CLUBE (UBE Stability / Dynamic Radio)

Официальное название

Assessment of Spinal Stability by Dynamic Radiography After Unilateral Biportal Endoscopic Lumbar Decompression Surgery

Обзор

Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred. Traditionally, a simple lumbar recalibration operation is preferred (bilateral laminectomy decompression), but this may affect spinal stability. In cases of spondylolisthesis or preoperative instability, lumbar fusion (arthrodesis) is sometimes necessary to avoid the risk of major instability, but such an operation is not without risk and may require repeat surgery. The development of new surgical techniques such as uni or bilateral laminotomies, which are less radical, has made it possible to avoid some arthrodeses. Nowadays, the emergence of new surgical techniques such as endoscopy has further reduced the risk of destabilization (shorter post-operative convalescence, less atrophy of the paraspinal muscles) and improved surgeon comfort (better vision and easier instrument handling). Unilateral biportal endoscopy (UBE) is one of two endoscopic techniques and has proven its effectiveness for lumbar decompression in terms of clinical benefits. However, there is no scientific evidence on spinal stability after recalibration under UBE. We believe that minimizing invasiveness with UBE during simple lumbar recalibration surgery can preserve spinal stability, thereby reducing the need for lumbar fixation and lowering the cost of care. We therefore propose to study the maintenance of spinal stability using dynamic radiography at 3 months post-operatively in patients undergoing lumbar recalibration surgery with UBE.

Подробное описание

Spinal stability is defined by the absence of abnormal mobility (sagittal translation of at least 3 mm) between flexion and extension movements and will be assessed on the 3-months postoperative dynamic radiography.

Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.

Вмешательства

• Другое Postoperative dynamic radiography
  Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability

Первичные конечные точки

• Spinal stability rate [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Spondylolisthesis rate [Срок оценки: 3 months]
• Perioperative complications rate [Срок оценки: 1 day]
• Oswestry Disability index evaluation [Срок оценки: 3 months]
• Pain evaluation [Срок оценки: 3 months]
• Vertebral mobility evaluation [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patient ≥ 50 ans,
• Patient requiring single-level or 2-levels lumbar decompression surgery under UBE,
• Patients who underwent dynamic radiography within 3 months prior to surgery,
• Patient who received information on the study and who signed the consent form.

Критерии исключения

• Presence of a mobile spondylolisthesis with a ≥ 3 mm difference between flexion and extension movements on preoperative dynamic radiography,
• Patient with history of lumbar arthrodesis,
• Patient not available for study follow-up.

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

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Clinique St Jean Sud de France — Montpellier

Идентификаторы

NCT: NCT06904326 · 2025-A00134-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗