Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorN.N. Priorov National Medical Research Center of Traumatology and Orthopedics

About this trial

Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 45 and over;

2. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis with/without spodylolisthesis, confirmed by MRI;

3. Planned isolated decompression of the spinal canal without implantation of any devices;

4. Symptoms persisting for at least 3 months prior to surgery;

Disqualifiers

1. Performed intraoperative discotomy;

2. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)

Trial design

Design model

Single group

Treatments tested in this trial

  • Isolated lumbar decomression

    Procedure/Surgery

    All patients will undergo microsurgical decompression of stenosed neural structures of the lumbar canal at all clinically significant levels with saving the posterior spinal column (type of decompression may be as unilateral, bilateral, or bilateral from a unilateral approach (over-the-top)), including endoscopic decompression. Degenerative lumbar stenosis may be caused by thickened yellow and posterior longitudinal ligaments, facet joints hypertrophy, vertebral body osteophytes posteriorly, synovial (facet joints cysts) and disc cysts.

Treatment groups

165 Participants
are divided into 1 treatment group
Group A: CohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in lumbar balance parameters

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

Time frame
3 months postoperatively

Secondary outcomes

1

Change from baseline in lumbar balance parameters

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

Time frame
12 months postoperatively
2

Change from baseline in lumbar balance parameters

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

Time frame
3 months and 12 months postoperatively
3

Change from baseline in lumbar balance parameters

To observe the change from baseline in lumbar lordosis (L1-S1) by full body X-Ray, in degrees

Time frame
3 months and 12 months postoperatively
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Lead sponsor

Burdenko Neurosurgery Institute

Collaborator

Pirogov National Medical Surgical Center

Collaborator