None listed
Conditions
Interventions
Medical Device : Intervention Name:
Transforaminal Lumbar Interbody Fusion (TLIF) using the Excender expandable cage
Type of Intervention:
Surgical implantation of a spinal interbody fusion device
D
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged =19 years Patients requiring 1–2 level TLIF between L1 and S1 for degenerative lumbar spine disease Failed =3 months of conservative treatment, with supporting radiologic findings and persistent symptoms (e.g., low back pain, leg pain) Willing to provide written informed consent and comply with scheduled visits and study procedures
Exclusion criteria
Exclusion criteria: Inmates or prisoners; pregnant or breastfeeding women Poor cartilage quality, active infections, hypersensitivity or allergy to device materials (Titanium, PEEK, Tantalum) Hemorrhagic disorders (e.g., hemophilia), immunosuppression, or preexisting infections that could delay healing Non-degenerative spinal conditions (e.g., trauma, tumor, spinal infections) Severe cardiac/liver disease, osteomalacia, Paget’s disease Uncooperative behavior, cognitive impairment, or inability to comply with follow-up Planned emigration within 2 years or otherwise deemed inappropriate by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate at 12 months postoperatively (defined by radiographic/CT fusion mass and <3° Cobb angle difference on flexion-extension view) | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Visual Analog Scale (VAS) scores for back and leg pain at 3, 6, and 12 months postoperatively compared to baseline;Improvement in Oswestry Disability Index (ODI) scores at 3, 6, and 12 months postoperatively compared to baseline;Incidence of adjacent segment degeneration (ASD) at 12 months postoperatively | — |
Countries
Korea, Republic of
Contacts
Public ContactSun-Oak Jee
Asan Medical Center
Outcome results
None listed