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Pain Reduction and Treatment Effectiveness of Lumbar Surgery Using a 3D Titanium Cage in Patients with Degenerative Spinal Disease

Clinical Efficacy and Pain Improvement of Oblique Lumbar Interbody Fusion Using a 3D Titanium Cage in Degenerative Spinal Diseases: A Prospective Single-Arm Observational Study with Retrospective Comparison to PEEK Cage Outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011341
Enrollment
30
Registered
2025-12-17
Start date
2026-01-16
Completion date
Unknown
Last updated
2026-01-05

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

GS Medical
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Prospective Study] 1. Adults aged 19 to 90 years at the time of enrollment 2. Patients undergoing surgery for spondylolisthesis, foraminal stenosis, spinal canal stenosis, recurrent herniated intervertebral disc after open surgery, or degenerative disc disease 3. Patients who are willing and able to participate in the study, comply with the treatment and study procedures, and attend all scheduled follow-up visits 4. Patients who have received a full explanation of the purpose, methods, and potential benefits of the study and have voluntarily provided written informed consent [Retrospective Study] 1. Patients who underwent oblique lumbar interbody fusion (OLIF) using a PEEK cage at our institution between January 1, 2022, and December 31, 2023 2. Patients with available postoperative imaging and medical records with a minimum follow-up period of 6 months 3. Patients whose medical records indicate no significant issues with communication or treatment compliance

Exclusion criteria

Exclusion criteria: [Prospective Study] 1. Patients 18 years of age or younger, or 91 years of age or older 2. Patients undergoing surgery for spinal infection or spinal tumors 3. Patients with a history of lumbar spinal fusion or intervertebral disc replacement 4. Patients with bleeding disorders 5. Patients who are uncooperative, have abnormal mental function, or alcohol dependence, and are therefore unable to continue postoperative treatment and follow-up 6. Patients with clinically significant findings that, in the opinion of the principal investigator or sub-investigator, render the patient inappropriate for participation in this study [Retrospective Study] 1. Patients who were 18 years of age or younger, or 91 years of age or older, at the time of surgery 2. Patients with severe cardiac, pulmonary, or hepatic diseases that made perioperative or postoperative outcome assessment difficult 3. Patients who underwent surgery for non-degenerative causes, such as lumbar infection or tumors 4. Patients with incomplete medical records or imaging data, preventing reliable assessment of subsidence or spinal fusion

Design outcomes

Primary

MeasureTime frame
Bone Fusion

Secondary

MeasureTime frame
Visual Analogue Scale; VAS;Oswestry Disability Index; ODI;EuroQol-5 Dimension; EQ-5D;Bone Fusion;Cage subsidence

Countries

Korea, Republic of

Contacts

Public Contactjiwon kwon

Yonsei University Health System, Gangnam Severance Hospital

kwonjjanng@yuhs.ac+82-2-2019-6199

Outcome results

None listed

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