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

NCT07050290 | Recruiting

• 1 other identifier: NS12-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Failed Back Surgery Syndrome; Degeneration Lumbar Spine; Degenerative Spondylolisthesis; Sagittal Imbalance

Keywords

Lumbar fusion; segmental lordosis; revision spinal surgery; posterior approach

Outcome Measures

Primary Outcomes (1)

• Change from baseline in lumbar balance parameters

  To observe the change from baseline in segmental lordosis at operated level by CT, in degrees

  2 weeks postoperatively (or at day of hospital discharge)

Secondary Outcomes (9)

• Change from baseline in Numeric Pain Rating Scale

  2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

• Change from baseline in Oswestry Disability Index

  2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively

• Change from baseline in The Health Transition Item from SF-36

  2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively

• Change from baseline in lumbar balance parameters

  3 months and 12 months postoperatively

• Change from baseline in lumbar balance parameters

  3 months and 12 months postoperatively

Study Arms (1)

Cohort

OTHER

All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.

Procedure: Restoring segmental lordosis at the lumbar spine

Interventions

Restoring segmental lordosis at the lumbar spine PROCEDURE

All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Over 18 years' old;
• \. 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;
• \. 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
• \. Need for a planned surgical procedure with a major extent of segmental lordosis restoration (more than 10°);
• \. Given written informed consent;
• \. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements

You may not qualify if:

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

Sponsors & Collaborators

• N.N. Priorov National Medical Research Center of Traumatology and Orthopedics: lead

Study Sites (1)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

RECRUITING

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Aleksandr Krutko, MD, PhD

CONTACT

+7 495 744 40 11; ortho-ped@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): July 25, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

RU (1)