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Набор по приглашению NCT06971835

INDUCE: A Prospective 2-Year Spine Registry

— Наблюдательное Subjects Treated With NMP as Part of Their Spine Surgery Degenerative Disc Disease (DDD)

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: NMP.
Кому может быть актуально
Состояния в реестре: Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD). 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

Assessment of Safety and Clinical Effectiveness of Induce NMP® in Degenerative Spine Surgery: A Prospective 2-Year Registry

Обзор

The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine. The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.

Подробное описание

This is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 US sites. All subjects who meet study entrance criteria and planned to be treated with NMP Fibers and/or Micro Particulates as part of their cervical or lumbar spinal surgery will be invited to participate in the study.

PRIMARY ENDPOINTS

* Safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s) * Effectiveness - presence of fusion as measured by x-rays and if available CT.

SECONDARY ENDPOINTS

Beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables:

* Baseline demographics and medical history * Duration of hospitalization * Operative time * Estimated blood loss * Neurological status * Subject patient reported outcomes as applicable including, but not limited to:

* Oswestry Disability Index (ODI)/ Neck Disability Index (NDI) * Visual Analog Scale (VAS) Pain * Veteran Rand 12-Item Health Survey (VR-12)

Вмешательства

  • Устройство NMP
    The study product is Induce Biologics NMP Fibers and NMP Micro Particulates however, this is observational research that involves standard of care. NMP is regulated as a human cellular or tissue-based product (HCT/P) under section 361 of the Public Health Service (PHS) Act and in 21 CFR Part 1271. Under this regulation it did not require clinical evaluation before it could be used commercially. It is indicated for use "as a bone void filler for filling voids and gaps in the skeletal system that

Первичные конечные точки

  • Fusion [Срок оценки: 6 month and 12 month post surgery, and 24 month post surgery]
  • Serious Adverse Events and Subsequent Surgical Interventions [Срок оценки: Through study completion, an average of 2 years.]
Вторичные конечные точки (3)
  • Change in Pain [Срок оценки: Baseline, 3 month, 6 months, 12 months, and 24 months postop]
  • Change in Disability [Срок оценки: Baseline, 3 month, 6 months, 12 months, and 24 months postop]
  • Change in Quality of Life [Срок оценки: Baseline, 3 month, 6 months, 12 months, and 24 months postop]

Критерии участия

Критерии включения

  • Implanted on-label with NMP in at least one vertebral level in the cervical (C1-C7) or lumbar (L1-S1) spine as part of their surgery
  • Total volume of bone graft or bone graft substitute used in index surgery must contain at least 50% NMP by volume per treated level, where NMP is mixed with other graft material.
  • Skeletally mature (age≥18 years of age)
  • Be willing to sign the study-specific informed consent document prior to index surgery

Критерии исключения

  • Not willing to sign the study-specific informed consent document prior to index surgery
  • Use of allogenic growth factor extacts (i.e. OsteoFactor/ProteiOS) or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (BMA) is allowed)
  • Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery
  • Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level
  • Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female)
  • Did not complete baseline patient reported outcomes prior to index surgery
  • Incarcerated at the time of surgery or preoperative evaluation

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 · 2 центра
  • Spine Center of Louisiana — Baton Rouge
  • Spine Institute of Louisiana — Shreveport

Идентификаторы

NCT: NCT06971835 · CT-NMP-009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗