Total ankle replacement versus ankle arthrodesis for patients aged 50-85 years with end-stage ankle osteoarthritis: the TARVA RCT.

Background: We aimed to compare the clinical effectiveness, cost-effectiveness and complication rates of total ankle replacement with those of arthrodesis (i.e. ankle fusion) in the treatment of end-stage ankle osteoarthritis. Methods: This was a pragmatic, multicentre, parallel-group, non-blinded randomised controlled trial. Patients with end-stage ankle osteoarthritis who were aged 50-85 years and were suitable for both procedures were recruited from 17 UK hospitals and randomised using minimisation. The primary outcome was the change in the Manchester-Oxford Foot Questionnaire walking/standing domain scores between the preoperative baseline and 52 weeks post surgery. Results: Between March 2015 and January 2019, 303 participants were randomised using a minimisation algorithm: 152 to total ankle replacement and 151 to ankle fusion. At 52 weeks, the mean (standard deviation) Manchester-Oxford Foot Questionnaire walking/standing domain score was 31.4 (30.4) in the total ankle replacement arm (n = 136) and 36.8 (30.6) in the ankle fusion arm (n = 140); the adjusted difference in the change was -5.6 (95% confidence interval -12.5 to 1.4; p = 0.12) in the intention-to-treat analysis. By week 52, one patient in the total ankle replacement arm required revision. Rates of wound-healing issues (13.4% vs. 5.7%) and nerve injuries (4.2% vs. < 1%) were higher and the rate of thromboembolic events was lower (2.9% vs. 4.9%) in the total ankle replacement arm than in the ankle fusion arm. The bone non-union rate (based on plain radiographs) in the ankle fusion arm was 12.1%, but only 7.1% of patients had symptoms. A post hoc analysis of fixed-bearing total ankle replacement showed a statistically significant improvement over ankle fusion in Manchester-Oxford Foot Questionnaire walking/standing domain score (-11.1, 95% confidence interval -19.3 to -2.9; p = 0.008). We estimate a 69% likelihood that total ankle replacement is cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over the patient's lifetime. Limitations: This initial report contains only 52-week data, which must therefore be interpreted with caution. In addition, the pragmatic nature of the study means that there was heterogeneity between surgical implants and techniques. The trial was run across 17 NHS centres to ensure that decision-making streams reflected the standard of care in the NHS as closely as possible. Conclusions: Both total ankle replacement and ankle fusion improved patients' quality of life at 1 year, and both appear to be safe. When total ankle replacement was compared with ankle fusion overall, we were unable to show a statistically significant difference between the two arms in terms of our primary outcome measure. The total ankle replacement versus ankle arthrodesis (TARVA) trial is inconclusive in terms of superiority of total ankle replacement, as the 95% confidence interval for the adjusted treatment effect includes both a difference of zero and the minimal important difference of 12, but it can rule out the superiority of ankle fusion. A post hoc analysis comparing fixed-bearing total ankle replacement with ankle fusion showed a statistically significant improvement of total ankle replacement over ankle fusion in Manchester-Oxford Foot Questionnaire walking/standing domain score. Total ankle replacement appears to be cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over a patient's lifetime based on long-term economic modelling. Future work: We recommend long-term follow-up of this important cohort, in particular radiological and clinical progress. We also recommend studies to explore the sensitivity of clinical scores to detect clinically important differences between arms when both have already achieved a significant improvement from baseline. Trial registration: This trial is registered as ISRCTN60672307 and ClinicalTrials.gov NCT02128555. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 5. See the NIHR Journals Library website for further project information.

Each year, over 29,000 patients with ankle osteoarthritis seek a specialist opinion, of whom 4000 undergo NHS surgical treatment. The main surgical treatments for severe ankle osteoarthritis are total ankle replacement or arthrodesis (i.e. ankle fusion). Both are known to be good treatments to relieve pain, and each has its advantages. Total ankle replacement is a more popular patient choice than ankle fusion. When deciding whether to undergo ankle replacement or fusion, patients consult various sources, but the majority of them rely on the advice of their surgeon to make a final decision. To the best of our knowledge, there has never been a high-quality randomised clinical trial comparing these two treatments and there are no published guidelines on the most suitable management. In this study, 303 patients were randomised to a type of ankle surgery: 138 in the total ankle replacement arm and 144 in the ankle fusion arm received surgery. We found that both total ankle replacement and ankle fusion improved patients' walking ability, but we did not find a statistically significant difference between the treatment arms based on our primary outcome measure at 1 year. When we considered the type of total ankle replacement implant, we found that the implant most commonly used in the NHS (a fixed-bearing two-component implant) had better outcomes at 1 year than ankle fusion. Both total ankle replacement and ankle fusion appear to be safe. However, there were more wound-healing issues and nerve injuries in the total ankle replacement arm than in the ankle fusion arm. Twelve per cent of patients experienced bone non-union in the ankle fusion arm, but only 7.1% experienced symptoms. We estimate that there is a 69% chance that total ankle replacement would be cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over a patient's lifetime. This study provides the NHS with important information that could help to obtain the best possible outcome for patients with severe ankle arthritis.

Outcomes of Salvage Procedures for Failed Total Ankle Arthroplasty.

BACKGROUND: The number of total ankle arthroplasty (TAA) procedures increased rapidly in the last years and so have its complications. The main pillars in treating failed TAA are revision total ankle arthroplasty (RTAA), revision total ankle arthrodesis (RAA), or revision tibiotalocalcaneal fusion (RTTC). To evaluate these options, we compared clinical, radiologic, and patient-reported outcomes. METHODS: A single-center, retrospective review of 111 cases of revision procedures of failed TAA from 2006 to 2020 was performed. Patients undergoing polyethylene exchange and revision of one metallic component were excluded. Demographic data, failure, and survival rates were analyzed. The European Foot and Ankle Society (EFAS) score and radiographic changes in the subtalar joint were evaluated. The average follow-up was 67.89 ± 40.51 months. RESULTS: One hundred eleven patients underwent removal of TAA. The procedures included 40 revisions of both metallic components, 46 revision total ankle arthrodesis and 25 revision tibiotalocalcaneal fusion. The overall failure rate in the cohort was 5.41% (6/111). The failure rate after RAA was 4.35 times higher than that of RTAA, whereas RTTC did not show failures. RTAA and RTTC lead to a 1-year and 5-year survival rate of 100%. RAA resulted in a 1-year survival rate of 90% and a 5-year survival rate of 85%. The mean EFAS score in the cohort was 12.02 ± 5.83. Analysis of the EFAS score showed that RTTC provided the most reliable pain reduction, and RTAA achieved the best gait pattern. RAA resulted in poorer clinical results. Subtalar joint degeneration occurred significantly less in the RTAA group (P = .01). CONCLUSION: This retrospective study suggests lower failure rates, increased short-term survival and a better clinical outcomes of revision arthroplasty and tibiotalocalcaneal fusion than ankle arthrodesis. Revision arthroplasty is a promising solution in treating failed total ankle arthroplasty considering lower rate of subsequent adjacent joint degeneration. LEVEL OF EVIDENCE: Level III, non-randomized observational study.

Failure rates and patient-reported outcomes of revision of total ankle arthroplasty.

INTRODUCTION: Despite the increasing number of revision total ankle arthroplasty (TAA), the literature on indications, surgical options, and outcomes is limited. This study reports on failure rates and patient-reported outcomes (PROM) for a cohort of 122 patients who underwent revision of TAA. MATERIALS AND METHODS: A retrospective review of revision TAA between 2006 and 2020 was performed at one institution. Patient's demographics and different surgical procedures were analyzed with particular attention to comparing polyethylene exchange with revision of both metallic components and to additional interventions for axis correction. Failure rates and the European Foot and Ankle Society (EFAS) score were collected. The average follow-up period was 70.37 ± 46.76 months. RESULTS: 122 patients were treated with an exchange procedure. The surgery included 69 polyethylene exchanges, 12 revisions of one metallic component, and 41 revisions of both metallic components. The overall failure rate was 14.75%. The EFAS score, completed by 94 of the 122 patients, was used to evaluate clinical outcomes. Median EFAS score was 12.51 ± 5.53, and median EFAS sports score was 2.97 ± 3.04. Revision rates after polyethylene exchange were significantly higher than after exchanging both metallic components (p value = 0.03), while the EFAS score showed slightly better results in patients treated with polyethylene exchange. Adding procedures to induce axis correction led to significantly lower revision rates (p value = 0.03), and the EFAS score was also improved but without statistical significance. CONCLUSIONS: The high failure rate of polyethylene exchange indicates that the intervention does not address the actual cause of failed TAA in many cases. Additional axis correction should be considered more frequently. If the underlying issues of prosthesis failure can be identified and sufficiently addressed, the results of revision surgery are likely to improve.

LIM Homeobox Transcription Factor 1-ß Expression is Upregulated in Patients with Osteolysis after Total Ankle Arthroplasty and Inhibits Receptor Activator of Nuclear Factor-κB Ligand-Induced Osteoclast Differentiation in Vitro.

BACKGROUND: Osteolysis is one of the most common problems that occurs after total hip and knee arthroplasty and has recently become a significant problem after total ankle arthroplasty (TAA). In this study, we investigated the role of LIM homeobox transcription factor 1-ß (Lmx1b) in osteoclast differentiation. By evaluating the expression profiles associated with osteolysis following TAA treatment, Lmx1b was found to be differentially expressed in patients with osteolysis after TAA. METHODS: To identify the important genes associated with osteolysis after TAA, RNA sequencing was performed by analyzing 8 patient samples: 5 primary TAA samples (control group) and 3 TAA samples revised for flexion instability (osteolysis group). By analyzing the differentially expressed genes and gene ontologies, Lmx1b expression was found to be upregulated in the osteolysis group compared to that in the control group. Focusing on the role of Lmx1b in bone cells, Lmx1b was overexpressed by a retrovirus in osteoclast precursor cells. The cultured cells were stained with tartrate-resistant acid phosphatase, and the expression of osteoclast-related genes was analyzed using real-time polymerase chain reaction. RESULTS: Lmx1b overexpression in osteoclast precursors suppresses osteoclast formation and resorptive activity. The expression of osteoclast marker genes was significantly reduced during osteoclast differentiation by Lmx1b overexpression. Furthermore, Lmx1b is associated with nuclear factor of activated T cells 1 (NFATc1) and inhibited NFATc1 translocation into the nucleus. CONCLUSIONS: These results provide novel insights into the anti-bone resorptive effect of Lmx1b on osteolysis after TAA and may lead to the development of effective preventative and therapeutic strategies for peri-implant osteolysis.

Missed Tillaux Fracture and Syndesmosis Injury in Adult: Arthroscopic Assisted Reduction and Fixation.

Tillaux fractures are fractures of the lateral margin of the distal tibia, usually reported in children between 12 and 14 years old. As intraarticular fractures, they require anatomic reduction and fixation to avoid posttraumatic complications. Since the injury mechanism is external rotation of the foot on the leg, these injuries are commonly associated with other fractures or ligamentous lesions. Currently, arthroscopy is being increasingly used to assist and improve surgical treatment of ankle fractures. The authors describe a 12-month follow-up of a rare case of a missed Tillaux fracture associated with syndesmosis injury in a 76-year-old polytrauma patient, successfully treated by arthroscopically-assisted reduction and internal fixation.

Missed Tillaux Fracture and Syndesmosis Injury in Adult: Arthroscopic Assisted Reduction and Fixation / Fratura de Tillaux não percebida e lesão por sindesmose em adultos: Redução e fixação artroscópica assistida

Abstract Tillaux fractures are fractures of the lateral margin of the distal tibia, usually reported in children between 12 and 14 years old. As intraarticular fractures, they require anatomic reduction and fixation to avoid posttraumatic complications. Since the injury mechanism is external rotation of the foot on the leg, these injuries are commonly associated with other fractures or ligamentous lesions. Currently, arthroscopy is being increasingly used to assist and improve surgical treatment of ankle fractures. The authors describe a 12-month follow-up of a rare case of a missed Tillaux fracture associated with syndesmosis injury in a 76-year-old polytrauma patient, successfully treated by arthroscopically-assisted reduction and internal fixation.

Resumo As fraturas de Tillaux são fraturas da margem lateral da tíbia distal, geralmente relatadas em crianças entre 12 e 14 anos. Como fraturas intra-articulares, requerem redução e fixação anatômica para evitar complicações pós-traumáticas. Como o mecanismo de lesão é a rotação externa do pé na perna, essas lesões são comumente associadas a outras fraturas ou lesões ligamentares. Atualmente, a artroscopia está sendo cada vez mais utilizada para auxiliar e melhorar o tratamento cirúrgico das fraturas do tornozelo. Os autores descrevem um acompanhamento de 12 meses de um caso raro de uma fratura não percebida de Tillaux associada a lesão por sindesmose em um paciente de politrauma com 76 anos de idade, tratado com sucesso por redução e fixação interna assistida por artroscopia.

The short-term outcomes and rivision complication analysis of medial unicompartmental knee osteoarthritis treated by unicompartmental knee arthroplasty / 中国医师杂志

Objective To evaluate the short-term outcomes and analyze the complications of medial unicompartmental knee osteoarthritis (MUKOA) treated by unicompartmental knee arthroplasty (UKA).Methods Retrospectively analyzed the patients suffered with MUKOA and registered into our department from Jul 2015 to Jan 2017.71 cases were enrooled in the study,of which 17 are male (19 UKA) and 54 are female (66 UKA).The general information,perioperative data,Hospital for Special Surgery (HSS) score,visual analogue score (VAS) and complications of the group were analyzed.Results Females were three times more than males (54∶ 17).The average age of female subjects was lower than that of male,the difference was significant (P ＜ 0.05).The rate of Osteoporosis of females was significantly higher than that of males (P ＜ 0.05).The operative time,length of incision,total overt blood loss and postoperative in-bed time were (54.06 ± 6.24) min,(8.56 ± 0.83) cm,(86.10 ± 5.44) ml,(3.51 ± 1.01) d,respectively.No significant differences were found between males and females (P ＞ 0.05).The preoperative,3 months and 6 months postoperative HSS scores were 45.2 ± 4.5,80.3 ± 5.7 and 88.4 ± 4.2,respectively.No differences were found between males and females (P ＞ 0.05).The preoperative,3 months and 6 months postoperative VAS scores were 6.6 ± 1.2,1.7 ± 0.7 and 0.5 ± 0.5,respectively.No differences were found between males and females (P ＞ 0.05).There were 2 revised cases,and the reasons for revision were infection and unstability caused by sport injury.Conclusions UKA is an ideal choice for patients with MUKOA,Especially for the ones older than 60 years.However,the corrections on lower-limb forceline and joint unstability are limited,thus,the indications for UKA should be controlled strictly.

[Research progress on total ankle replacement].

Total ankle replacement (TAR) is considered as a treatment option for end stage ankle arthritis. This treatment was abandoned due to the early failure prosthesis in the past. However, with recently advancements in ankle prosthesis design and improved surgical techniques, TAR has made great progress and the indications are expanding. Many studies have shown acceptable mid term and long term results of TAR, and it is worth looking forward to the prospect. Advantages of TAR over arthrodesis include improvement in joint range of motion, better gait activity, and decreased incidence of adjacent joint arthritis. With the further development, TAR will be considered as gold standard for the treatment of end stage ankle arthritis instead of the ankle arthrodesis. However, there are still many problems of TAR need to be solved in this present stage of development, including higher economic costs, lower survival rate, and higher revision rate. Patients and surgeons should have confidence in TAR, also need to choose this treatment with careful consideration.

Research progress on total ankle replacement / 中国骨伤

Total ankle replacement (TAR) is considered as a treatment option for end stage ankle arthritis. This treatment was abandoned due to the early failure prosthesis in the past. However, with recently advancements in ankle prosthesis design and improved surgical techniques, TAR has made great progress and the indications are expanding. Many studies have shown acceptable mid term and long term results of TAR, and it is worth looking forward to the prospect. Advantages of TAR over arthrodesis include improvement in joint range of motion, better gait activity, and decreased incidence of adjacent joint arthritis. With the further development, TAR will be considered as gold standard for the treatment of end stage ankle arthritis instead of the ankle arthrodesis. However, there are still many problems of TAR need to be solved in this present stage of development, including higher economic costs, lower survival rate, and higher revision rate. Patients and surgeons should have confidence in TAR, also need to choose this treatment with careful consideration.

Intermediate and short-term clinical observation after treatment for bone diseases of ankle joint with Scandinavian total ankle replacement / 中华骨科杂志

Objective To evaluate results and demonstrate problems of Scandinavian total ankle replacement (STAR) in patients with ankle arthritis and clarify its role as a growing alternatives to ankle fusion.Methods Retrospectively analyzed 43 patients who had total ankle replacement from May 1999 to January 2013.All cases were evaluated with interview focusing on pain,daily activities and clinical and radiologic examinations.The average age of patients was 46 (range,35 to 56) years old.Among these cases,9 patients suffered from posttraumatic arthritis,25 osteoarthritis,5 rheumatoid arthritis and 4 avascular necrosis of the talar body.All patients complained about ankle joint pain and swelling as well as limited ROM of joint.Results Mean follow-up was 6.7 (1.5 to 12 years) years.37 cases had complete follow-up.The average preoperative ankle score was 27.0± 10.5,pain degree score was 16.5± 12.8,joint function score was 10.6±7.4,ROM score was 8.2±5.2.The average preoperative ankle score was 86.5±13.2,pain degree score was 49.5±4.5,joint function score was 19.7±9.5,ROM score was 19.2±3.2.The indicatiors compared with preoperative,postoperative differences have statistical significance.The score of postoperative Kofoed were divided into excellent 35 cases,good 1 case and poor 1 case,excellent and good rate was 97.3％.The American orthopaedic foot and ankle society (AOFAS) scoring system was improved from 40.5 preoperatively to 80.6 postoperatively.No postoperative loosening or migrating of the prosthesis was noted.Conclusion It was demonstrated that the standardized and normalized operative techniques as well as operative tools closely matched to the prosthesis could achieve favorable outcomes according to the clinical and radiographic outcomes and overall acceptable cornplication rates in the present study.STAR was a choice for the patients with advanced osteoarthritis,posttraumatic arthritis,rheumatic arthritis and avascular necrosis of the talar body.

Total ankle replacement for end-stage ankle arthritis: outcome and indications / 中华骨科杂志

Objective To explore the clinical results of total ankle replacements with the Scandinavian Total Ankle Replacement (STAR) prosthesis for end-stage ankle arthritis.Methods Data of 73 cases with end-stage ankle arthritis who received Scandinavian total ankle replacement from January 2005 to May 2013 were retrospectively analyzed.They were 34 males and 39 females,with an average age of 59.6 years old (range,37-76 years old),average body mass index (BMI) of 25.3 kg/m2 (range,21.8-28.0 kg/m2).All patients were classified into stage-3 arthritis according to Morrey-Wiedeman.Kofoed,American Orthopaedic Foot and Ankle Society (AOFAS) ankle and hindfoot score and visual analog scale (VAS) were used to evaluate the function of foot and ankle.Patients with a hindfoot deformity below 10° were compared with those who above 10°;and patients above 55 years old were compared with those who below it.Results 5 replacement failed (2 liner ruptured and received replacement;2 metal components displaced,1 received TTC fusion and the other underwent revision with inferior tibiofibular joint fusion,the last patient suffered from deep infection and received the STAR removal and secondary fusion) in 73,and the rest were followed up for 12 to 110 months (average,55.2 months).59 patients were satisfied with or without reservations.The satisfaction rate was 80.8％ (59/73).The pre-op values of AOFAS,Kofoed,VAS and range of motion (ROM) were 46.6±3.5,43.0±4.7,8.7±0.7,34.4°±7.1° and the post-op values were 86.6±4.3,82.6±4.6,3.0±1.0,45.1°±8.2° respectively,and all were significantly improved compared with before.The AOFAS,AOFAS Function and ROM values of patients below 55 years old were 86.1±3.8,47.0±2.7,45.7°±7.0°,and the same values of patients above 55 were 86.7±4.6,46.8±3.1,44.9°±8.8°.The AOFAS,AOFAS Function and ROM values of patients with above 10° coronal deformity were 86.1±4.7,47.0±2.7,43.0°±7.7°,and the same values of patients below 10° were 86.8±4.2,46.8±3.1,46.1°±8.2°.There was no difference between the groups.Conclusion The STAR is the preferable surgical treatment option in patients with end-stage ankle arthritis,showing high reliability and effectivity in pain relieving and function improvement.