Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
- Conditions
- Degeneration Spine
- Interventions
- Procedure: S1 screwsProcedure: S2alar-iliac screws
- Registration Number
- NCT04308018
- Lead Sponsor
- Technical University of Munich
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 148
- Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1
- Lumbar or thoracolumbar Instrumentation
- Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
- Age ≥ 18 years
-
Scoliosis >20°
-
Chronic steroid usage
-
Significant co-morbidity influencing the surgical success:
- Osteoporosis
- Rheumatoid arthritis
- Mental illness/dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S1 S1 screws Caudal end of the instrumentation at S1 S2alar-iliac S2alar-iliac screws Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
- Primary Outcome Measures
Name Time Method Revision rate 1 year after surgery Revisions rates between groups 1 year after surgery
- Secondary Outcome Measures
Name Time Method Progressive degeneration of the adjacent segment 3, 6, 12, and 24 months after surgery Radiological proof of progressive degeneration of the adjacent segment
Health-related quality of life 3, 6, 12, and 24 months after surgery 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
Sacroiliac joint syndrome 3, 6, 12, and 24 months after surgery Clinically apparent sacroiliac joint syndrome (Definition: Effective infiltration of local anesthetic) 3, 6, 12, and 24 months after surgery
Surgery duration Surgery Surgery duration
Inter-group Oswestry disability index (ODI) 3, 6, 12, and 24 months after surgery Difference in Oswestry disability index (ODI) between groups 3, 6, 12, and 24 months after surgery
British Medical Research Council (BMRC) scale 3, 6, 12, and 24 months after surgery BMRC scale 3, 6, 12, and 24 months after surgery
Intra-group Oswestry disability index (ODI) 3, 6, 12, and 24 months after surgery Difference in ODI 3, 6, 12, and 24 months after surgery versus preoperatively within the same group
Revision rate II 24 months after surgery Revisions rates between groups 24 months after surgery
Intraoperative blood loss Intraoperative Intraoperative blood loss
Severe adverse events 3, 6, 12, and 24 months after surgery (Severe adverse events) SAE due to instrumentation (new neurological deficit, infection, vascular complications, etc.)
Back pain intensity 3, 6, 12, and 24 months after surgery 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
Gluteal pain 3, 6, 12, and 24 months after surgery Gluteal pain at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery
Changes in sagittal balance 1 and 2 years after surgery 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
Patient satisfaction 3, 6, 12, and 24 months after surgery Patient satisfaction index 3, 6, 12, and 24 months after surgery
Adverse events 3, 6, 12, and 24 months after surgery Adverse events