Investigation of DEXA-C Anterior Cervical Interbody System

Официальное название

A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System

Обзор

FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.

Подробное описание

The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. Device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach. The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better understanding of outcomes associated with it.

Вмешательства

• Устройство DEXA-C Cervical Interbody System
  The Dexa-C Cervical Interbody System is intended for use on patients who require anterior cervical discectomy and fusion surgery. The system implants an interbody spacer(s) into the cervical intervertebral body space(s) to stabilize and fuse the level(s). Allograft will be used in the spacer and the spinal segment(s) are fixed with an anterior cervical plate

Первичные конечные точки

• Fusion Assesment [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Subsidence [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Must already be scheduled or planned for anterior cervical discectomy and fusion using the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone meeting on-label criteria.
• Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
• Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
• Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
• At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).

Критерии исключения

• History of cervical spine surgery less than 12 months prior to surgery.
• Diagnosis of severe spondylosis.
• Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
• Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• UCI Center for Clinical Research — Orange
• Orthopaedic Institute of Western KY — Paducah
• Koga Neurosurgery — Covington
• Optima Orthopedics — Oklahoma City

Идентификаторы

NCT: NCT05883436 · 01-AUR-DEXA-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗