The spinal fusion indications and outcomes randomised trial

Not Applicable

Completed

Conditions: Spinal fusion
Surgery

Registration Number: ISRCTN15462386

Lead Sponsor: niversity of Oxford

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 6

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 <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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures