Comparative evaluation on the efficacy of 3D-printed porous titanium cages compared with PEEK cages used for anterior cervical discectomy and fusion (ACDF): prospective, randomized, multi-center, clinical trial

Dongguk University Ilsan Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月2日

适应症

试验速览

暂无简介。

•(1) Patients with degenerative diseases of the cervical spine (cervical disc herniation, cervical radiculopathy, cervical spinal stenosis, cervical myelopathy, etc.) or posterior longitudinal ligament ossification do not improve symptoms despite conservative treatment for at least 6 weeks, so anterior cervical discectomy and fusion surgery are recommended.
•(2) Patients with confirmed cervical degenerative disease or posterior longitudinal ligament ossification associated with symptoms through X-ray, CT, or MRI examination
•(3) Patients who do not have communication problems when conducting clinical trials
•(4) Patients willing to participate in the trial, comply with the treatment and procedures, and visit the hospital for all follow-up evaluations.
•(5) Patients who voluntarily signed a written consent form after receiving an explanation of the purpose, method, and effects of this clinical trial

•(1) If patients are under 18 years of age or over 85 years of age
•(2) Patients who cannot undergo spinal surgery under general anesthesia due to severe heart, lung disease, liver disease, or decreased renal function
•(3) Patients undergoing surgery for cervical spine trauma, infection, or tumor
•(4) Patients who previously underwent cervical spine surgery
•(5) Patients with hemorrhagic disease
•(6) Women of childbearing age who are planning to become pregnant during this study period
•(7) Uncooperative or abnormal mental function patients or alcoholics who cannot continue treatment after surgery
•(8) In addition to the above, a person who has clinically significant findings that are deemed inappropriate for this study in the medical judgment of the test director or person in charge.

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