Background:
We present our results with an INBONE I (Wright Medical, Memphis, TN) prosthesis that have a minimum of 4 to 10 years of follow-up and include a preoperative deformity analysis on ...outcomes.
Methods:
A consecutive series of 149 patients, from 2007 to 2011, at a single institution were enrolled. Pain and patient-reported function were assessed preoperatively and at yearly follow-ups. We analyzed the data for complications, reoperations, and failures (defined as undergoing revision for exchange or removal of one or both metallic components for any reason). Patients were also grouped according to coronal plane tibiotalar alignment; either ≥10 degrees or <10 degrees, and these outcomes were compared. Our follow-up ranged from 48 to 113 months (average 5.9 years).
Results:
There was significant improvement (P < .05) in the visual analog scale for pain, American Orthopaedic Foot & Ankle Society hindfoot scale, Short Musculoskeletal Function Assessment, and Short Form 36-Item Health Survey scores at most recent follow-up. There were 14 implant failures with overall survivorship of 90.6% (135/149). Reasons for failure included cysts/loosening (7), talar subsidence (4), fractured component (1), impingement pain (1), and infection (1). Seventy-two patients (48.3%) with preoperative coronal plane deformity of ≥10 degrees varus or valgus were compared to 78 patients (51.7%) with <10 degrees deformity. There was no difference in patient outcome scores or revision rates between these patient groups. There was a statistically significant difference (P = .039) in reoperation rates among patients with ≥10 degrees deformity (22.2%) compared to those without such a deformity (37.7%)
Conclusion:
Patients who underwent INBONE I fixed-bearing total ankle arthroplasty demonstrated significant improvement in outcomes at a mean of 5.9 years. Catastrophic talar component collapse did occur (2.7% of cases), but relatively rarely. The patients with preoperative coronal plane tibiotalar deformity had similar pain relief, function, and need for revision of implant components. Despite the presumed shortcomings of the INBONE I’s design, this implant showed promising results, with or without deformity, at midterm follow-up with survivorship of 90.6%.
Level of Evidence:
Level III, comparative study.
Background:
There is limited data evaluating the effect of obesity on outcomes following total ankle arthroplasty (TAA), especially in adequate sample sizes to detect impacts on patient-reported ...outcomes (PROs). The purpose of this study was to assess the effect of obesity on complication rates and PROs.
Methods:
This was a single-institution, retrospective study of 1093 primary TAA performed between 2001 and 2020. Minimum follow-up was 2 years. Patients were stratified by body mass index (BMI) into control (BMI = 18.5-29.9; n = 615), obesity class I (BMI = 30.0-34.9; n = 285), and obesity class II (BMI > 35.0; n = 193) groups. Patient information, intraoperative variables, postoperative complications, and PRO measures were compared between groups using univariable statistics. Multivariable Cox regression was performed to assess risk for implant failure. Mean follow-up was 5.6 years (SD: 3.1).
Results:
Compared to control and class I, class II patients had the lowest mean age (P = .001), highest mean ASA score (P < .001), and greatest proportion of female sex (P < .001) and Black/African American race (P = .005). There were no statistically significant differences in postoperative complications (infection, implant failure, or impingement) across the BMI classes (P > .05).
Preoperatively, class II had lower (worse) mean scores for Foot and Ankle Outcome Score pain and ADL subscales than controls (post hoc pairwise P < .001 for both). At final follow-up, both class II and class I had lower (worse) mean Short Musculoskeletal Function Assessment (post hoc pairwise P < .001 and P = .030, respectively) and 36-Item Short Form Health Survey scores (post hoc pairwise P < .001 and P = .005, respectively) than controls.
Conclusion:
At midterm follow-up, obesity was not associated with increased rates of complications after TAA. Patients with obesity reported worse musculoskeletal function and overall quality of life after TAA but there was no differential improvement in PROs across BMI classes. To our knowledge, this is the largest single-institution study to date examining the effect of obesity on outcomes after primary TAA.
Level of Evidence:
Level III, retrospective comparative study.
Although many patients with posttraumatic ankle arthritis are of a younger age, studies evaluating the impact of age on outcomes of primary total ankle arthroplasty (TAA) have revealed heterogenous ...results. The purpose of the present study was to determine the effect of age on complication rates and patient-reported outcomes after TAA.
We retrospectively reviewed the records of 1,115 patients who had undergone primary TAA. The patients were divided into 3 age cohorts: <55 years (n = 196), 55 to 70 years (n = 657), and >70 years (n = 262). Demographic characteristics, intraoperative variables, postoperative complications, and patient-reported outcome measures were compared among groups with use of univariable analyses. Competing-risk regression analysis with adjustment for patient and implant characteristics was performed to assess the risk of implant failure by age group. The mean duration of follow-up was 5.6 years.
Compared with the patients who were 55 to 70 years of age and >70 years of age, those who were <55 years of age had the highest rates of any reoperation (19.9%, 11.7%, and 6.5% for the <55, 55 to 70, and >70-year age groups, respectively; p < 0.001), implant failure (5.6%, 2.9%, and 1.1% for the <55, 55 to 70, and >70-year age groups, respectively; p = 0.019), and polyethylene exchange (7.7%, 4.3%, and 2.3% for the <55, 55 to 70, and >70-year age groups, respectively; p = 0.021). Competing-risk regression revealed a decreased risk of implant failure for patients who were >70 of age compared with those who were <55 years of age (hazard ratio HR, 0.21 95% confidence interval (CI), 0.05 to 0.80; p = 0.023) and for patients who were 55 to 70 years of age compared with those who were <55 years of age (HR, 0.35 95% CI, 0.16 to 0.77; p = 0.009). For all subscales of the Foot and Ankle Outcome Score (FAOS) measure except activities of daily living, patients who were <55 years of age reported the lowest (worst) mean preoperative and postoperative scores compared with those who were 55 to 70 years of age and >70 years of age (p ≤ 0.001). Patients who were <55 years of age had the highest mean numerical pain score at the time of the latest follow-up (23.6, 14.4, 12.9 for the <55, 55 to 70, and >70-year age groups, respectively; p < 0.001).
Studies involving large sample sizes with intermediate to long-term follow-up are critical to reveal age-related impacts on outcomes after TAA. In the present study, which we believe to be the largest single-institution series to date evaluating the effect of age on outcomes after TAA, younger patients had higher rates of complications and implant failure and fared worse on patient-reported outcome measures.
Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.
Background:
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. The goal of this study was 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 years up to 10 years’ follow-up. At the preoperative visit and 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 & 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, 1 year postoperatively, and at their most recent follow-up. Criteria for failure was defined as revision requiring exchange or removal of the metallic components for any reason. We identified 106 patients having a Salto Talaris total ankle replacement. Seventy-two patients (mean age, 61.9 years) met the minimum requirement for follow-up (range 60-115 months, mean 81.1 months).
Results:
Significant improvements were seen in the VAS, SMFA, AOFAS score, and SF-36 from preoperatively to their final follow-up (P < .001). Survivorship was 95.8% for those with at least 5-year follow-up, with 2 patients undergoing revision arthroplasty for aseptic loosening and a third patient scheduled for revision for a chronic wound infection. Fourteen patients (19%) required an additional surgery for a total of 17 additional operative procedures on the ipsilateral ankle or hindfoot.
Conclusion:
Patients undergoing total ankle arthroplasty with the Salto Talaris prosthesis continued to show significant improvements in pain and functional outcomes at midterm follow-up. This prosthesis has shown to be an effective treatment option with durable results.
Level of Evidence:
Level IV, therapeutic, case series.
IMPORTANCE: The natriuretic peptides are biochemical markers of heart failure (HF) severity and predictors of adverse outcomes. Smaller studies have evaluated adjusting HF therapy based on ...natriuretic peptide levels (“guided therapy”) with inconsistent results. OBJECTIVE: To determine whether an amino-terminal pro–B-type natriuretic peptide (NT-proBNP)–guided treatment strategy improves clinical outcomes vs usual care in high-risk patients with HF and reduced ejection fraction (HFrEF). DESIGN, SETTINGS, AND PARTICIPANTS: The Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was a randomized multicenter clinical trial conducted between January 16, 2013, and September 20, 2016, at 45 clinical sites in the United States and Canada. This study planned to randomize 1100 patients with HFrEF (ejection fraction ≤40%), elevated natriuretic peptide levels within the prior 30 days, and a history of a prior HF event (HF hospitalization or equivalent) to either an NT-proBNP–guided strategy or usual care. INTERVENTIONS: Patients were randomized to either an NT-proBNP–guided strategy or usual care. Patients randomized to the guided strategy (n = 446) had HF therapy titrated with the goal of achieving a target NT-proBNP of less than 1000 pg/mL. Patients randomized to usual care (n = 448) had HF care in accordance with published guidelines, with emphasis on titration of proven neurohormonal therapies for HF. Serial measurement of NT-proBNP testing was discouraged in the usual care group. MAIN OUTCOMES AND MEASURES: The primary end point was the composite of time-to-first HF hospitalization or cardiovascular mortality. Prespecified secondary end points included all-cause mortality, total hospitalizations for HF, days alive and not hospitalized for cardiovascular reasons, the individual components on the primary end point, and adverse events. RESULTS: The data and safety monitoring board recommended stopping the study for futility when 894 (median age, 63 years; 286 32% women) of the planned 1100 patients had been enrolled with follow-up for a median of 15 months. The primary end point occurred in 164 patients (37%) in the biomarker-guided group and 164 patients (37%) in the usual care group (adjusted hazard ratio HR, 0.98; 95% CI, 0.79-1.22; P = .88). Cardiovascular mortality was 12% (n = 53) in the biomarker-guided group and 13% (n = 57) in the usual care group (HR, 0.94; 95% CI; 0.65-1.37; P = .75). None of the secondary end points nor the decreases in the NT-proBNP levels achieved differed significantly between groups. CONCLUSIONS AND RELEVANCE: In high-risk patients with HFrEF, a strategy of NT-proBNP–guided therapy was not more effective than a usual care strategy in improving outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01685840
Background:
Acute hematogenous periprosthetic joint infection (PJI) is defined in the literature as infection diagnosed and treated within 2 to 4 weeks from the onset of symptoms. In total hip and ...knee arthroplasty, irrigation and debridement (I&D) and polyethylene exchange with component retention has been studied extensively. However, there is minimal literature evaluating this treatment method for PJI in total ankle arthroplasty (TAA). The purpose of this study was to evaluate both the clinical and patient-reported outcomes and survivorship of TAA acute hematogenous PJIs treated with I&D and polyethylene exchange.
Methods:
A single-center, retrospective chart review of prospectively collected data in patients with TAA PJI who subsequently underwent I&D and polyethylene exchange with retention of metal components was conducted. The primary outcome was failure rate of I&D and polyethylene exchange, where failure was defined as subsequent removal of all components and 2-stage revision or arthrodesis. Patient-reported outcomes collected before primary arthroplasty, after primary arthroplasty, and after polyethylene exchange were also analyzed.
Results:
We identified 14 patients with acute hematogenous PJI who underwent I&D and polyethylene exchange with retention of metal components. The mean time from primary TAA to symptoms was 43 months (range 1-147 months). The average time from onset of symptoms to I&D and polyethylene exchange was 11.4 ± 5.6 days. The mean follow-up after this surgery was 2.8 ± 1.5 years. The long-term failure rate was 54%. The most common bacteria isolated in patients who failed was methicillin-resistant Staphylococcus aureus (MRSA). The most common bacteria isolated in patients who retained their implants was methicillin-sensitive Staphylococcus aureus (MSSA). Visual analog scale (VAS), Short Musculoskeletal Function Assessment (SMFA), Short Form-36 (SF-36), and American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot scale showed significant improvement when compared to preoperative scores in patients who retained their implants both after primary and after I&D and polyethylene exchange.
Conclusions:
I&D and polyethylene exchange with retention of metal components has a long-term survivorship comparable to those reported in the total knee and total hip arthroplasty literature. Patient-reported outcomes after I&D and polyethylene exchange were comparable to those collected after primary arthroplasty in those patients who ultimately retained their implants. Two variables in this cohort that were associated with I&D and polyethylene exchange failure include time the patient was symptomatic prior to I&D as well as organism isolated on culture. With a failure rate of 54%, the authors recommend thorough evaluation on a case-by-case basis prior to indicating a patient for single-stage I&D with polyethylene exchange.
Levels of Evidence:
Level IV, case series.
Imaging biomarker roadmap for cancer studies O'Connor, James P B; Aboagye, Eric O; Adams, Judith E ...
Nature reviews. Clinical oncology,
03/2017, Volume:
14, Issue:
3
Journal Article
Peer reviewed
Open access
Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection ...fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.
Supporting Spartina Bortolus, Alejandro; Adam, Paul; Adams, Janine B. ...
Ecology (Durham),
November 2019, Volume:
100, Issue:
11
Journal Article
Peer reviewed
Open access
In 2014, a DNA-based phylogenetic study confirming the paraphyly of the grass subtribe Sporobolinae proposed the creation of a large monophyletic genus Sporobolus, including (among others) species ...previously included in the genera Spartina, Calamovilfa, and Sporobolus. Spartina species have contributed substantially (and continue contributing) to our knowledge in multiple disciplines, including ecology, evolutionary biology, molecular biology, biogeography, experimental ecology, biological invasions, environmental management, restoration ecology, history, economics, and sociology. There is no rationale so compelling to subsume the name Spartina as a subgenus that could rival the striking, global iconic history and use of the name Spartina for over 200 yr. We do not agree with the subjective arguments underlying the proposal to change Spartina to Sporobolus. We understand the importance of both the objective phylogenetic insights and of the subjective formalized nomenclature and hope that by opening this debate we will encourage positive feedback that will strengthen taxonomic decisions with an interdisciplinary perspective. We consider that the strongly distinct, monophyletic clade Spartina should simply and efficiently be treated as the genus Spartina.
In countries with the best cancer outcomes, approximately 60% of patients receive radiotherapy as part of their treatment, which is one of the most cost-effective cancer treatments. Notably, around ...40% of cancer cures include the use of radiotherapy, either as a single modality or combined with other treatments. Radiotherapy can provide enormous benefit to patients with cancer. In the past decade, significant technical advances, such as image-guided radiotherapy, intensity-modulated radiotherapy, stereotactic radiotherapy, and proton therapy enable higher doses of radiotherapy to be delivered to the tumour with significantly lower doses to normal surrounding tissues. However, apart from the combination of traditional cytotoxic chemotherapy with radiotherapy, little progress has been made in identifying and defining optimal targeted therapy and radiotherapy combinations to improve the efficacy of cancer treatment. The National Cancer Research Institute Clinical and Translational Radiotherapy Research Working Group (CTRad) formed a Joint Working Group with representatives from academia, industry, patient groups and regulatory bodies to address this lack of progress and to publish recommendations for future clinical research. Herein, we highlight the Working Group's consensus recommendations to increase the number of novel drugs being successfully registered in combination with radiotherapy to improve clinical outcomes for patients with cancer.
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