Two to Five-Year Outcomes of Total Ankle Arthroplasty with the Infinity Fixed-Bearing Implant: A Concise Follow-up of a Previous Report.

LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

A Comparison of Fibula Pro-Tibia Fixation Versus Hindfoot Nailing for Unstable Fractures of the Ankle in Those Older Than 60 Years.

BACKGROUND: Ankle fractures in the elderly are an increasing problem, with poor outcomes reported. Operative options for patients with suspected osteoporosis and needing to bear weight to ambulate can include hindfoot intramedullary nail (IMN) or fibula pro-tibia fixation (FPT). FPT involves passing 2 or more screws through a lateral fibula plate, crossing the fibular into the tibia, with 1 or more screws proximal to the incisura. We compared the outcomes of these 2 techniques. METHOD: A retrospective review identified 68 patients aged over 60 years with unstable ankle fractures, treated with IMN or FPT. Primary outcome was surgical reoperation/revision rate, secondary outcomes included complications, length of stay, and functional status. Results: There were no significant differences in demographics between IMN and FPT. Revision rates were higher in IMN compared with FPT (P < .0001). IMN patients postoperatively had longer hospital stays (P = .02), longer follow-up times (P = .008), and higher rates of delayed wound healing (P = .03) and nonunion (P = .001). Multivariate analysis identified fixation and age to affect revision rates. CONCLUSION: Outcomes were worse in the IMN group compared with FPT. We believe both techniques have a role in the management of elderly ankle fractures, but patient selection is key. We suggest that FPT should be the first-choice technique when soft tissues permit. LEVELS OF EVIDENCE: Level III.

Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial.

BACKGROUND: End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF). OBJECTIVE: To determine which treatment is superior in terms of clinical scores and adverse events. DESIGN: A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307). SETTING: 17 National Health Service trusts across the United Kingdom. PATIENTS: Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure. INTERVENTION: Patients were randomly assigned to TAR or AF surgical treatment. MEASUREMENTS: The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible. RESULTS: Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]). LIMITATION: Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques. CONCLUSION: Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%. PRIMARY FUNDING SOURCE: National Institute for Health and Care Research Heath Technology Assessment Programme.

Subtalar Arthrodesis Union Rates With and Without Adjacent Ankle Arthrodesis.

BACKGROUND: Subtalar arthrodesis is the surgical procedure commonly performed to treat subtalar arthritis. Subtalar arthrodesis may have a higher nonunion rate if there is a preexisting adjacent joint arthrodesis. The aim of this retrospective cohort study was to compare the subtalar arthrodesis union rate of patients with native tibiotalar joints to that of patients with prior tibiotalar arthrodesis. The secondary aim was to assess risk factors for nonunion. METHODS: A retrospective cohort study of consecutive patients that underwent a subtalar arthrodesis in a single center between 2010 and 2020. The primary outcome of union was determined based on bridging callus on radiographs and clinical symptoms. If there was uncertainty, then a nonweightbearing CT was acquired. Chi-squared test and Mann-Whitney tests compared differences in demographics and risk factors for nonunion between groups. A logistical regression model was performed to determine risk factors for nonunion. RESULTS: Eighteen patients had an adjacent ankle arthrodesis and 53 patients did not. The successful subtalar arthrodesis union rate in those with a preexisting ankle joint arthrodesis (44.4%) was approximately half that in those without an ankle joint arthrodesis (86.8%) (P < .001). On multivariate logistic regression, an adjacent ankle arthrodesis was the only significant risk factor for nonunion. The odds ratio of nonunion of the subtalar joint with an adjacent ankle arthrodesis present was 4.90 (95% CI 1.02-23.56) compared to a subtalar arthrodesis with a native ankle joint. In addition, 9.4% of patients without an ankle arthrodesis underwent a revision subtalar arthrodesis compared with 44.4% of those with an adjacent ankle arthrodesis (P = .001). CONCLUSION: In our study, we found that patients undergoing a subtalar arthrodesis with an adjacent ankle arthrodesis have a significantly increased risk of nonunion compared with those undergoing a subtalar arthrodesis with a native ankle. Patients with a previously fused ankle need counseling about the high risk of nonunion and potential additional surgery.

Avoidance of injury to the posterior neurovascular bundle during total ankle arthroplasty - A simple technical tip.

Iatrogenic nerve injury to the tibial nerve is a serious but avoidable complication of total ankle replacements and may be under-reported as it may go unrecognised or thought to be due to tarsal tunnel syndrome. The tibial nerve is particularly vulnerable during the saw cuts at the posteromedial corner without appropriate protection. Prior to drilling the tibial and talar pins of the adjustment block for the Infinity ankle replacement we perform a 2 cm incision behind the medial malleolus. The tibialis posterior tendon sheath is identified and incised. A periosteal elevator is used to develop a plane between the back of the tibia and the tibialis posterior tendon and then exchanged for a mini Hohmann retractor protecting the neurovascular bundle. This allows us to drill the pins and saw cuts safely. The Hohmann retractor can be felt at the tip of the saw blade providing reassurance that the blade is not too deep. Our technique has not previously been reported in the literature. It acts as a simple reproducible way of avoiding injury to structures at the back of the ankle joint.

A new classification for Freiberg's disease.

INTRODUCTION: Freiberg's osteochondrosis is an uncommon cause of foot pain. Following a national survey circulated by the British Foot and Ankle Society it was found that no classification is used to guide surgical treatment. This study aimed to create a simple, reproducible CT based classification to preoperatively plan whether an osteotomy is required. METHODS: A retrospective review of 24 CT scans of new Freiberg's diseasediagnoses over a 10 year period was conducted. These images were assigned a study number and anonymised. The scans were then reviewed in their entirety by three independent specialists who determined whether an osteotomy would be of benefit. The sagittal CT slice that displayed the widest portion of proximal articular margin of the proximal phalanx was identified and divided the articular surface into 2 zones - plantar and dorsal and this formed the basis for our classification. These sagittal slices were then reviewed independently by two surgeons to determine if patients had disease in one or both zones and re-reviewed two weeks later to assess intra-observer reliability. RESULTS: All 24 cases involved the second metatarsal. From reviewing the sagittal CT slices, it was felt that 18 patients were suitable for osteotomy and 6 were suitable for debridement +/- arthroplasty alone. The current classification demonstrated that 18 patients had disease confined to zone 1 only and the remaining patients had disease in both zones. Inter-observer reliability assessment had 95.8% agreement (Krippendorff's Alpha 0.897). Intra-observer reliability was 100%. Correlation of those observed to have isolated zone 1 disease and suitability for osteotomy was absolute (Pearson r = 1). CONCLUSION: Dividing the metatarsal head into two zones on the widest sagittal slice of the CT scan offers an easy reproducible way to preoperatively plan surgical treatment for Freiberg's osteochondrosis. Patients with isolated zone 1 disease should be suitable for an osteotomy.

Fibula nail fixation in ankle fractures with significant soft tissue compromise: a retrospective cohort study.

PURPOSE: Intramedullary fixation of lateral malleolar fractures has increased in popularity recently with the introduction of the fibula nail. It has been proposed as an alternative fixation method in fractures to minimise soft tissue injury. The aim of this study was to evaluate the clinical and patient-reported outcomes of those who had an ankle fracture with concurrent significant soft tissue damage, treated with a fibula nail. METHODS: Details of patients who were managed at our institution using a fibula nail were obtained from the trauma database. The Acumed Fibula Rod System (FRS) was used in all cases. Those who were less than 12 months following injury were excluded. Patients attended a follow-up clinic for measurement of range of movement, radiographs, and to complete MOX-FQ and EQ-5D questionnaires. RESULTS: Twenty patients were identified. Eleven attended for review in person, and a further eight completed questionnaires (questionnaire response rate 95%). The mean age was 59 years (range 19-91). Twelve fractures were open, all of which were initially managed using an external fixator. One patient developed deep infection necessitating fusion. The mean MOX-FQ and EQ-5D scores were 53.6 and 0.649, respectively, at a median of 40 months post-injury. The mean EQ-VAS was 70. The range of movement of the affected side was significantly less than the unaffected side (p < 0.001 on paired t-test). CONCLUSION: This study suggests that the FRS offers a reliable and acceptable alternative fixation technique for patients who have significant soft tissue injuries.

Comparison of Complication and Reoperation Rates for Minimally Invasive Versus Open Cheilectomy of the First Metatarsophalangeal Joint.

BACKGROUND: Dorsal cheilectomy of the first metatarsophalangeal joint is an accepted treatment to alleviate dorsal impingement, pain, and reduced dorsiflexion in hallux rigidus. Traditionally performed via an open incision, this procedure has more recently been performed using minimally invasive techniques despite limited supportive published evidence. METHODS: From December 2012 through December 2017, a retrospective analysis of all cheilectomies performed in our institution was done. The surgical technique was recorded along with any subsequent procedures performed for either persistent or recurrent pain, and complications were also noted. A comparison between open and minimally invasive outcomes was performed. In total, 171 cheilectomies were performed during this period. There were 38 open and 133 minimally invasive procedures. RESULTS: At a mean 3-year follow-up, the reoperation rates of the 2 groups were different with only 1 (2.6%) of the open group requiring a fusion, while 17 (12.8%) of the minimally invasive surgical (MIS) group required further surgery (relative risk, 4.86; P = .059). In the open group, there was 1 (2.6%) complication, compared with 15 (11.3%) in the minimally invasive group (relative risk, 4.29; P = .076). CONCLUSION: While patients may opt for MIS cheilectomy with a proposed faster recovery time and better cosmesis, they should be counseled about the risks and benefits of both methods, and that the technique of MIS cheilectomy utilized in this study appears to have an increased relative risk of requiring a further procedure. LEVEL OF EVIDENCE: Level III, retrospective comparative series.

Competence-Based Curricula in the Context of Bologna and EU Higher Education Policy.

At the turn of the century European higher education policy became twin-track. The Bologna Process was launched and ran alongside developments in European legislation. Both tracks displayed a preoccupation with competences, in relation both to citizenship and to labour market needs. Scrutiny of important policy texts (Key Competences, the European Qualifications Framework, ECTS, the Bologna three-cycle degree structure) shows that 'competence' has never been given a precise and secure definition. Only very recently has the term entered the discourse of EU legislation on the recognition of professional qualifications. Current work on competence-based curricula in sectoral professions, including pharmacy, has helped bring the two policy tracks into closer alignment. The examples of competences identified in specific professional contexts can assist EU and Bologna policy-makers as they confront future challenges.

Outcome following use of the Achillon jig for the repair of acutely ruptured Achilles tendons.

We report a series of 143 patients who underwent limited open Achilles tendon repair using the Achillon device at a mean follow-up of 25 months. All patients attending our institution with a diagnosis of acute Achilles tendon rupture were considered for operative repair using the Achillon jig unless they declined surgery or met the exclusion criteria. Following surgery patients were contacted and asked to complete an Achilles Tendon Rupture Score (ATRS). The clinical records were reviewed for evidence of complications, demographic information and evidence of re-rupture. Statistical analysis of subgroups including age at presentation, delay to surgery and patients with complications was carried out using the Kruskal Wallis non-parametric test. We report no re-ruptures at a mean of 25 months (minimum 12 months) following surgery. The mean ATRS score was 84/100 (range 15-100). There was no statistical significance between any of the subgroups analyzed. In conclusion, acute Achilles repair using the Achillon jig is safe, with a low re-rupture rate, excellent ATRS scores at a minimum of 12 months post-operatively and low complications. The incidence of sural nerve injury is much lower than published series of percutaneous Achilles tendon repair without the use of a jig.

Impact of light-exposure on the metabolite balance of transgenic potato tubers with modified glycoalkaloid biosynthesis.

Metabolite profiling (liquid chromatography-mass spectrometry (LC-MS) and gas chromatography (GC-MS)) was used to assess the impact of light on the composition of transgenic potato (Solanum tuberosum L. cv. Desirée) with reduced glycoalkaloid content via the down-regulation of the SGT1 gene. Transgenic tubers exhibited an almost complete knock-out of α-solanine production and light had little impact on its accumulation. Levels of α-chaconine increased significantly in the peel of both the control and transgenic lines when exposed to light, particularly in the transgenic line. Major differences in metabolite profiles existed between outer and inner tuber tissues, and between light and dark-treated tubers. Many of the light-induced changes are explicable in terms of pathways known to be affected by stress responses. The impact of transgenesis on profiles was much less than that of tissue type or light and most differences were explicable in terms of the modification to the glycoalkaloid pathway.

Modifying glycoalkaloid content in transgenic potato--Metabolome impacts.

Metabolite profiling has been used to assess the potential for unintended composition changes in potato (Solanum tuberosum L. cv. Desirée) tubers, which have been genetically modified (GM) to reduce glycoalkaloid content, via the independent down-regulation of three genes SGT1, SGT2 and SGT3 known to be involved in glycoalkaloid biosynthesis. Differences between the three groups of antisense lines and control lines were assessed using liquid chromatography-mass spectrometry (LC-MS) and gas chromatography (GC)-MS, and data analysed using principal component analysis and analysis of variance. Compared with the wild-type (WT) control, LC-MS revealed not only the expected changes in specific glycoalkaloid levels in the GM lines, but also significant changes in several other metabolites, some of which were explicable in terms of known pathways. Analysis of polar and non-polar metabolites by GC-MS revealed other significant (unintended) differences between SGT lines and the WT, but also between the WT control and other control lines used.

Impacts on the metabolome of down-regulating polyphenol oxidase in potato tubers.

Tubers of potato (Solanum tuberosum L. cv. Estima) genetically modified to reduce polyphenol oxidase (PPO) activity and enzymatic discolouration were assessed for changes in the metabolome using Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography (GC)-MS. Metabolome changes induced over a 48 hour (h) period by tuber wounding (sliced transverse sections) were also assessed using two PPO antisense lines (asPPO) and a wild-type (WT) control. Data were analysed using Principal Components Analysis and Analysis of Variance to assess differences between genotypes and temporal changes post-tuber wounding (by slicing). The levels of 15 metabolites (out of a total of 134 that were detected) differed between the WT and asPPO lines in mature tubers at harvest. A considerably higher number (63) of these metabolites changed significantly over a 48 h period following tuber wounding. For individual metabolites the magnitude of the differences between the WT and asPPO lines at harvest were small compared with the impacts of tuber wounding on metabolite levels. Some of the observed metabolite changes are explicable in terms of pathways known to be affected by wound responses. Whilst some statistically significant interactions (11 metabolites) were observed between line and time after wounding, very few profiles were consistent when comparing the WT with both asPPO lines, and the underlying metabolites appeared to be random in terms of the pathways they occupy. Overall, mechanical damage to tubers has a considerably greater impact on the metabolite profile than any potential unintended effects resulting from the down-regulation of PPO gene expression.

DTREEv2, a computer-based support system for the risk assessment of genetically modified plants.

Risk assessment of genetically modified organisms (GMOs) remains a contentious area and a major factor influencing the adoption of agricultural biotech. Methodologically, in many countries, risk assessment is conducted by expert committees with little or no recourse to databases and expert systems that can facilitate the risk assessment process. In this paper we describe DTREEv2, a computer-based decision support system for the identification of hazards related to the introduction of GM-crops into the environment. DTREEv2 structures hazard identification and evaluation by means of an Event-Tree type of analysis. The system produces an output flagging identified hazards and potential risks. It is intended to be used for the preparation and evaluation of biosafety dossiers and, as such, its usefulness extends to researchers, risk assessors and regulators in government and industry.

New EU legislation for risk assessment of GM food: no scientific justification for mandatory animal feeding trials.

This commentary focuses on the potential added value of and need for (sub)-chronic testing of whole genetically modified (GM) foods in rodents to assess their safety. Such routine testing should not be required since, due to apparent weaknesses in the approach, it does not add to current risk assessment of GM foods. Moreover, the demand for routine testing using animals is in conflict with the European Union (EU) Commission's efforts to reduce animal experimentation. Regulating agencies in the EU are invited to respect the sound scientific principles applied to the risk assessment of foods derived from GM plants and not to interfere in the risk assessment by introducing extra requirements based on pseudo-scientific or political considerations.

Site-directed nucleases: a paradigm shift in predictable, knowledge-based plant breeding.

Conventional plant breeding exploits existing genetic variability and introduces new variability by mutagenesis. This has proven highly successful in securing food supplies for an ever-growing human population. The use of genetically modified plants is a complementary approach but all plant breeding techniques have limitations. Here, we discuss how the recent evolution of targeted mutagenesis and DNA insertion techniques based on tailor-made site-directed nucleases (SDNs) provides opportunities to overcome such limitations. Plant breeding companies are exploiting SDNs to develop a new generation of crops with new and improved traits. Nevertheless, some technical limitations as well as significant uncertainties on the regulatory status of SDNs may challenge their use for commercial plant breeding.

Comparative regulatory approaches for groups of new plant breeding techniques.

This manuscript provides insights into ongoing debates on the regulatory issues surrounding groups of biotechnology-driven 'New Plant Breeding Techniques' (NPBTs). It presents the outcomes of preliminary discussions and in some cases the initial decisions taken by regulators in the following countries: Argentina, Australia, Canada, EU, Japan, South Africa and USA. In the light of these discussions we suggest in this manuscript a structured approach to make the evaluation more consistent and efficient. The issue appears to be complex as these groups of new technologies vary widely in both the technologies deployed and their impact on heritable changes in the plant genome. An added complication is that the legislation, definitions and regulatory approaches for biotechnology-derived crops differ significantly between these countries. There are therefore concerns that this situation will lead to non-harmonised regulatory approaches and asynchronous development and marketing of such crops resulting in trade disruptions.

Compositional and toxicological analysis of a GM potato line with reduced α-solanine content--a 90-day feeding study in the Syrian Golden hamster.

Steroidal glycoalkaloids (GAs) are toxins, produced by plants of the Solanaceae family. The potato plant (Solanum tuberosum L.) and its tubers predominantly contain the two GAs α-chaconine and α-solanine. These compounds are believed to act in synergy, and the degree of toxicity may therefore depend on their ratio in the potato. To determine the influence of α-solanine: α-chaconine ratio in potatoes on toxicity, a GM potato line (SGT 9-2) with reduced α-solanine content, and the parental control line (Desirée wild-type) having a traditional α-solanine: α-chaconine ratio were (1) studied for compositional similarity by analysing for a range of potato constituents, and (2) used in a 90-day feeding trial with the Syrian Golden hamster to study differential toxicity. The animal feeding study used diets with up to 60% freeze-dried potato powder from either line. Whilst data indicated some compositional differences between the GM line and its wildtype control these did not raise concerns related to nutritional value or safety. Results of the feeding trials showed a low number of significant differences between potato lines with different α-solanine: α-chaconine ratio but none were considered to raise safety concerns with regard to human (or animal) consumption.