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| Funder | National Institute for Health and Care Research |
|---|---|
| Recipient Organization | Nottingham University Hospitals Nhs Trust |
| Country | United Kingdom |
| Start Date | Apr 06, 2021 |
| End Date | Oct 06, 2022 |
| Duration | 548 days |
| Number of Grantees | 2 |
| Roles | Principal Investigator; Award Holder |
| Data Source | NIHR Open Data-Funded Portfolio |
| Grant ID | NIHR201937 |
Research question Is a spinal medial branch nerve root block 'as clinically effective' and 'cost-effective' as routine spinal key-hole surgery, for the treatment of painful vertebral fragility fractures in older, hospitalised patients? Background Vertebral Fragility Fractures (VFF) are the most common osteoporosis related fracture.
These are painful, may require admission to hospital and may require surgical intervention. Hospitalised patients are elderly, have multiple co-morbidities and thus surgery is more challenging.
Routine surgery involves minimally invasive key-hole augmentation whereby bone cement is injected into the fractured vertebra-vertebroplasty (VP).
Although NICE has approved the use of both VP and balloon kyphoplasty (BKP), BKP is more commonly reserved for younger patients with traumatic fractures, in the UK. VP is effective in reducing pain and relatively safe, but requires a general anaesthetic (GA).
It may cause complications and is expensive (£4,500 per case). 81 patients underwent VP in Nottingham last year, with some patients requiring multiple level treatment, at an estimated overall cost of £650,000.
More recently, the use of a spinal medial branch nerve root block (MBNB) has been shown to be equally 'as effective' in reducing pain, does not require a GA and is one tenth the cost of VP. However whether the analgesic effects and the potential cost saving are sustained, requires further evaluation.
Aim Undertake a preliminary study to help design a future trial to evaluate the clinical and cost effectiveness of MBNB compared to routine VP spinal surgery.
Objectives -Estimate the number of patients who meet eligibility criteria; adhere to randomisation and complete follow-up; -Pilot the procedures involved in the trial; -Examine completeness and variability of outcome measures and health resources.
Methods Design: 18 month, randomised controlled, feasibility study Setting: Secondary care, with week 1 (face to face) and week 4 and 8 (telephone) follow up Target population: Hospitalised older patients (aged 70 yrs and over) awaiting spinal VP surgery Inclusion: ambulatory before the injury;
Nottingham University Hospitals Nhs Trust
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