None listed
Conditions
Interventions
Medical Device : To compare the clinical and radiological outcomes in patients undergoing Posterior Lumbar Interbody Fusion (PLIF) using 3D-printed metal cages versus PEEK cages.
1) Experimental Group
Sponsors
Dongguk University Ilsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older. 2. Patients undergoing surgery for one of the following conditions: • Spondylolisthesis • Foraminal stenosis • Spinal canal stenosis • Recurrent disc herniation after open surgery • Degenerative disc disease 3. Patients who are willing to comply with the treatments and procedures involved in the study, and who are willing to visit the hospital for all follow-up and evaluation visits. 4. Patients who, after being informed about the purpose, methods, and potential effects of this clinical trial, voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects aged 18 years or younger, or 85 years or older. 2. Patients with spinal infection or spinal tumors. 3. Patients with Kümmel disease resulting from past osteoporotic vertebral fractures. 4. Patients who have previously undergone thoracolumbar spinal fusion surgery. 5. Patients with hemorrhagic disorders, cirrhosis, or end-stage renal failure on dialysis; patients with neuromuscular disease. 6. Patients who are noncooperative or have impaired mental function such that they cannot continue treatment postoperatively; patients with alcoholism. 7. Other subjects judged by the principal investigator or the responsible physician to have clinically significant conditions that make them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Fusion Assessment- Evaluation Method 1: Lateral Flexion-Extension Radiographs Segmental Motion**: =5° Translation**: =3 mm - Evaluation Method 2: Computed Tomography (CT) Imaging** Bone Bridge Formation: Presence of continuous trabecular bone bridging between adjacent vertebral endplates at the surgical site. Fusion Determination: Fusion is confirmed if both Evaluation Method 1 and Evaluation Method 2 criteria are met. | — |
Secondary
| Measure | Time frame |
|---|---|
| the cage subsidence rate will be assessed by X-ray imaging. – The subsidence rate is defined as the proportion of patients, among all study participants, determined to have subsidence at the 12-month time point. – Evaluation method: Using Marchi’s criteria, subsidence is defined when the collapse (settling) of the cage height is **= 25%** between the postoperative and 12-month images. In such cases, subsidence is declared and further categorized by grade.;Plain radiographs will be obtained at 1, 6, and 12 months post-operatively to compare and evaluate the following parameters. Lumbar lordosis angle, Spondylolisthesis [mm], Grade 0–2, Index level segmental angle [neutral] / Fusion angle, Index level segmental motion[extension-flexion], Pelvic tilt angle, Pelvic incidence angle, PI-LL angle, Sagittal vertical axis [SVA];Complication Assessment• Adjacent segment disease (ASD) • Hematoma • Seroma • Incidental dural tear • Incidental nerve root injury • Surgical site infection • Neurologic deficit • Instrument failure (screw loosening, rod fracture);Clinical Evaluations - Visual Analogue Scale (VAS) for back and leg pain - Oswestry Disability Index (ODI) - JOABPEQ (Japanese Orthopaedic Association Back Pain Evaluation Questionnaire) score | — |
Countries
Korea, Republic of
Contacts
Public ContactBonu jo
Dongguk University Ilsan Hospital
Outcome results
None listed