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

niversity of Oxford0 个研究点目标入组 6 人开始时间: 2019年5月15日最近更新: 2024年6月24日

适应症

试验速览

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

•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

发起方