Restore the lumbar curve after a prior fusion failed at the same level

Restoring Segmental Lordosis Via One Previous Posterior Approach After Failed Fusion at the Same Level for Degenerative Lumbar Disease

This will test a posterior surgical technique to restore lumbar segmental lordosis in adults with pain after a failed lumbar fusion at the same or adjacent level or with symptomatic disc disease and loss of segmental lordosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT07050290 on ClinicalTrials.gov

What this trial studies

This single-center interventional protocol uses a posterior surgical approach to restore segmental lumbar lordosis (aiming for more than 10° correction) in patients with prior failed lumbar fusion or symptomatic discopathy at L3–S1. Eligible adults have persistent back pain with or without radicular symptoms for at least three months and imaging confirming loss of segmental lordosis. Patients with removable posterior-accessible hardware and a planned major correction will undergo revision procedures and serial follow-up with clinical and radiographic outcomes. The primary focus is on technical restoration of lordosis and subsequent effects on pain, function, and fusion status.

Who should consider this trial

Good fit: Adults over 18 with persistent lumbar back pain (with or without leg symptoms), imaging-confirmed loss of segmental lordosis at L3–S1, and a need for planned revision surgery aiming for >10° restoration are ideal candidates.

Not a fit: Patients with interbody implants placed by a non-posterior approach that cannot be removed through a posterior approach or with complete interbody fusion at the target level are unlikely to benefit.

Why it matters

Potential benefit: If successful, the technique could improve spinal alignment, reduce pain, and improve function for patients needing revision surgery after a failed fusion.

How similar studies have performed: Posterior revision techniques to restore lordosis have been reported with mixed results in case series and smaller cohorts, but high-quality comparative evidence is limited.

Eligibility criteria

Inclusion Criteria:

* 1\. Over 18 years' old;
* 2\. Lumbar back pain with / without radicular leg pain (with / without neurological deficit) with / without neurogenic claudication, symptoms persisting for at least 3 months prior to surgery;
* 3\. 1) Failed back lumbar fusion surgery at the same level or on an adjacent segment or 2) Symptomatic discopathy with loss of segmental lordosis at one of the levels L3-L4, L4-L5 or L5-S1, confirmed by MRI и Rg, with/without degenerative stenosis/spondylolisthesis
* 4\. Need for a planned surgical procedure with a major extent of segmental lordosis restoration (more than 10°);
* 5\. Given written informed consent;
* 6\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements

Exclusion Criteria:

* 1\. Interbody implants previously placed via non-posterior approach at the level of surgery (which cannot be removed through the posterior approach);
* 2\. Complete interbody fusion after previous surgery at the level of surgery;
* 3\. HU values of lumbar body vertebrae less than 120 HU;
* 4\. Any contraindication or inability to undergo baseline and/or follow up MRI, CT or X-ray as required per protocol;
* 5\. Back or non-radicular pain of unknown etiology;
* 6\. History or presence of any other major neurological disease or condition that may interfere with the study assessments;
* 7\. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Where this trial is running

Moscow

• Priorov National Medical Research Center of Traumatology and Orthopedics — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Aleksandr Krutko, MD, PhD

Conditions Failed Back Surgery Syndrome; Degeneration Lumbar Spine; Degenerative Spondylolisthesis; Sagittal Imbalance; Lumbar fusion; segmental lordosis; revision spinal surgery; posterior approach