Actively Recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Led by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Updated on 2025-07-03
20
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The restoration of lumbar lordosis is mandatory during lumbar fusion surgery for degenerative disc disease, since not restoring lumbar lordosis adequately may adversely affect surgical outcomes and the patient's quality of life in the follow-up. Revision surgery to restore segmental lordosis at the level of previous spinal fusion is extremely difficult to do and its performance is usually inferior to that of primary surgery. Need to provide a surgical technique to restore segmental lordosis via a posterior approach, which is especially important after failed previous fusion at the same lumbar level.
CONDITIONS
Official Title
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Lumbar back pain with or without leg pain or neurological symptoms lasting at least 3 months before surgery
- Failed back lumbar fusion surgery at the same or adjacent level, or symptomatic disc disease with loss of lordosis at L3-L4, L4-L5, or L5-S1 confirmed by MRI or other imaging
- Planned surgery requiring major restoration of segmental lordosis (more than 10 degrees)
- Provided written informed consent
- Able and willing to comply with study protocol and follow-up schedule
You will not qualify if you...
- Interbody implants placed by non-posterior approach at surgery level that cannot be removed posteriorly
- Complete fusion at surgery level from previous surgery
- Bone density (HU values) of lumbar vertebrae less than 120 HU
- Unable or contraindicated to undergo MRI, CT, or X-ray as required
- Back or non-radicular pain with unknown cause
- Presence or history of major neurological diseases affecting study assessments
- Previous or current enrollment in this or another study concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, Russia, 127299
Actively Recruiting
Research Team
A
Aleksandr Krutko, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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