An interventional study of decompression and fusion in Lumbar Spinal Stenosis, Spinal Stenosis and Spinal Fusion, sponsored by Sklifosovsky Institute of Emergency Care. Recruiting at 2 sites in Russia. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Sklifosovsky Institute of Emergency Care · Not applicable, Interventional, and Treatment
Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups.
This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.
The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare the long-term clinical results of the two surgical methods (decompression vs. decompression and fusion) in patients with single-level lumbar stenosis.
This study is focused on the non-inferior clinical results of decompression compared with the standard fusion procedure. In the decompression group, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and corresponding parts of the vertebral arch are to be preserved intact. In the fusion group, decompression is to be supplemented with transforaminal interbody fusion. Participants meeting the inclusion criteria will be randomly divided into two equal groups (1:1), depending on the surgical method. The final analysis will include 86 patients (43 per group). The primary endpoint is Oswestry Disability Index dynamics at the end of the 24-month follow-up compared to the baseline level. Secondary outcomes included those estimated using the SF-36 scale, EQ-5D-5L, and psychological scales. Additional parameters will include sagittal balance of the spine, fusion results, total cost of surgery, and hospital stay followed by two-year treatment. Follow-up examinations will be performed at 3, 6, 12, and 24 months Authors suggest that this study will improve the evidence for application of various surgical techniques for lumbar spine stenosis surgery and verify the existing protocol for surgical management.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 86 is close to the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Sklifosovsky Institute of Emergency Care is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
minimally invasive decompression without fusion
Procedure: decompression
minimally invasive decompression with trans-foraminal interbody fusion
Procedure: fusion
laminotomy of the corresponding adjacent vertebrae, partial flavectomy and medial facetectomy are planned to be performed unilaterally. Depending on the surgeon's personal preferences, the following two options are available: 1) equivalent decompression procedure contralaterally and 2) crossover contralateral decompression. Irrespective of the selected option, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch must be preserved intact in all participants.
First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.
Oswestry Disability Index
The questionnaire includes 10 sections containing 6 statements each. Depending on the answer, a score is assigned (from 0 to 5). The maximum number of points is 50. After that, the points are converted into percentages (from 0 to 100%).
Time frame: 24 months
SF-36 v.1 scale (standard form)
The questionnaire contains 36 questions, grouped into 8 scales that assess physical functioning, role-playing, bodily pain, general health, vitality, social functioning, emotional state, and mental health. For each of them, the maximum score is 100 points.
Time frame: 24 months
EQ-5D-5L
The questionnaire contains 5 sections (mobility, self-care, usual activities, pain, anxiety) of three statements and the EQ-VAS visual analog pain scale. The results can be converted into a single numerical value (index) adjusted for the patient's region of residence
Time frame: 24 months
Won-Korff Chronic Pain Syndrome Assessment Scale
allows evaluating the severity of pain and its impact on life in points. Grade 0 corresponds to the absence of pain, and grade IV to the maximum limitation of life because of severe pain.
Time frame: 24 months
Pain Catastrophizing Scale
makes it possible to assess completely the psychological aspects of pain perception, in particular the exaggerated negative perception of painful stimuli. The questionnaire contains 13 questions, each of which is evaluated in points (0 points, no symptom, 4, the patient experiences these feelings all the time).
Time frame: 24 months
Chronic Pain Coping Inventory
allow one of eight scales to classify a patient's preferred strategy for coping with chronic pain.
Time frame: 24 months
scale of the American Society of Anesthesiologists ASA
This classification distinguishes 5 classes of physical status depending on the presence of concomitant diseases (Class I, healthy patient, Class V, dying).
Time frame: baseline
The cost of the treatment
The cost of hospitalization of the patient, including the performance of surgical intervention, as well as the period of the patient's incapacity for work because of spinal disease, will also be calculated. Also, within 2 years after the intervention, the cost of subsequent treatment in rehabilitation centers and other hospitals for complications of the operation or other manifestations of degenerative-dystrophic changes in the lumbar spine will be considered.
Time frame: 24 months
quality of fusion
according to CT data, the quality of fusion using the Tan criteria will be graded into one of four grades of fusion-grade I (complete fusion) to grade IV (bipolar pseudarthrosis)
Time frame: 24 months
pelvic tilt (PT)
a parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and the vertical axis. Will be evaluated on X-ray.
Time frame: 24 months
pelvic incidence (PI)
the angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head. Will be evaluated on X-ray.
Time frame: 24 months
sacral slope (SS)
the angle between the tangent line to the superior endplate of S1 and the horizontal plane. Will be evaluated on X-ray.
Time frame: 24 months
al axis displacement (SVA)
a horizontal distance between a plumb line dropped from the center of the C7 body and the posterior-superior corner of the S1 body. Will be evaluated on X-ray.
Time frame: 24 months
Plan to share: Yes — Data are available upon reasonable request in Sklifosovsky Research Institute for Emergency Medicine
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Study protocol will be available after march 2022. An interim analysis will be conducted when follow-up data is available at 12 months for at least 20 patients in each cohort. Final analysis will be presented after december 2026
Access criteria: the approval of institutional review board
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Sklifosovsky Institute of Emergency Care