Study Background and Design

As people age, there is increasing wear on the bones (vertebrae) in the spine. The spine responds by producing extra bone in some areas, changing its shape in others and sometimes with one vertebra slipping on another. All these changes can narrow the normal spaces where the nerves pass from the spinal cord. 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 operations are performed each year in the NHS. Surgery can involve removing the bone that presses on the nerves (called decompression). Or it could involve, in addition, the insertion of screws and rods (called an instrumented fusion) to make the spine straighter and stronger to achieve long term benefit. There is no agreement between surgeons as to which is better. The instrumented fusion operations are more complex and take into consideration the varying affect on individual patient spines. Unfortunately, there is very limited evidence for patients and surgeons to make an informed choice.

Ultimately a research study called a randomised trial is needed to inform this decision, but this will not be easy to conduct. Therefore the aim of the SPINOUT-F study is to evaluate whether such a trial is feasibile. We will be looking at particularly whether patiens and surgeons and willing to take part in a study and how we should measure success after the operation.

To investigate this, the SPINOUT-F study will randomise 60 patients in a small number of NHS hospitals to receive either decompression surgery only or decompression surgery with instrumented fusion. We will also be holding focus groups to hear the opinions of patients.