Evaluation of the efficacy and safety of 3D printing porous titanium cage with Non-Window type versus Window type in lumbar interbody fusion

Evaluation of the efficacy and safety of 3D printing porous titanium cage with Non-Window type versus Window type in lumbar interbody fusion: A prospective, randomized, multicenter trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005793

Enrollment

Registered

2021-01-19

Start date

2020-09-22

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

None listed

Interventions

Medical Device : Before surgery, patients are randomly assigned to group 1 or group 2. For patients assigned to group 1, NW-3d cages are inserted on both left and right sides, and for patients assigne

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients with degenerative spinal diseases of the lumbar spine and need single-segment interbody fusion because there is no symptom improvement even after conservative treatment for at least 6 weeks ? Patients with confirmed spinal degenerative diseases related to symptoms by X-ray and MRI examination ? Patients with no communication problems in conducting and conducting clinical research ? Patients who participate in the test, observe treatment and procedures, and are willing to visit the hospital for all follow-up evaluation ? Patients who voluntarily agree to participate in clinical research and are willing to comply with the subject matters

Exclusion criteria

Exclusion criteria: ? Patients under 18 years of age or over 80 years of age ? Patients unable to perform spinal surgery under general anesthesia due to severe heart, lung disease, liver disease, and kidney function decline ? Patients scheduled for surgery due to spinal infection or tumor within 12 months from registration ? Those who take drugs that may affect bone union immediately before or after surgery (eg, steroids, parathyroid hormone, etc.) ? Patients whose remaining life expectancy is less than 1 year ? Patients in the age group who are pregnant and planning to become pregnant during the study period ? Patients who are not suitable for this clinical study in the opinion of the researcher or who may increase the risk associated with participation in the study

Design outcomes

Primary

Measure	Time frame
Oswestry Disability Index; ODI	—

Secondary

Measure	Time frame
bone union;Cage Subsidence;Visual Analogue Scale; VAS;EQ-5D Health Survey; EQ-5D-5L	—

Countries

Korea, Republic of

Contacts

Public ContactJeongik Lee

Chung-Ang Univerisity Hospital

liebe9060@naver.com+82-2-6299-3101

Outcome results