To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1. Pedicle screws for posterior Instrumentation and fusion of the lumbar spine plus intervertebral fusion L5/S1 (anterior lumbar inter body fusion (ALIF), transforaminal lumbar inter body fusion (TLIF), or posterior lumbar inter body fusion (PLIF)) with 1. Caudal end of the instrumentation at S1 2. Caudal end of the instrumentation at iliac bone via S2alar-iliac screws Stratification of both groups by: * Number of instrumented levels * Sagittal balance (Roussouly type 1+2 vs. 3+4) Prospective, randomized, controlled, rater-blinded multicentric interventional study with two parallel groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
148
Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
Caudal end of the instrumentation at S1
Revision rate
Revisions rates between groups 1 year after surgery
Time frame: 1 year after surgery
Inter-group Oswestry disability index (ODI)
Difference in Oswestry disability index (ODI) between groups 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
British Medical Research Council (BMRC) scale
BMRC scale 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
Severe adverse events
(Severe adverse events) SAE due to instrumentation (new neurological deficit, infection, vascular complications, etc.)
Time frame: 3, 6, 12, and 24 months after surgery
Back pain intensity
Back pain intensity at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
Health-related quality of life
Health-related quality of life evaluated by the "physical component summary (PCS)" of the short-form (SF)-36 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
Patient satisfaction
Patient satisfaction index 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
Intra-group Oswestry disability index (ODI)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Difference in ODI 3, 6, 12, and 24 months after surgery versus preoperatively within the same group
Time frame: 3, 6, 12, and 24 months after surgery
Revision rate II
Revisions rates between groups 24 months after surgery
Time frame: 24 months after surgery
Sacroiliac joint syndrome
Clinically apparent sacroiliac joint syndrome (Definition: Effective infiltration of local anesthetic) 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
Gluteal pain
Gluteal pain at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery
Time frame: 3, 6, 12, and 24 months after surgery
Changes in sagittal balance
Changes in sagittal balance (C7 plumb line, pelvic tilt, pelvic incidence, sacral slope, and lumbar lordosis) 1 and 2 years after surgery versus preoperatively within the same group
Time frame: 1 and 2 years after surgery
Progressive degeneration of the adjacent segment
Radiological proof of progressive degeneration of the adjacent segment
Time frame: 3, 6, 12, and 24 months after surgery
Surgery duration
Surgery duration
Time frame: Surgery
Intraoperative blood loss
Intraoperative blood loss
Time frame: Intraoperative
Adverse events
Adverse events
Time frame: 3, 6, 12, and 24 months after surgery