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

IntroductionPelvic 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. Min...

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Published inBMJ open Vol. 9; no. 7; p. e032111
Main Authors van Berkel, Dawn, Ong, Terence, Drummond, Avril, Hendrick, Paul, Leighton, Paul, Jones, Matthew, Salem, Khalid, Quraishi, Nasir, Brookes, Cassandra, Suazo Di Paola, Ana, Edwards, Sarah, Sahota, Opinder
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Abstract IntroductionPelvic 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 analysisASSERT (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 disseminationEthical 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 numberISRCTN16719542; Pre-results.
AbstractList 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.
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.INTRODUCTIONPelvic 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.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.METHODS AND ANALYSISASSERT (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.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.ETHICS AND DISSEMINATIONEthical 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.ISRCTN16719542; Pre-results.TRIAL REGISTRATION NUMBERISRCTN16719542; Pre-results.
IntroductionPelvic 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 analysisASSERT (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 disseminationEthical 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 numberISRCTN16719542; Pre-results.
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. 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. 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. ISRCTN16719542; Pre-results.
Author Drummond, Avril
Suazo Di Paola, Ana
Sahota, Opinder
Ong, Terence
Jones, Matthew
Brookes, Cassandra
Edwards, Sarah
van Berkel, Dawn
Quraishi, Nasir
Salem, Khalid
Hendrick, Paul
Leighton, Paul
AuthorAffiliation 3 Division of Physiotherapy and Rehabilitation Sciences, School of Health Sciences , University of Nottingham , Nottingham , UK
4 Division of Primary Care, School of Medicine , University of Nottingham , Nottingham , UK
6 Leicester Clinical Trials Unit , University of Leicester , Leicester , UK
2 School of Health Sciences , University of Nottingham , Nottingham , UK
5 Centre for Spinal Studies and Surgery , Nottingham University Hospitals NHS Trust , Nottingham , UK
1 Health Care of the Older People Division , Nottingham University Hospitals NHS Trust , Nottingham , UK
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/31296516$$D View this record in MEDLINE/PubMed
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Issue 7
Keywords spine
qualitative research
geriatric medicine
adult orthopaedics
health economics
Language English
License This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Snippet IntroductionPelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to...
Pelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to the...
Introduction Pelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related...
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StartPage e032111
SubjectTerms Aged
Aged, 80 and over
Bones
Cognitive ability
Comorbidity
Cost-Benefit Analysis
Evidence-based medicine
Feasibility Studies
Female
Fractures
Geriatric Medicine
Hip Fractures - surgery
Hospitals
Humans
Hypothesis testing
Male
Minimally Invasive Surgical Procedures - economics
Minimally Invasive Surgical Procedures - methods
Mortality
Narcotics
Older people
Pain management
Pain Management - methods
Patients
Qualitative research
Quality of Life
Research Design
Sacrum - injuries
Spine - surgery
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Title ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol
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Volume 9
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