Abstract:
BACKGROUND:An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to investigate if this individualized treatment algorithm gives a better functional outcome than treating all patients either operatively or non-operatively per default. METHODS/DESIGN:This study is conducted as a multicenter, three-armed randomized controlled trial. Participants are included from four hospitals in Denmark and randomized 1:1:1 to one of three parallel groups: 1) Intervention group-participants are treated according to an individualized treatment algorithm; 2) Control group A-participants are treated non-operatively; 3) Control group B-participants are treated operatively. The individualized treatment algorithm for the intervention group is based on an ultrasonographic examination; tendon overlap and elongation below 7% is to be treated non-operatively, while no tendon overlap and/or elongation above 7% will be treated operatively. Over a period of 3 years, 300 participants will be included. The primary outcome is the heel-rise work test at 12 months post-injury. Secondary outcomes are tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures, and other complications. The primary analysis will be conducted as an intention-to-treat analysis. DISCUSSION:This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatments instead of offering all the same treatment. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03525964. Registered 16 May 2018.
journal_name
Trialsjournal_title
Trialsauthors
Hansen MS,Vestermark MT,Hölmich P,Kristensen MT,Barfod KWdoi
10.1186/s13063-020-04332-zsubject
Has Abstractpub_date
2020-05-12 00:00:00pages
399issue
1issn
1745-6215pii
10.1186/s13063-020-04332-zjournal_volume
21pub_type
杂志文章,多中心研究,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare. MAIN BODY:Prot...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-018-2510-1
更新日期:2018-02-17 00:00:00
abstract:BACKGROUND:Burns and the associated wound care procedures can be extremely painful and anxiety-provoking for children. Burn injured children and adolescents are therefore at greater risk of experiencing a range of psychological reactions, in particular posttraumatic stress disorder, which can persist for months to year...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1346-9
更新日期:2016-04-29 00:00:00
abstract:BACKGROUND:Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting of human placental extract, has been reported as effective for treating chronic musculoskeletal diso...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04442-8
更新日期:2020-06-15 00:00:00
abstract:BACKGROUND:Osteoarthritis often results in prolonged periods of reduced physical activity and is associated with adverse health outcomes, including increased risk of cardiovascular and metabolic diseases. Exercise interventions for patients on the waiting list for arthroplasty can reduce the risk of long-term adverse o...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2808-z
更新日期:2018-08-07 00:00:00
abstract:BACKGROUND:Young men in South Africa face concurrent epidemics of HIV, drug and alcohol abuse, and unemployment. Standard HIV prevention programs, located in healthcare settings and/or using counseling models, fail to engage men. Soccer and vocational training are examined as contexts to deliver male-specific, HIV prev...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2804-3
更新日期:2018-08-03 00:00:00
abstract::Periconceptional supplementation could extend the period over which maternal and fetal nutrition is improved, but there are many challenges facing early-life intervention studies. Periconceptional trials differ from pregnancy supplementation trials, not only because of the very early or pre-gestational timing of nutri...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-015-1124-0
更新日期:2016-01-30 00:00:00
abstract:BACKGROUND:Staphylococcus aureus bacteremia (SAB) is frequently encountered in the hospital setting, and current guidelines recommend at least 14 days of antibiotic treatment for SAB in order to minimize risks of secondary deep infections and relapse. However, evidence to support these treatment recommendations remains...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3357-9
更新日期:2019-05-02 00:00:00
abstract:BACKGROUND:Gastroesophageal reflux disease lowers the quality of life and increases medical costs. Electroacupuncture has been used to ease symptoms and improve gastrointestinal motility in patients with gastroesophageal reflux disease. The main purposes of this study are to evaluate the efficacy and safety of this pro...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1371-8
更新日期:2016-05-17 00:00:00
abstract:BACKGROUND:The per-protocol effect is the effect that would have been observed in a randomized trial had everybody followed the protocol. Though obtaining a valid point estimate for the per-protocol effect requires assumptions that are unverifiable and often implausible, lower and upper bounds for the per-protocol effe...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-1056-8
更新日期:2015-11-30 00:00:00
abstract:OBJECTIVES:Entertainment-education (E-E) media can improve behavioral intent toward health-related practices. In the era of COVID-19, millions of people can be reached by E-E media without requiring any physical contact. We have designed a short, wordless, animated video about COVID-19 hygiene practices-such as social ...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-020-04449-1
更新日期:2020-06-03 00:00:00
abstract:BACKGROUND:Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1520-0
更新日期:2016-08-03 00:00:00
abstract:BACKGROUND:The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. METHO...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2534-6
更新日期:2018-03-15 00:00:00
abstract:BACKGROUND:Co-infection with malaria parasite and HIV is an emerging public health problem in tropical areas, particularly in pregnant women, and management of the concurrent effects of these two infections is challenging. Co-trimoxazole is a sulfamide preparation used to prevent opportunistic infections in HIV-infecte...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-255
更新日期:2013-08-14 00:00:00
abstract:BACKGROUND:Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medica...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-1055-9
更新日期:2015-12-12 00:00:00
abstract:BACKGROUND:Juvenile dermatomyositis (JDM) is a rare autoimmune inflammatory disorder associated with significant morbidity and mortality. International collaboration is necessary to better understand the pathogenesis of the disease, response to treatment and long-term outcome. To aid international collaboration, it is ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-015-0784-0
更新日期:2015-06-12 00:00:00
abstract:BACKGROUND:Cigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Despite the risks, the most effective antenatal model of care for smokers is still unclear, and specific recommendations for screening for fetal growth...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3653-4
更新日期:2019-09-03 00:00:00
abstract:BACKGROUND:People with serious mental illness (SMI) (psychosis, bipolar disorder and major depressive disorder) experience a considerable risk of premature mortality because of cardiovascular disease. Recent research has demonstrated that this population spends almost 13 h per day being sedentary. Sedentary behaviour i...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1660-2
更新日期:2016-12-12 00:00:00
abstract:BACKGROUND:Biomass fuel smoke is a leading risk factor for the burden of disease worldwide. International campaigns are promoting the widespread adoption of liquefied petroleum gas (LPG) in resource-limited settings. However, it is unclear if the introduction and use of LPG stoves, in settings where biomass fuels are u...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2179-x
更新日期:2017-11-03 00:00:00
abstract:BACKGROUND:Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04986-9
更新日期:2021-01-11 00:00:00
abstract:BACKGROUND:Extended brief interventions (EBIs) are effective in targeting alcohol misuse in the general population. However, little is known of the effects of EBI in adults with intellectual (also known as learning) disabilities. In this feasibility trial we compared EBI with usual care for alcohol misuse in adults wit...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-017-1953-0
更新日期:2017-05-12 00:00:00
abstract:BACKGROUND:Depression is a debilitating and costly disease for our society, especially in the case of treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy in treatment-resistant unipolar and non-psychotic depression. It can be applied according to tw...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04255-9
更新日期:2020-04-05 00:00:00
abstract:BACKGROUND:Sleep disturbance in older people is an important health issue that is associated with many other health problems. Effective interventions are required to address sleep problems in this group. Acupressure has been suggested as a potential therapeutic technique to improve sleep. The aim of this study is to ev...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04286-2
更新日期:2020-04-25 00:00:00
abstract:BACKGROUND:Exercise-based cardiac rehabilitation is a beneficial therapy for patients with chronic heart failure. The delivery of exercise-based cardiac rehabilitation should adopt an evidence-based approach, as well as be culturally appropriate and sensitive to individual needs and preferences. The Baduanjin Eight-Sil...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2531-9
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:Acupuncture has been widely applied in the clinic to treat irritable bowel syndrome (IBS), but the underlying mechanism remains unknown. Diffuse noxious inhibitory control (DNIC) is deficient in patients with IBS, which attenuates the systemic analgesic effect elicited by noxious stimulation that is remote f...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2948-1
更新日期:2018-10-16 00:00:00
abstract:BACKGROUND:Less invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04390-3
更新日期:2020-06-11 00:00:00
abstract:BACKGROUND:Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its occurrence in primary school. This study was conducted in 2017, in 10 primary schools in the Western...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-018-3043-3
更新日期:2018-11-29 00:00:00
abstract:BACKGROUND:South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motiv...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3551-9
更新日期:2019-07-26 00:00:00
abstract:BACKGROUND:The practice of traditional Chinese medicine (TCM) has a profound history in many Asian countries. TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients. Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-84
更新日期:2014-03-19 00:00:00
abstract::After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2]. ...
journal_title:Trials
pub_type: 杂志文章,已发布勘误
doi:10.1186/s13063-018-3089-2
更新日期:2018-12-24 00:00:00
abstract:BACKGROUND:Resistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health problem. At present clinical trial data on management of resistant hypertension is limited. Managemen...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1863-1
更新日期:2017-03-14 00:00:00