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

Degeneration Spine Clinical Trial

— PSEUDOLUSE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04308018
• Other study ID #: 20/20
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: August 2023

Study information

• Verified date: March 2020
• Source: Technische Universität München
• Contact: Sandro Krieg, MD
• Phone: 8941402151
• Email: sandro.krieg[@]tum.de
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 148
• Est. completion date: August 2023
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degeneration Spine

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision rate	Revisions rates between groups 1 year after surgery	1 year after surgery
Secondary	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
Secondary	British Medical Research Council (BMRC) scale	BMRC scale 3, 6, 12, and 24 months after surgery	3, 6, 12, and 24 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction	Patient satisfaction index 3, 6, 12, and 24 months after surgery	3, 6, 12, and 24 months after surgery
Secondary	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
Secondary	Revision rate II	Revisions rates between groups 24 months after surgery	24 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Progressive degeneration of the adjacent segment	Radiological proof of progressive degeneration of the adjacent segment	3, 6, 12, and 24 months after surgery
Secondary	Surgery duration	Surgery duration	Surgery
Secondary	Intraoperative blood loss	Intraoperative blood loss	Intraoperative
Secondary	Adverse events	Adverse events	3, 6, 12, and 24 months after surgery