Spinal fusion Surgery
Conditions
Interventions
SPINOUT-F is a feasibility study, consisting of a randomised pilot trial and patient focus groups.
Randomised pilot
Patients will be recruited via outpatient clinics. They will have the opportunity a
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 40 years of age 2. Radicular leg pain or claudication symptoms greater than or equal to back pain for whom surgery is considered an option 3. Failed conservative treatment (eg physiotherapy, injections, pain medication) 4. Either: 4.1. Confirmed nerve compression in the lateral recess or exit foramen or 4.2. Central spinal stenosis with cross-sectional area of the dural sac of 10° measures on lateral radiograph with inclusion of femoral heads and/or 5.2. Degenerative spondylolisthesis with an increase of the slip on the standing radiograph compared to the supine MRI to more than >25% or >5mm translation on a standing lateral radiograph indicating a higher degree slip
Exclusion criteria
Exclusion criteria: 1. Isthmic spondylolisthesis 2. Previous spinal surgery in the thoraco-lumbar spine 3. Degenerative scoliosis of the lumbar spine of > 10° 4. Smoking 5. Body mass index > = 35 kg/m2 6. Clinical history of osteoporotic fracture or chronic oral steroid use 7. Evidence of neurological disorders (eg multiple sclerosis, Parkinson’s) or systemic illnesses (eg inflammatory arthritis) that effect physical function 8. Unable to give informed consent 9. Patients who are involved in any other ongoing research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The practicability of a multicentre RCT of instrumented spinal fusion in addition to decompression surgery compared to decompression surgery alone. This will be measured by the completion of both recruitment and follow up in a randomised pilot study at the end of the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The availability of sufficient eligible patients and ability to recruit across sites at an adequate rate. This will be measured by the identification of eligible patients recorded on screening forms at the end of the study period 2. Adherence to allocated surgery and intended surgical approach. This will be measured by the completion of allocated surgical procedure at the end of the study period 3. Whether the surgical approaches can be standardised and delivered appropriately across multiple sites/surgeons. This will be measured by the compliance with protocol requirements at the end of the study period 4. Ability to collect key follow-up data. This will be measured by the completion of follow-up at 3 months post randomisation. 5. Quality of life after surgery. This will be measured by the Visual Analogue Scale, Oswestry Disability Index, Measure Yourself Medical Outcome Profile and EQ-5D-5L at 3 months post randomisation 6. Post-operative spinal curvature. This will be measured by post-operative X-rays at 3 months post randomisation 7. The feasibility of an definitive economic evaluation of instrumented fusion and decompression. This will be measured by health resource use and EQ-5D-5L at 3 months post randomisation 8. The outcomes that are relevant and important to patients to inform the main trial. This will be measured by the themes identified in patient focus groups at the end of the study period | — |
Countries
England, United Kingdom
Outcome results
None listed