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Набор скоро начнётся NCT07020000

The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode

— Наблюдательное Transforaminal Lumbar Interbody Fusion Surgery

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: Device: Nerve Cuff and Retractor System.
Кому может быть актуально
Состояния в реестре: Transforaminal Lumbar Interbody Fusion Surgery. Базовые параметры: 22 лет — 80 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 Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery

Обзор

The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures. The primary objectives are: * To evaluate the safety of the EARP surgical technique and devices during LIF surgeries. * To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.

Подробное описание

This multi-center post-marketing study will include consecutive patients who meet eligibility criteria, are scheduled to undergo a LIF procedure using the EARP Interbody System and EARP Nerve Cuff Electrode, and agree to participate. The study will include patients deemed appropriate for the procedure per the site's judgment, which may include patients with off-label use of the devices. Patients who consent to study participation and meet study criteria will undergo surgery according to site standard procedure. The EARP Nerve Cuff Electrode will be used to monitor nerve roots during surgery. Radiographic imaging will document the fusion status and various disk space parameters, and the Oswestry Disability Index (ODI) will be used to assess function and pain. Data will be collected from standard site follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery. Economic data will be collected to quantify the economics of the EARP Interbody System for LIF procedures.

Вмешательства

  • Устройство Device: Nerve Cuff and Retractor System
    Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and an EARP Retractor system to safely monitor lumbar nerve root activity and function during standard interbody fusion surgeries.

Первичные конечные точки

  • Radiographic measurements prior to surgery and at follow-up visits [Срок оценки: From enrollment until the end of follow-up at 12 months]
  • To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries [Срок оценки: From surgery until the end of follow up at 12 months]
Вторичные конечные точки (3)
  • Assess the ability of the EARP fusion system to reduce pain and restore function [Срок оценки: Baseline to final follow-up visit at 12 months]
  • Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode [Срок оценки: During Surgery]
  • Quantify health economic factors associated with the EARP fusion system for LIF procedures [Срок оценки: From surgery to end of follow up at 12 months]

Критерии участия

Критерии включения

  • Undergoing LIF between L2-S1

Критерии исключения

  • BMI >40 kg/m2
  • Pregnant or plans on becoming pregnant in the near future
  • Surgery requires combination of EARP with another lumbar interbody fusion technique (PLIF, TLIF, ALIF, OLIF, LLIF) or posterolateral fusion at another level
  • History of lumbar interbody pseudoarthrosis at planned operative level
  • Lumbar spondylolisthesis ≥ grade 3
  • Osteoporotic vertebral compression fracture treated or untreated at planned operative site
  • History of lumbar spinal metastasis
  • Acute lumbar spine trauma requiring immediate intervention
  • Owestry Disability Index (ODI) 81-100%
  • Presence of personality disorder or major psychiatric illness
  • History of allergy to titanium, platinum, PEEK, aluminum, stainless steel or silicone
  • Any additional factor that makes the patient an unsuitable candidate for the study in the opinion of the principal investigator

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 · 3 центра
  • Northwell/Phelps — Sleepy Hollow
  • Rothman Orthopaedic Institute — Philadelphia
  • Alleghany Health Network — Pittsburgh

Идентификаторы

NCT: NCT07020000 · EARP-2-1002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗