The Nottingham spinal health study
| ISRCTN | ISRCTN14436287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14436287 |
| Secondary identifying numbers | 16HC004 |
- Submission date
- 29/11/2016
- Registration date
- 20/12/2016
- Last edited
- 13/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Fragility fractures are a type of fracture which occurs as a result of normal activity, such as a fall from standing height or less. Low-trauma vertebral fractures are fragility fractures affecting the small bones that make up the spine (vertebra). It is most commonly caused by osteoporosis, a long-term condition where bones become brittle and break easily. Vertebral fragility fractures can lead to pain, limitation in daily activities, and is associated with further fragility fractures and worse healthcare outcomes. The majority of vertebral fragility fractures are treated in the community, and so those that do need admission to hospital are more likely to have sustained a serious fracture and be in significant pain and disability. This specific group of patients has not been robustly studied and this study aims to describe the characteristics of patients admitted to hospital with a vertebral fragility fracture, their care in hospital and health outcomes associated with it at six months.
Who can participate?
Adults aged 50 years and over who have been admitted to hospital because of a vertebral fragility fracture or suspected vertebral fragility fracture.
What does the study involve?
Participants who have been admitted to hospital because of a vertebral fragility fracture or suspected vertebral fragility fracture are approached by the study team to complete a number of questionnaires. In addition, their medical records are reviewed for background information about their health. Six months later, participants are contacted and repeat the initial questionnaires to look at the long-term outcomes of their fracture.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to those taking part.
Where is the study run from?
Queens Medical Centre, Nottingham (UK)
When is the study starting and how long is it expected to run for?
August 2016 to March 2018
Who is funding the study?
Dunhill Medical Trust (UK)
Who is the main contact?
Dr Terence Ong
terenceong@doctors.org.uk
Contact information
Scientific
Department for Healthcare of Older People
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0001-7473-446X |
|---|---|
| Phone | +44 1159 249924 ext 62793/62511 |
| terenceong@doctors.org.uk |
Study information
| Study design | Single centre prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | ISRCTN14436287_PIS_22Sep16_V3.docx |
| Scientific title | Nottingham Spinal Health (NoSH) Study: A cohort study of vertebral fragility fractures admitted to hospital |
| Study acronym | NoSH |
| Study objectives | The aim of this study is to describe characteristics of adult patients admitted to hospital with vertebral fragility fractures and their associated outcomes. Findings from this study will inform the potential development of a specialist service for vertebral fracture management in hospital. |
| Ethics approval(s) | Ethics approval provided by the East of England - Cambridge Central Research Ethics Committee, 22/07/2016, ref: 16/EE/0249 |
| Health condition(s) or problem(s) studied | Vertebral fractures, including those in patients with osteoporosis |
| Intervention | Patients with a diagnosed or suspected diagnosis of an acute vertebral fragility fracture will be invited to participate in the study. Data collection will be conducted on admission, at discharge from hospital and at 6 months follow up post-discharge. Range of data collected are detailed in the accompanying section of this application. Data will be gathered from patient questionnaire and their medical case notes. This observational study will not interfere with the care delivered as part of their hospital admission. |
| Intervention type | Other |
| Primary outcome measure | 1. Pain is measured using an 11 point numeric rating scale at baseline (on admission to hospital), on discharge from hospital and at 6 months 2. Mood is measured using the Geriatric Depression Scale at baseline (on admission to hospital) and at 6 months 3. Cognition is measured using the Montreal Cognitive Assessment at baseline (on admission to hospital) and at 6 months 4. Disability is measured using the Elderly Mobility Scale, Barthel Index, Nottingham Extended Activities of Daily Living and Roland Morris Disability Questionnaire at baseline (on admission to hospital) and at 6 months |
| Secondary outcome measures | 1. Hospital inpatient mortality and overall mortality are measured by analysing healthcare records at 6 months 2. Hospital related outcomes measured by analysing hospital paper and electronic healthcare records on patients discharge - length of stay, discharge destination/changes in residency, hospital related complication (hospital acquired infection, pressure sore, venous thromboembolic event, delirium and neurological impairment) 3. Quality of life post-hospitalisation for vertebral fractures is measured using the EQ-5D measured at 6 months 4. Healthcare resource utilisation after hospital discharge is measured through self or proxy reporting at 6 months |
| Overall study start date | 10/08/2016 |
| Completion date | 15/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Adults aged 50 years and over 2. Admitted to hospital with either a low trauma or atraumatic vertebral fragility fracture or suspected vertebral fragility fracture pending radiology investigation. A low trauma fracture is a fracture sustained after a fall from a standing height or less. A diagnosis of vertebral fracture is made radiologically (i.e. x-ray imaging, computerised tomography (CT), magnetic resonance imaging (MRI) of the spine) or bone (scintigraphy) scan. 3. While in hospital was diagnosed with a vertebral fragility fracture unrelated to their index admission |
| Key exclusion criteria | 1. Patients without a vertebral fracture 2. Patients admitted electively to hospital for management of their vertebral fracture 3. Patients transferred from another hospital 4. Vertebral fracture sustained as a result of a high impact injury, e.g. road traffic accident, fall down a flight of stairs, etc. 5. Patients presenting with a concomitant fracture elsewhere 6. Patients admitted to hospital under a major trauma pathway 7. Patients with known or suspected malignancy 8. Patients with known primary bone disorder (e.g Paget’s disease) other than osteoporosis 9. Patients terminally ill or moribund |
| Date of first enrolment | 28/09/2016 |
| Date of final enrolment | 18/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Phone | +44 1159 249924 ext 70659 |
|---|---|
| researchsponsor@nuh.nhs.uk | |
| Website | http://nuhrise.org/ |
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Dunhill Medical Trust, DMT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 16/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned dissemination of findings through participation at relevant conferences, publication in peer-reviewed journals, clinical and research networks, and engagement with our patient and public involvement group. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from terenceong@doctors.org.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3 | 22/09/2016 | 12/01/2017 | No | Yes |
| Basic results | 14/03/2019 | 26/03/2019 | No | No | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN14436287_PIS_22Sep16_V3.docx
- Uploaded 12/01/2017
- ISRCTN14436287_BasicResults_14Mar19.pdf
- Uploaded 26/03/2019
Editorial Notes
13/03/2020: Internal review.
06/11/2019: Internal review.
26/03/2019: The basic results of this trial have been uploaded as an additional file.
12/01/2017: Uploaded participant information sheet.
