Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine

Study Overview
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Brief Summary
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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
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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 Caudal end of the instrumentation at S1 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

Official Title
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Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine

Conditions
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Degeneration Spine

Intervention / Treatment
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* Procedure: S2alar-iliac screws
* Procedure: S1 screws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Scoliosis >20° Chronic steroid usage Significant co-morbidity influencing the surgical success: Osteoporosis Rheumatoid arthritis Mental illness/dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S1<br>Caudal end of the instrumentation at S1 | Procedure: S1 screws<br>* Caudal end of the instrumentation at S1<br>|
| Active Comparator: S2alar-iliac<br>Caudal end of the instrumentation at iliac bone via S2alar-iliac screws | Procedure: S2alar-iliac screws<br>* Caudal end of the instrumentation at iliac bone via S2alar-iliac screws<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision rate | Revisions rates between groups 1 year after surgery | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-group Oswestry disability index (ODI) | Difference in Oswestry disability index (ODI) between groups 3, 6, 12, and 24 months after surgery | 3, 6, 12, and 24 months after surgery | 
| British Medical Research Council (BMRC) scale | BMRC scale 3, 6, 12, and 24 months after surgery | 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.) | 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 | 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 | 3, 6, 12, and 24 months after surgery | 
| Patient satisfaction | Patient satisfaction index 3, 6, 12, and 24 months after surgery | 3, 6, 12, and 24 months after surgery | 
| Intra-group Oswestry disability index (ODI) | Difference in ODI 3, 6, 12, and 24 months after surgery versus preoperatively within the same group | 3, 6, 12, and 24 months after surgery | 
| Revision rate II | Revisions rates between groups 24 months after surgery | 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 | 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 | 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 | 1 and 2 years after surgery | 
| Progressive degeneration of the adjacent segment | Radiological proof of progressive degeneration of the adjacent segment | 3, 6, 12, and 24 months after surgery | 
| Surgery duration | Surgery duration | Surgery | 
| Intraoperative blood loss | Intraoperative blood loss | Intraoperative | 
| Adverse events | Adverse events | 3, 6, 12, and 24 months after surgery |