Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression

Официальное название

Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis

Обзор

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.

Вмешательства

• Процедура Isolated lumbar decomression
  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, sy

Первичные конечные точки

• Change from baseline in lumbar balance parameters [Срок оценки: 3 months postoperatively]

Вторичные конечные точки (12)

• Change from baseline in lumbar balance parameters [Срок оценки: 12 months postoperatively]
• Change from baseline in lumbar balance parameters [Срок оценки: 3 months and 12 months postoperatively]
• Change from baseline in lumbar balance parameters [Срок оценки: 3 months and 12 months postoperatively]
• Change from baseline in lumbar balance parameters [Срок оценки: 3 months and 12 months postoperatively]
• Change from baseline in lumbar balance parameters [Срок оценки: 3 months and 12 months postoperatively]
• Change in the cross-sectional area of the dural sac, mm2 [Срок оценки: 3 months after surgery]
• Change from baseline in Oswestry Disability Index [Срок оценки: 3 months and 12 months postoperatively]
• Change from baseline in Numeric Pain Rating Scale [Срок оценки: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively]
• Change from baseline in Neuropathic Pain 4 Questions [Срок оценки: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively]
• Change from baseline in The Health Transition Item from SF-36 [Срок оценки: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively]
• Change from baseline in posture alignment [Срок оценки: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively]
• Adverse Events [Срок оценки: during study, an average of 12 months]

Критерии участия

Критерии включения

• 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;
• 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.

Non-Inclusion Criteria:

• 1\. Prior any lumbar surgery;
• 2\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
• 3\. Degenerative scoliosis > 20 degrees;
• 4\. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
• 5\. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;

Критерии исключения

• 1\. Performed intraoperative discotomy;
• 2\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 3 центра

• Pirogov National Medical Surgical Center — Moscow
• Burdenko Neurosurgery Institute — Moscow
• Priorov National Medical Research Center of Traumatology and Orthopedics — Moscow

Идентификаторы

NCT: NCT07139938 · NS12-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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