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

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 Overview

• Status: Not yet recruiting
• Conditions: Degeneration Spine
• Intervention / Treatment: Procedure: S1 screws; Procedure: S2alar-iliac screws

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 Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandro Krieg, MD; Phone Number: 8941402151; Email: sandro.krieg@tum.de
• Study Contact Backup: Name: Sebastian Ille, MD; Phone Number: 8941402151; Email: sebastian.ille@tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: S1; Caudal end of the instrumentation at S1	Procedure: S1 screws; Caudal end of the instrumentation at S1
Active Comparator: S2alar-iliac; Caudal end of the instrumentation at iliac bone via S2alar-iliac screws	Procedure: S2alar-iliac screws; Caudal end of the instrumentation at iliac bone via S2alar-iliac screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rate	Revisions rates between groups 1 year after surgery	1 year after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Sandro Krieg, MD, Technical University Munich

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No