NCT04308018

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Degeneration Spine

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-08-01
• Completion: 2023-08-01
• First posted: 2020-03-13
• Last updated: 2020-03-13