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

Degeneration Spine Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Degeneration Spine

• NCT number: NCT04308018
• Study type: Interventional
• Source: Technische Universität München
• Contact: Sandro Krieg, MD
• Phone: 8941402151
• Email: sandro.krieg@tum.de
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Completion date: August 2023