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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2021

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

Interventions

  • Procedure: S2alar-iliac screws
    • Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
  • Procedure: S1 screws
    • Caudal end of the instrumentation at S1

Arms, Groups and Cohorts

  • Active Comparator: S1
    • Caudal end of the instrumentation at S1
  • Active Comparator: S2alar-iliac
    • Caudal end of the instrumentation at iliac bone via S2alar-iliac screws

Clinical Trial Outcome Measures

Primary Measures

  • Revision rate
    • Time Frame: 1 year after surgery
    • Revisions rates between groups 1 year after surgery

Secondary Measures

  • Inter-group Oswestry disability index (ODI)
    • Time Frame: 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
    • Time Frame: 3, 6, 12, and 24 months after surgery
    • BMRC scale 3, 6, 12, and 24 months after surgery
  • Severe adverse events
    • Time Frame: 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
    • Time Frame: 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
  • Health-related quality of life
    • Time Frame: 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
  • Patient satisfaction
    • Time Frame: 3, 6, 12, and 24 months after surgery
    • Patient satisfaction index 3, 6, 12, and 24 months after surgery
  • Intra-group Oswestry disability index (ODI)
    • Time Frame: 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
    • Time Frame: 24 months after surgery
    • Revisions rates between groups 24 months after surgery
  • Sacroiliac joint syndrome
    • Time Frame: 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
  • Gluteal pain
    • Time Frame: 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
    • Time Frame: 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
  • Progressive degeneration of the adjacent segment
    • Time Frame: 3, 6, 12, and 24 months after surgery
    • Radiological proof of progressive degeneration of the adjacent segment
  • Surgery duration
    • Time Frame: Surgery
    • Surgery duration
  • Intraoperative blood loss
    • Time Frame: Intraoperative
    • Intraoperative blood loss
  • Adverse events
    • Time Frame: 3, 6, 12, and 24 months after surgery
    • Adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technical University of Munich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sandro Krieg, MD, Principal Investigator, Technical University Munich
  • Overall Contact(s)
    • Sandro Krieg, MD, 8941402151, sandro.krieg@tum.de

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