Status:

UNKNOWN

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

Lead Sponsor:

Technical University of Munich

Conditions:

Degeneration Spine

Eligibility:

All Genders

18+ years

Phase:

NA

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 pl...

Eligibility Criteria

Inclusion

  • 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

  • Scoliosis \>20°
  • Chronic steroid usage
  • Significant co-morbidity influencing the surgical success:
  • Osteoporosis
  • Rheumatoid arthritis
  • Mental illness/dementia

Key Trial Info

Start Date :

August 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2023

Estimated Enrollment :

148 Patients enrolled

Trial Details

Trial ID

NCT04308018

Start Date

August 1 2020

End Date

August 1 2023

Last Update

March 13 2020

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