Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT04308018
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
Study:
NCT04308018
Study Brief:
Protocol Section:
NCT04308018