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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Priorov National Medical Research Center of Traumatology and Orthopedics
RECRUITING
Moscow
Contact Information
Primary
Aleksandr Krutko, MD, PhD
ortho-ped@mail.ru
+7 495 744 40 11
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-07-25
Participants
Target number of participants: 20
Treatments
Other: Cohort
All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.
Sponsors
Leads: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

This content was sourced from clinicaltrials.gov