The Nottingham spinal health study

Not Applicable

Completed

• Conditions: Vertebral fractures, including those in patients with osteoporosis; Musculoskeletal Diseases; 1. Osteoporosis 2. Vertebral fractures

• Registration Number: ISRCTN14436287
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-20
• Study Completion: 2018-03-15
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Mood is measured using the Geriatric Depression Scale at baseline (on admission to hospital) and at 6 months<br> 3. Cognition is measured using the Montreal Cognitive Assessment at baseline (on admission to hospital) and at 6 months<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Hospital inpatient mortality and overall mortality are measured by analysing healthcare records at 6 months<br> 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)<br> 3. Quality of life post-hospitalisation for vertebral fractures is measured using the EQ-5D measured at 6 months<br> 4. Healthcare resource utilisation after hospital discharge is measured through self or proxy reporting at 6 months<br>