None listed
Conditions
Interventions
Medical Device : For minimally invasive transforaminal lumbar interbody fusion (TLIF), a discectomy is performed using a unilateral biportal endoscopy (UBE), and a space for cage insertion is secured.
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults between the ages of 19 and 75 2. Patients with lumbar degenerative intervertebral disc disease requiring intervertebral fusion between L2 and S1 3. Patients who have heard and agreed in writing voluntarily, are willing to comply with the protocol, and are willing to visit the hospital to evaluate the observation items
Exclusion criteria
Exclusion criteria: 1) Patients with non-degenerative lumbar disorders such as spinal trauma, spinal tumors, spinal infections and inflammation, and re-operation 2) Pregnant, lactating, or pregnant women who plan to conceive or disagree with medically acceptable contraception during this trial * Medically acceptable contraception: condoms, oral contraceptives lasting at least 3 months, injections or implantation, etc 3) Malignant tumor patients within 5 years 4) Patients taking chronic steroids and corticosteroids [for example, when taking dexamethasone at a dose of 10mg per day for more than 4 weeks] 5) Those currently diagnosed with the following diseases: A)Severe heart disease or liver dysfunction B) Infectious disease, uncorrected blood clotting disorder (platelet2.0) C) Osteomalacia, Paget's disease D) Others (syphilis, severe epilepsy, alcohol/drug addiction) 6) Those who have had an allergic reaction or are sensitive to the product itself or its components, which are medical devices of this clinical trial * Raw materials for medical devices for clinical trials: titanium alloy (Ti-6AI-4VELLI)/PEEK (Polyether ether ketone)/Tantalum 7) Those who have participated in other clinical trials within the last 6 months 8) Those who are judged inappropriate for clinical trials by the principal investigator or other researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Comparison of anterior and posterior disc height of fusion segment (2) Comparison of neuroforaminal height of fusion segment (3) Comparison of segmental lordosis of upper and lower vertebral body of fusion segment | — |
Secondary
| Measure | Time frame |
|---|---|
| bone union rate, sedimentation rate;Cage breakage rate, cage migration rate;VAS (Visual Analogue Scale) score improvement rate, ODI (Oswestry Disability Index) score improvement rate;comparison of anterior and posterior disc height of fusion segment, comparison of neuroforaminal height of fusion segment, comparison of segmental lordosis of fusion segment upper and lower vertebral bodies | — |
Countries
Korea, Republic of
Contacts
Public ContactChorong Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed