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

Not Applicable

Conditions: Diseases of the musculoskeletal system and connective tissue

Registration Number: KCT0009267

Lead Sponsor: Dongguk University Ilsan Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

(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

Exclusion Criteria

(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.

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone union

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale, Neck disability index, Case subsidence, Radiologica parameters, 12-item short form health survey, Japanese orthopedic association score