55 years in the intermediate-term follow-up. Therefore, total ankle arthroplasty may be considered as a viable treatment option in young patients with end-stage ankle arthritis. Level of Evidence: Level III, comparative series, therapeutic.

2019 ◽  
Vol 40 (11) ◽  
pp. 1273-1281 ◽  
Author(s):  
Gun-Woo Lee ◽  
Asep Santoso ◽  
Keun-Bae Lee

Background: Ankle ligamentous injuries without fracture can result in end-stage ligamentous post-traumatic osteoarthritis, which may cause ligamentous imbalance after total ankle arthroplasty (TAA). However, outcomes of TAA in these patients are not well known. The purpose of this study was to evaluate intermediate-term clinical and radiographic outcomes of TAA in patients with ligamentous post-traumatic osteoarthritis and compare them with results of TAA for patients with primary osteoarthritis. Methods: We enrolled 114 patients (119 ankles) with consecutive primary TAA using HINTEGRA prosthesis at a mean follow-up duration of 6.0 years (range, 3-13). We divided all patients into 2 groups according to the etiology of osteoarthritis: (1) primary osteoarthritis group (69 ankles) and (2) ligamentous post-traumatic osteoarthritis group (50 ankles). Results: There was no significant intergroup difference in mean Ankle Osteoarthritis Scale (AOS), American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score, Short Form-36 Physical Component Summary, visual analog scale pain score, ankle range of motion, or complications at the final follow-up. However, the final tibiotalar angle was less corrected to 4.2 degrees in the ligamentous post-traumatic osteoarthritis group compared to 2.7 degrees in the primary osteoarthritis group ( P = .001). More concomitant procedures were required at the index surgery for the ligamentous post-traumatic osteoarthritis group ( P = .001). The estimated 5-year survivorship was 93.4% (primary osteoarthritis group: 91.3%; ligamentous post-traumatic osteoarthritis group: 95.8%). Conclusions: Clinical outcomes, complication rate, and 5-year survivorship of TAA in ankles with primary and ligamentous post-traumatic osteoarthritis were comparable with intermediate-term follow-up. Our results suggest that TAA would be a reliable treatment in ankles with ligamentous post-traumatic osteoarthritis when neutrally aligned stable ankles are achieved postoperatively. Level of Evidence: Level III, retrospective cohort study.


2018 ◽  
Vol 40 (1) ◽  
pp. 24-33 ◽  
Author(s):  
Federico G. Usuelli ◽  
Camilla Maccario ◽  
Francesco Granata ◽  
Cristian Indino ◽  
Venus Vakhshori ◽  
...  

Background: Ankle arthritis is a highly limiting pathology that causes pain and functional limitation with subsequent deterioration of quality of life. With recent advances in surgical instrumentation and techniques, prosthetic replacement of the ankle has proven to be a valid alternative to arthrodesis with comparable outcomes. The purpose of this study was to evaluate clinical and radiological findings in a transfibular total ankle replacement with follow-up of at least 2 years. Methods: This prospective study included 89 patients who underwent transfibular total ankle arthroplasty from May 2013 to February 2016. The mean age was 53.2 ± 13.5 years. All patients were followed for at least 24 months postoperatively with an average follow-up of 42.0 ± 23.5 months. Patients were assessed clinically and radiographically preoperatively and at 6, 12, and 24 months postoperatively. Results: At 24 months postoperatively, patients demonstrated statistically significant improvement in the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle Hindfoot Score from 33.8 ± 14.3 to 88.5 ± 6.6 ( P < .001), visual analog scale (VAS) from 80.5 ± 17.0 to 14.1 ± 9.2 ( P < .001), and Short Form-12 Physical and Mental Composite Scores from 29.9 ± 6.7 and 43.3 ± 8.6 to 47.0 ± 7.6 and 53.3 ± 8.1, respectively ( P < .001). In addition, ankle dorsiflexion and plantarflexion improved from 6.2 ± 5.5 and 9.6 ± 5.8 degrees to 24.2 ± 7.9 and 18.1 ± 7.6 degrees, respectively ( P < .001). Radiographically, patients demonstrated maintained neutral alignment of the ankle at 24 months. No patient demonstrated any radiographic evidence of tibial or talar lucency at final follow-up. Seven patients underwent reoperation for removal of symptomatic hardware (6 fibular plates, 1 syndesmotic screw); 2 patients experienced delayed wound healing. The first one was treated with plate removal and flap coverage. The second one required fibular plate removal. One patient developed a postoperative prosthetic infection requiring operative debridement, removal of implants, and placement of an antibiotic spacer. Conclusion: This study found that transfibular total ankle replacement was a safe and effective option for patients with ankle arthritis resulting in improvements in patient-reported outcomes, range of motion, and radiographic parameters. However, further studies are required to determine the mid- and long-term performance of these implants. Level of Evidence: Level IV, case series.


2020 ◽  
Vol 41 (12) ◽  
pp. 1510-1518
Author(s):  
Steve B. Behrens ◽  
Todd A. Irwin ◽  
Thomas B. Bemenderfer ◽  
Oliver N. Schipper ◽  
Susan M. Odum ◽  
...  

Background: Treatment of failed total ankle arthroplasty (TAA) is challenging. Limited literature is available on options and outcomes of revision arthroplasty despite failure rates ranging from 10% to 23% within 10 years after primary TAA. This study reports the clinical and radiographic outcomes of revision TAA using a fixed-bearing, intramedullary-referencing implant. Methods: A retrospective review was performed of 18 consecutive revision TAA cases between 2008-2015 using an intramedullary-referencing, fixed-bearing, 2-component total ankle system. Demographic and radiographic data were collected preoperatively, immediately postoperatively, and at the most recent follow-up. Functional outcome data were collected immediately postoperatively and at mean follow-up 47.5 months. Results: Eighteen patients underwent revision TAA, with 77.8% (14/18) implant survival. Index revision was performed most commonly for aseptic talar subsidence (55.6%) or implant loosening (tibia, 29.4%; talus, 58.9%). Following revision, 22.2% (4/18) patients required reoperation at a mean 57.3 (39-86) months. Osteolysis of the tibia, talus, and fibula was present preoperatively in 66.7% (12/18), 38.9% (7/18), and 38.9% (7/18) of patients, respectively, with progression of osteolysis in 27.8% (5/18), 11.1% (2/18) and 11.1% (2/18) of patients, respectively. Subsidence of the tibial and talar revision components was observed in 38.9% (7/18) and 55.6% (10/18) of patients, respectively. The median American Orthopaedic Foot & Ankle Society (AOFAS) score was 74.5 (26-100) and Foot Function Index (FFI) score 10.2 (0-50.4). Conclusion: Early results of intramedullary-referencing revision TAA demonstrated good patient-reported outcomes with maintenance of radiographic parameters at mean follow-up of 47.5 months. Aseptic talar subsidence or loosening were the main postoperative causes of reoperation. Revision arthroplasty utilizing an intramedullary-referencing implant was a viable option for the failed TAA. Level of Evidence: Level IV, case series.


2018 ◽  
Vol 39 (7) ◽  
pp. 787-794 ◽  
Author(s):  
Guilherme H. Saito ◽  
Austin E. Sanders ◽  
Cesar de Cesar Netto ◽  
Martin J. O’Malley ◽  
Scott J. Ellis ◽  
...  

Background: With the increasing use of total ankle arthroplasty (TAA), new implants with varied configurations are being developed every year. This study aimed to assess the early complications, reoperations, and radiographic and clinical outcomes of the Infinity TAA. To date, clinical results of this novel implant have not been published. Methods: A retrospective analysis of 64 consecutive ankles that underwent a primary Infinity TAA from July 2014 to April 2016 was performed. Patients had an average follow-up of 24.5 (range, 18-39) months. Medical records were reviewed to determine the incidence of complications, reoperations, and revisions. Radiographic outcomes included preoperative and postoperative tibiotalar alignment, tibial implant positioning, the presence of periprosthetic radiolucency and cysts, and evidence of subsidence or loosening. Additionally, patient-reported outcomes were analyzed with the Foot and Ankle Outcome Score (FAOS). Results: Survivorship of the implant was 95.3%. Fourteen ankles (21.8%) presented a total of 17 complications. A total of 12 reoperations were necessary in 11 ankles (17.1%). Revision surgery was indicated for 3 ankles (4.7%) as a result of subsidence of the implant. Tibiotalar coronal deformity was significantly improved after surgery ( P < .0001) and maintained during latest follow-up ( P = .81). Periprosthetic radiolucent lines were observed around the tibial component in 20 ankles (31%) and around the talar component in 2 ankles (3.1%). A tibial cyst was observed in 1 ankle (1.5%). Outcome scores were significantly improved for all FAOS components analyzed ( P < .0001), from 39.0 to 83.3 for pain, from 34.0 to 65.2 for symptoms, from 52.3 to 87.5 for activities of daily living, and from 15.7 to 64.2 for quality of life. Conclusion: Most complications observed in the study were minor and successfully treated with a single reoperation procedure or nonoperatively. Failures and radiographic abnormalities were most commonly related to the tibial implant. Further studies with longer follow-up are needed to evaluate the survivorship of the tibial implant in the long term. Level of evidence: Level IV, retrospective case series.


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0001
Author(s):  
James W. Brodsky ◽  
Justin M. Kane ◽  
Andrew W. Pao ◽  
David D. Vier ◽  
Scott Coleman ◽  
...  

Category: Ankle, Ankle Arthritis Introduction/Purpose: Operative treatment of end-stage ankle arthritis involves either ankle arthrodesis (AA) or total ankle arthroplasty (TAA). The theoretical benefit of TAA is the ability to preserve range of motion (ROM) at the tibiotalar joint. Previous studies have questioned whether it is justified to perform TAA over AA in stiff, arthritic ankles. However, a recent study showed that patients who underwent TAA with stiff ankles preoperatively experienced significant clinical improvement in range of motion and gait function compared to more flexible groups at 1-year follow-up. We retrospectively assessed these same gait and functional parameters to see if these improvements held up in long-term follow-up. Methods: A retrospective study of long-term, prospectively collected functional gait data in 33 TAA patients at a mean of 7.6 years postoperatively (range 4.8-13.3) used a multivariate regression model to determine the effect of ankle stiffness on the long- term, objective outcomes of TAA. Data was analyzed by quartiles (Q1, Q2+Q3, Q4) of preoperative sagittal ROM using one-way analysis of variance (ANOVA) to compare both preop and postop gait parameters. The two middle quartiles were combined to conform to distribution of the data. The multivariate analysis determined the independent effect of age, gender, BMI, years post- surgery, and preop ROM on every preop and postop parameter of gait. Results: Statistically significant differences were found in all three gait parameter categories, including temporal-spatial (step length and walking speed), kinematic (total sagittal ROM and maximum plantarflexion), and kinetic (peak ankle power). The stiffest ankles preoperatively (Q1) had the greatest absolute increase in total sagittal ROM postoperatively, +5.3o, compared to -1.3o (p<0.0174) in Q4 (most flexible). However, Q1 had the lowest absolute total postoperative sagittal ROM of 13.1 o, compared to 19.7 o (p<0.0108) in Q4. Q1 also had the lowest preoperative step length, walking speed, maximal plantarflexion, and peak ankle power when compared to the other subgroups. There was no difference in any of these same parameters postoperatively. BMI and years post-surgery had no effect on outcomes, while age and gender had a minimal effect. Conclusion: Preoperative range of motion was once again predictive of overall postoperative gait function in long-term follow-up at an average of 7.2 years. A greater degree of preoperative sagittal range of motion was predictive of greater postoperative sagittal range of motion in long-term follow-up. Patients with the stiffest ankles preoperatively once again had a statistically and clinically greater improvement in function as measured by multiple parameters of gait. This shows that the clinically meaningful improvement in gait function after total ankle arthroplasty holds up in long-term follow-up, even in the setting of limited preoperative sagittal range of motion.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0051
Author(s):  
Stephen White ◽  
Bruce Cohen ◽  
Carroll Jones ◽  
Michael Le ◽  
W. Hodges Davis

Category: Ankle Arthritis Introduction/Purpose: Ankle arthrodesis remains a prominent treatment choice for ankle arthritis in a majority of patients. Long term studies have shown a compensatory development of ipsilateral adjacent joint arthritis after ankle arthrodesis, and some patients who receive an ankle arthrodesis develop pain in surrounding joints, or even at the fusion site. As total ankle arthroplasty (TAA) design, instrumentation, and techniques have improved, the use of total ankle arthroplasty has become more widespread. Very few studies have been published on conversion of ankle arthrodesis to ankle arthroplasty, but they have shown improved function and patient-related outcome scores. The purpose of this study was to assess the radiographic, clinical, and patient-reported outcomes of patients undergoing ankle arthroplasty after conversion from a CT-confirmed ankle arthrodesis. Methods: This was a retrospective cohort study of patients with previous CT-confirmed ankle arthrodesis who underwent conversion to total ankle arthroplasty. Minimum follow up was 1 year. Nonunions of ankle arthrodesis were excluded. AOFAS ankle-hindfoot score, foot function index (FFI), pain, revision surgeries, complications, and patient demographics were assessed. Radiographs prior to TAA, and at latest follow-up were also reviewed. Results: 10 patients were included in the study with an average age of 54.5 years. No implants had to be revised. 1/10 (10%) patients had to undergo secondary surgery for heterotopic ossification removal. The same patient had to undergo another subsequent surgery for posterior ankle decompression. 2/10 (20%) patients had a mild talar subsidence of the TAA at latest follow-up, with no patients having tibial subsidence. Talar osteolysis was noticed in 2 patients (20%) at latest follow-up, with no patients having tibial osteolysis. Only one patient (10%) was noted to have a mild valgus alignment of TAA with no varus malalignments. All radiographic changes noted were clinically asymptomatic. The average AOFAS total score was 58 (range 23,89). The mean FFI total score was 41.9 (range 0,90). Conclusion: Conversion of ankle fusion to TAA is a challenging operation but can be a viable option for patients with ongoing pain after an ankle arthrodesis. We noted low revision rates and few complications at 1 year.


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.


2019 ◽  
Vol 40 (9) ◽  
pp. 1037-1042
Author(s):  
Koichiro Yano ◽  
Katsunori Ikari ◽  
Ken Okazaki

Background: Ankle disorders in patients with rheumatoid arthritis (RA) reduce their quality of life and activities of daily living. The aim of this study was to evaluate the midterm clinical and radiographic outcomes of TAA in patients with RA. Methods: This retrospective study included patients with a minimum follow-up of 2 years. A total of 37 RA patients (39 ankles) were enrolled in this study from August 2006 to March 2016. All the patients had undergone primary cemented mobile-bearing total ankle arthroplasty (TAA). Nine ankles received arthrodesis of the subtalar joint simultaneously. Patient-reported outcomes were measured preoperatively and at the latest follow-up by Self-Administered Foot-Evaluation Questionnaire (SAFE-Q). Radiographs of the ankle were analyzed preoperatively and at all follow-up visits to measure the periprosthetic radiolucent line, migration of the tibial component, and the subsidence of the talar component. Intraoperative and postoperative complications were recorded. The average duration of follow-up for the entire cohort was 5.0 ± 2.0 years (range 2.1-10.1 years). Results: All subscales of the SAFE-Q had improved significantly at the latest follow-up. No significant difference was found between the range of motion of the ankle before and after the surgery. Radiolucent lines were observed in 28 (73.7%) ankles. Migration of the tibial component and subsidence of the talar component were found in 8 (21.1%) and 11 (28.9%) ankles, respectively. Intraoperative malleolus fractures occurred in 3 (7.7%) ankles and delayed wound healing in 10 (25.6%) ankles. Four ankles were removed because of deep infection or noninfective loosening, resulting in an implant survival rate of 88.4% (95% CI, 0.76-1.0) at 10 years. Conclusion: The midterm patient-reported outcomes and implant retention rate after cemented mobile-bearing TAA for RA patients were satisfactory. However, a low radiographic implant success rate was observed. Level of Evidence: Level IV, retrospective 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.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0018
Author(s):  
Jonathan Day ◽  
Jaeyoung Kim ◽  
Andrew R. Roney ◽  
Jonathan H. Garfinkel ◽  
Scott J. Ellis ◽  
...  

Category: Ankle Arthritis; Ankle Introduction/Purpose: Total ankle arthroplasty (TAA) has garnered significant interest and increased use over the past decade, with advancements made in both design and surgical technique. The main advantage of TAA for the surgical treatment of ankle arthritis is to preserve range of motion compared to ankle arthrodesis. Among the criteria guiding the choice between arthroplasty and arthrodesis, the long-term survival and postoperative outcomes are of crucial importance. The Salto Talaris is a fixed-bearing implant first approved in the US in 2006, and long-term survivorship data is limited. The purpose of this study is to determine minimum 5-year survivorship of the Salto Talaris prosthesis and causes of failure. In addition, we evaluate long-term radiographic and patient-reported outcomes. Methods: We retrospectively identified 86 prospectively followed patients from 2007 to 2014 who underwent TAA with the Salto Talaris prosthesis at our institution. Of these, 81 patients (84 feet) had a minimum follow-up of 5 years (mean, 7.1; range, 5 to 12). Mean age was 63.5 years (range, 42 to 82) and mean BMI was 28.1 (range, 17.9 to 41.2). Survivorship was determined by incidence of revision, defined as removal/exchange of a metal component. Chart review was performed to record incidences of revision and reoperation. Preoperative, immediate and minimum 5-year postoperative x-rays were reviewed; coronal tibiotalar alignment (TTA) was measured on standing AP radiographs to assess alignment of the prosthesis. A TTA of +-5° from 90° indicated neutral alignment, while <85° and >95° was considered varus and valgus alignment, respectively. Radiographic subsidence as well as presence and location of periprosthetic cysts were documented. Pre- and minimum 5-year FAOS domains were compared. Results: Survivorship was 97.6% with two 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 19.5% (18) with the main reoperation being exostectomy with debridement for ankle impingement (12). Average preoperative TTA was 88.8° with 48 neutral (average TTA of 90.1°), 18 varus (82.3°) and 8 valgus (99.6°) ankles. Average postoperative TTA was 89.0° with 69 neutral (89.7°), 6 varus (83°), and 1 valgus ankle (99.3°). Radiographic subsidence was observed in one patient who underwent revision, and periprosthetic cysts were observed in 18 patients. There was significant improvement in all FAOS domains at final follow-up. Conclusion: This is the largest study to date dedicated to evaluating survivorship of the Salto Talaris prosthesis. Our data reflects a high survival rate and moderate reoperation rate with long-term follow-up of the Salto Talaris implant. We observed significant improvement in radiographic alignment as well as patient-reported clinical outcomes at minimum 5-year follow-up.


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