Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009267
Enrollment
80
Registered
2024-03-22
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Dongguk University Ilsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Bone union

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactJun-Young Choi

Dongguk University Ilsan Hospital

junyoung2025@gmail.com+82-31-391-7295

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026