Clinical trial NCT04308018: Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
Official title: Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degeneration Spine
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Revision rate
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Inter-group Oswestry disability index (ODI)
timeFrame: 3, 6, 12, and 24 months after surgery
measure: British Medical Research Council (BMRC) scale
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Severe adverse events
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Back pain intensity
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Health-related quality of life
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Patient satisfaction
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Intra-group Oswestry disability index (ODI)
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Revision rate II
timeFrame: 24 months after surgery
measure: Sacroiliac joint syndrome
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Gluteal pain
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Changes in sagittal balance
timeFrame: 1 and 2 years after surgery
measure: Progressive degeneration of the adjacent segment
timeFrame: 3, 6, 12, and 24 months after surgery
measure: Surgery duration
timeFrame: Surgery
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Adverse events
timeFrame: 3, 6, 12, and 24 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Technical University Munich
name: Sandro Krieg, MD
role: PRINCIPAL_INVESTIGATOR
References: