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Набор по приглашению NCT06415123

Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft

— Наблюдательное Degenerative Disc Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MagnetOs Flex Matrix.
Кому может быть актуально
Состояния в реестре: Degenerative Disc Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)

Обзор

The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.

Подробное описание

This is a prospective, randomized, multi-center study that intends to demonstrate the performance of MagnetOs Flex Matrix compared to Cellular Allograft in patients with leg pain and/or back pain requiring up to four-level instrumented PLF surgery.

Вмешательства

  • Устройство MagnetOs Flex Matrix
    MagnetOsTM Flex Matrix is a resorbable and osteoconductive bone graft for the repair of bony defects.

Первичные конечные точки

  • Posterolateral side fusion [Срок оценки: 12 months post surgery]
Вторичные конечные точки (4)
  • Posterolateral lumbar/thoraco-lumbar fusion [Срок оценки: 6 months post surgery]
  • Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI) [Срок оценки: 12 months post-surgery]
  • Secondary Surgical Interventions (SSI's) [Срок оценки: 12 months post-surgery]
  • Clinical outcome via neck visual analog scale (VAS) [Срок оценки: 12 months post-surgery]

Критерии участия

Критерии включения

  • Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
  • Male or female patient ≥ 18 years old.
  • Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1).
  • Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.

Критерии исключения

  • Requires greater than four-level fusion or expected to need secondary intervention within one year following surgery.
  • Had prior PLF fusion or attempted PLF fusion at the involved levels.
  • Had previous decompression at the involved levels.
  • Women who are or intend to become pregnant within the next 12 months.
  • To treat conditions in which general bone grafting is not advisable.
  • In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).
  • In case of significant vascular impairment proximal to the graft site.
  • In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
  • In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
  • When intraoperative soft tissue coverage is not planned or possible.
  • Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
  • Receiving treatment with medication interfering with calcium metabolism.
  • Has leg pain, and/or back pain related to benign or malignant tumor.
  • Has history or presence of active malignancy.
  • Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
  • Is involved in active litigation relating to his/her spinal condition.
  • Has participated in an investigational study within 30 days prior to surgery for study devices

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Michigan Orthopaedic Surgeons — Southfield

Идентификаторы

NCT: NCT06415123 · CT-003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗