Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
NCT ID: NCT04308018
Last Updated: 2020-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
148 participants
INTERVENTIONAL
2020-08-31
2023-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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S1
Caudal end of the instrumentation at S1
S1 screws
Caudal end of the instrumentation at S1
S2alar-iliac
Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
S2alar-iliac screws
Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
Interventions
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S2alar-iliac screws
Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
S1 screws
Caudal end of the instrumentation at S1
Eligibility Criteria
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Inclusion Criteria
* Lumbar or thoracolumbar Instrumentation
* Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1
* Age ≥ 18 years
Exclusion Criteria
* Chronic steroid usage
* Significant co-morbidity influencing the surgical success:
* Osteoporosis
* Rheumatoid arthritis
* Mental illness/dementia
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Sandro Krieg, MD
Role: PRINCIPAL_INVESTIGATOR
Technical University Munich
Central Contacts
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Other Identifiers
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20/20
Identifier Type: -
Identifier Source: org_study_id
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