Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07050290

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, Russia, 127299

Actively Recruiting

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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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Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level | DecenTrialz