The Spinal Fusion Indications and Outcomes Randomised Trial (SPINOUT)
Research type
Research Study
Full title
The Spinal Fusion Indications and Outcomes Randomised Trial – a Feasibility study
IRAS ID
246379
Contact name
Dominique Rothenfluh
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN15462386
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
As people age, there is increasing wear on the bones in their spine. The spine responds to this by producing extra bone and changing its shape, sometimes with one vertebra slipping on another. These changes can narrow the normal spaces where nerves pass through the spinal cord, creating an unstable spine. When the nerves get pressed, back and leg pain occurs with substantial interference on daily life and on mental and physical well-being. When severe, surgery may be necessary to relieve that pressure. This is now the most common spinal disorder requiring surgery. 18,000 procedures are performed each year in the NHS.
Surgical treatment can involve decompression surgery - removing the bone that presses on the nerves. It could also involve the insertion of screws and rods (called an instrumented fusion) to support the spine. There is no evidence and no agreement between surgeons as to which is better. The decompression surgery might need a revision sooner, but instrumented fusion might be too invasive for a first line surgical treatment.
Ultimately a research study called a randomised trial is needed to inform this decision but such a trial will not be easy to conduct. Before we do a large study like this we need to consider how a study like this would work in practice. We need to know if patients and surgeons would be willing to take part, how they feel about the two different operations and how we should measure “success” after the operation. This is called a feasibility study and will tell us if a larger study is possible and how it should be run to give us an answer to this clinical question.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0068
Date of REC Opinion
4 Apr 2019
REC opinion
Further Information Favourable Opinion