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

Technical University of Munich

Status: Unknown

Conditions: Degeneration Spine

Treatments: Procedure: S1 screws; Procedure: S2alar-iliac screws

Study type: Interventional

Funder types: Other

Identifiers

NCT04308018

20/20

Details and patient eligibility

About

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.

Full 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

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

S1

Active Comparator group

Description:

Caudal end of the instrumentation at S1

Treatment:

Procedure: S1 screws

S2alar-iliac

Active Comparator group

Description:

Caudal end of the instrumentation at iliac bone via S2alar-iliac screws

Treatment:

Procedure: S2alar-iliac screws