None listed
Conditions
Interventions
Medical Device : The medical devices used in this clinical trial include a 3D printed metal cage (test group) and a polymer PEEK cage (control group). Typically, PEEK polymer cages are machined from P
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with degenerative lumbar diseases (spondylolisthesis, spinal stenosis, recurrent disc herniation) who require fusion surgery of less than 3 segments due to spinal instability 2. Patients who participate in the trial, comply with treatments and procedures, and are willing to visit the hospital for all follow-up assessments 3. Patients who voluntarily signed a written informed consent form after receiving an explanation of the purpose, method, and effect of this study
Exclusion criteria
Exclusion criteria: 1. Patients with active spinal infection and malignant and metastatic spinal tumors (except for asymptomatic spinal simple benign tumors – neursheath, vertebral body cavernous hemangiomas, etc.) 2. Patients with a history of surgical treatment for osteoporotic spinal fracture in the past 3. Patients with severe osteoporosis (mean T-score less than -3.5) or patients with Cummel's disease 4. Patients with a history of thoracic lumbar fusion surgery in the past 5. Patients with hemorrhagic disease, patients with severe cirrhosis of the liver and patients undergoing dialysis due to chronic renal failure, and patients with neuromuscular disease 6. Uncooperative or abnormal patients with abnormal mental function who cannot continue treatment after surgery, alcoholics 7. In addition to the above, a person who has a clinically significant finding that the principal investigator or person in charge of the study is medically judged to be inappropriate for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of bone fusion through postoperative CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient pain level (Visual Analogue Scale, VAS);Oswestry Disability Index (ODI);Confirmation of cyst formation;Cage Subsidence Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactCho-rong Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed