Actively Recruiting
Restoring Segmental Lordosis Via One Previous Posterior Approach After Failed Fusion at the Same Level for Degenerative Lumbar Disease
Led by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Updated on 2025-07-03
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a surgical technique to restore segmental lumbar lordosis via a posterior approach in patients with degenerative lumbar disease who have had a failed previous lumbar fusion at the same level. It addresses the difficulty and poorer outcomes associated with revision surgeries that try to restore lordosis after failed fusions. Restoring lumbar lordosis properly is important as inadequate restoration may negatively impact surgical results and patients' quality of life during follow-up. All participants will undergo surgery to restore segmental lordosis using one previous posterior approach after a failed fusion at the same lumbar level. This procedure targets patients with failed back lumbar fusion surgery or symptomatic discopathy involving loss of segmental lordosis at specific lumbar spine levels (L3-L4, L4-L5, or L5-S1). The study focuses on patients requiring a major restoration of segmental lordosis exceeding 10 degrees. Participants will be evaluated before surgery and followed up for about 12 months to monitor changes in lumbar balance parameters, pain levels using the Numeric Pain Rating Scale, disability via the Oswestry Disability Index, and quality of life through the Health Transition Item from SF-36. Assessments occur at 2 weeks (or hospital discharge), 3 months, and 12 months postoperatively. Safety will be monitored through tracking adverse events during the study period. Participants must comply with the protocol and follow-up schedule throughout the study.
CONDITIONS
Brief 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 discopathy with loss of segmental lordosis at L3-L4, L4-L5, or L5-S1 confirmed by MRI or X-ray
- Planned surgery requiring major restoration of segmental lordosis (more than 10 degrees)
- Provided written informed consent
- Able and willing to follow the clinical protocol and follow-up schedule
You will not qualify if you...
- Interbody implants previously placed via non-posterior approach at the surgery level that cannot be removed through the posterior approach
- Complete interbody fusion after previous surgery at the surgery level
- Lumbar vertebrae bone density (HU values) less than 120 HU
- Contraindication or inability to have baseline or follow-up MRI, CT, or X-ray as required
- Back or non-radicular pain of unknown cause
- History or presence of major neurological diseases interfering with assessments
- Previous or current enrollment in this study or plans to enroll in another study simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until hospital discharge
Participants undergo surgery to restore segmental lordosis via one previous posterior approach after a failed fusion at the same level, followed by immediate care after the procedure.
1 surgery visit and approximately 1 post-operative visit
Duration - Up to 12 months
Participants are monitored for changes in lumbar balance, pain, disability, health status, and adverse events after surgery.
Visits at 2 weeks (or hospital discharge), 3 months, and 12 months postoperatively
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
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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