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Набор по приглашению NCT06000319

Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

— Наблюдательное Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis

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: Natural Matrix Protein (NMP) Fibers, Lumbar interbody fusion, Cervical interbody fusion.
Кому может быть актуально
Состояния в реестре: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis. 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

Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Обзор

The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.

Подробное описание

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires.

The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria.

There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Вмешательства

  • Биопрепарат Natural Matrix Protein (NMP) Fibers
    human bone allograft
  • Процедура Lumbar interbody fusion
    Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
  • Процедура Cervical interbody fusion
    Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.

Первичные конечные точки

  • Incidence of interbody fusion [Срок оценки: Baseline to 12 months post-operative]
  • Incidence of secondary surgical intervention [Срок оценки: Baseline to 12 months post-operative]
  • Incidence of Adverse Product Related Events [Срок оценки: Baseline to 12 months post-operative]
Вторичные конечные точки (7)
  • Incidence of bridging bone [Срок оценки: Baseline to 12 months post-operative]
  • Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index [Срок оценки: Baseline to 12 months post-operative]
  • Change in disability score for cervical fusion patients assessed by Neck Disability Index [Срок оценки: Baseline to 12 months post-operative]
  • Change in back pain in lumbar fusion patients [Срок оценки: Baseline to 12 months post-operative]
  • Change in leg pain in lumbar fusion patients [Срок оценки: Baseline to 12 months post-operative]
  • Change in neck pain in cervical fusion patients [Срок оценки: Baseline to 12 months post-operative]
  • Change in arm pain in cervical fusion patients [Срок оценки: Baseline to 12 months post-operative]

Критерии участия

Критерии включения

  • Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
  • Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
  • Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
  • Subject must be 18 years of age or older at the time of consent;
  • Subject must be willing and able to sign an informed consent document;
  • Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.

Критерии исключения

  • Subject is under 18 years of age at the time of consent;
  • Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
  • Subject is currently imprisoned.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Alabama Back Institute — Jasper

Идентификаторы

NCT: NCT06000319 · CT-NMP-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗