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

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Failed Back Surgery Syndrome Degeneration Lumbar Spine Degenerative Spondylolisthesis Sagittal Imbalance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change from baseline in lumbar balance parameters

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

Time frame: 2 weeks postoperatively (or at day of hospital discharge)

Secondary Outcomes

Change from baseline in Numeric Pain Rating Scale

To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)

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

Change from baseline in Oswestry Disability Index

To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active)

Time frame: 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

To observe the The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'')

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

Change from baseline in lumbar balance parameters

To observe the change from baseline in segmental lordosis at operated level by full body X-Ray, in degrees

Time frame: 3 months and 12 months postoperatively

Change from baseline in lumbar balance parameters

To observe the change from baseline in low lumbar lordosis (L4-S1) by full body X-Ray, in degrees

Time frame: 3 months and 12 months postoperatively

Change from baseline in lumbar balance parameters

To observe the change from baseline in sagittal vertical axis by full body X-Ray, in degrees

Time frame: 3 months and 12 months postoperatively

Change from baseline in lumbar balance parameters

To observe the change from baseline in full balance integrated index by full body X-Ray, in degrees

Time frame: 3 months and 12 months postoperatively

Change from baseline in lumbar balance parameters

To observe the interbody fusion grade by CT , grades by Tan

Time frame: 12 months postoperatively

Adverse Events

Document Adverse Events (incl. adverse events related to device) occurrence throughout the study

Time frame: during study, an average of 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts