The spinal fusion indications and outcomes randomised trial – a feasibility study

niversity of Oxford0 sites6 target enrollmentMay 15, 2019

Overview

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37549931/ (added 10/06/2024)

Registry

who.int

Start Date

May 15, 2019

End Date

September 30, 2020

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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 \<70mm2 in the MRI on 1 or 2 levels corresponding to L3/4, L4/5 or L5/S1
•5\. Confirmed diagnosis of either or both:
•5\.1\. Loss of lumbar curvature (spino\-pelvic malalignment) measured as pelvic incidence\-lumbarlordosis mismatch 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

•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