Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis

Официальное название

Comparative Study Between Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis

Обзор

Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord. Laminectomy with lateral mass fixation is another option of management.

Подробное описание

Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord.

Laminoplasty is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis, particularly those with accompanying spinal instability or degenerative changes, may not achieve satisfactory outcomes with laminoplasty alone. In such cases, lateral mass fixation is often added to provide supplemental stability to the spine, potentially preventing postoperative deformities and enhancing long-term outcomes

Lateral mass fixation is often combined with posterior decompression and typically done as part of a posterior cervical fusion where screws are placed into the lateral masses (bony structures on the sides of the vertebrae) to stabilize the cervical spine after decompression, such as through a laminectomy. This procedure sacrifices some motion for stability.

A comparative study is needed to better understand the advantages and disadvantages of each approach, in order to guide clinical decision-making and improve patient outcomes.

The general aim is to evaluate and compare the clinical outcomes, safety, and effectiveness of both surgical techniques in managing this condition.

The specific aim is to compare the clinical efficacy, assess the radiological outcomes, evaluate the surgical and postoperative complication and investigate long-term outcomes and instability.

Вмешательства

• Процедура Laminoplasty
  Is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis
• Процедура Laminectomy with lateral mass fixation
  Posterior cervical decompression with lateral mass screw insertion

Первичные конечные точки

• Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function) [Срок оценки: Baseline and 6 months postoperatively]

Вторичные конечные точки (2)

• Complication rate within 90 days postoperatively [Срок оценки: Within 90 days postoperatively]
• Length of hospital stay (days) [Срок оценки: Perioperative period]

Критерии участия

Критерии включения

• Patients aged 40 ≥ years with clinically significant cervical canal stenosis (based on imaging and neurological symptoms).
• Surgical indication for cervical decompression.
• Adequate follow up data (minimum 1 year).
• Patients fit for surgery.

Критерии исключения

• Patients unfit for surgery or contraindication to general anaesthesia.
• Congenital deformities or significant spinal deformities unrelated to stenosis.
• Patients with cervical kyphosis, active infection or known allergy to titanium.
• Previous cervical spine surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• https://www.asianspinejournal.org/journal/view.php?doi=10.4184%2Fasj.2016.10.3.536

Идентификаторы

NCT: NCT07177651 · Posterior cervical approaches

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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