Dataset Information

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol.

ABSTRACT:

Introduction

Pelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to the challenges of appropriate pain control and early mobilisation. The current standard for treatment of PFF is non-surgical management. Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe. Randomised controlled trials are required before recommendations can be made for surgical management of PFF to become the new standard of care. This feasibility study will explore several uncertainties around conducting such a trial.

Methods and analysis

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) is a single-site randomised controlled, parallel-arm, feasibility trial of surgical stabilisation versus non-surgical management of acute sacral fragility fractures in people aged 70 years and over. Patients will be randomised to either surgical or non-surgical group on a 1:1 ratio. Follow-up of participants will occur at 2, 4 and 12 weeks with safety data collected at 52 weeks. Primary objectives are to determine feasibility and design of a future trial, including outcomes on recruitment, adherence to randomisation and safety. This will be supplemented with a qualitative interview study of participants and clinicians. Secondary objectives will inform study design procedures to determine clinical and economic outcomes between groups, including scored questionnaires, analgesia requirements, resource use and quality of life data. Data analysis will be largely descriptive to inform outcomes and future sample size.

Ethics and dissemination

Ethical approval was granted by the North East Newcastle and North Tyneside 2 Research Ethics Committee (reference 18/NE/0212). ASSERT was approved and sponsored by Nottingham University Hospitals NHS Trust (reference 18HC001) and the Health Research Authority (reference IRAS 232791). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals on study completion.

Trial registration number

ISRCTN16719542; Pre-results.

SUBMITTER: van Berkel D

PROVIDER: S-EPMC6624053 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol.

van Berkel Dawn D Ong Terence T Drummond Avril A Hendrick Paul P Leighton Paul P Jones Matthew M Salem Khalid K Quraishi Nasir N Brookes Cassandra C Suazo Di Paola Ana A Edwards Sarah S Sahota Opinder O

BMJ open 20190710 7

<h4>Introduction</h4>Pelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to the challenges of appropriate pain control and early mobilisation. The current standard for treatment of PFF is non-surgical management. Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe. Randomised controlled trial ...[more]

PMID: 31296516

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Project description:ObjectiveTo determine the feasibility of designing and conducting a definitive trial to evaluate the effectiveness of sacral fracture fixation compared with non-surgical management among older people admitted with a lateral compression pelvic fragility fracture (PFF).DesignSingle-site, parallel, two-arm randomised controlled feasibility trial.SettingA UK tertiary centre hospital.ParticipantsPatients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF.InterventionsThe intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team.Primary and secondary outcome measuresThe feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events.Results241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial.ConclusionsThere were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial.Trial registration numberISRCTN16719542.

Project description:IntroductionGuidelines for hip fracture care state that patients with hip fracture should be mobilised on the day after surgery and at least once a day thereafter. However, compliance with these guidelines is poor. One approach that would assist physiotherapists to meet mobility guidelines after hip fracture is to delegate the provision of daily mobilisation to allied health assistants under their supervision. Therefore, we plan to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient rehabilitation to patients with hip fracture.Methods and analysisUsing a parallel group randomised controlled design with one-to-one allocation, participants will be randomly allocated to an experimental group (allied health assistant management) or a comparison group (physiotherapist management). Inclusion criteria are: adult with diagnosis of hip fracture; inpatient in acute hospital; walked independently pre-hip fracture and able to communicate in conversational English. The experimental group will receive routine physiotherapy rehabilitation, including daily mobilisation, from an allied health assistant following initial physiotherapist assessment. The comparison group will receive routine rehabilitation from a physiotherapist. The primary outcome will be the feasibility of allied health assistant management of patients with hip fracture. Feasibility will be determined using the following areas of focus in Bowen's feasibility framework: acceptability (patient satisfaction), demand (proportion of patients who participate), implementation (time allied health assistant/physiotherapist spends with participant, occasions of service) and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant care will be interviewed to explore their perspectives on feasibility. Secondary outcomes include compliance with daily mobilisation guidelines, discharge destination, hospital readmission, falls, functional activity and length of stay. We aim to recruit 50 participants. Descriptive statistics will be used to describe feasibility and mobilisation rates will be calculated using Cox proportional hazards regression to compare compliance with mobilisation guidelines.Ethics and disseminationEthics approval was obtained from the Peninsula Health human research ethics committee (HREC/63 005/PH-2020). The findings will be disseminated in peer-reviewed journals and conference presentations.Trail registration numberAustralian and New Zealand Clinical Trial Registry; ACTRN12620000877987; Pre-results.

Project description:BackgroundThe number and proportion of older people globally is growing faster than that of any other age group. At the same time the number of people retaining some of their own teeth is rising. There significant differences between those living in care and their community dwelling peers, with evidence showing those in care having fewer teeth and significantly higher levels of dental decay. There are numerous Cochrane reviews linking the use of fluoride to a reduction in dental decay, however, the majority of research on effectiveness has been conducted on children and consequently, children and adolescents tend to be the main recipients of fluoride interventions. There are to date no studies comparing the effectiveness of fluoride interventions in older people in care homes in the UK. However, prior to developing an appropriate protocol for full-scale trial comparing clinical effectiveness of fluoride interventions, there are a number of trial feasibility and statistical parameters that need to be clarified.MethodsThis trial is a single centre, multi-site randomised controlled assessor blind parallel group (three groups) trial, with the primary objective of establishing the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. Secondary and tertiary objectives will aim to explore the acceptability of the interventions from resident, care home and dental services perspectives, and estimate the efficacy of the three different fluoride treatments.DiscussionThis feasibility trial will produce new knowledge and add value to a landscape that is under researched. Although the efficacy of fluoride interventions is proven, the feasibility of dental research and prevention in this vulnerable group and in the complex care home setting is novel. This work will not only add to our understanding of the interface of dental care and social care but will also contribute to our broader understanding on undertaking research in care home settings. Dental care for older people has been a longstanding issue, and the events of this past year has shone a light on the vulnerabilities of those residing in care homes and so this research is landing at a pivotal time. Trial registration EudraCT Registration 2017-002248-34. Registered 20th February 2018 https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002248-34 .

Project description:INTRODUCTION:Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker. METHODS AND ANALYSIS:The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12?months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial. ETHICS AND DISSEMINATION:Ethical approval for the study was given by the South West-Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences. TRIAL REGISTRATION NUMBER:ISRCTN10649958.

Project description:IntroductionDeficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices.Methods and analysisThis randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1 and 2 years after the end of the treatment. Only subjects hospitalised 4 weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30 min sessions of traditional therapy and 20 min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50 min. The primary outcomes are risk of falling, gait performance and fear of falling.Ethics and disseminationThe study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19 014. Trial results will be submitted for publication in journals and conferences.Trial registration numberNCT04095338.

Project description:IntroductionVertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients.MethodA parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data.Ethics and disseminationEthical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion.Trial registration numberISRCTN18334053.

Dataset Information

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol.

Similar Datasets

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