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

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).