None listed
Conditions
Interventions
Procedure/Surgery : This study includes patients with lumbar spondylolisthesis who require surgical treatment. Surgical intervention is performed according to one of three techniques: conventional ope
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled to undergo transforaminal lumbar interbody fusion (TLIF) for single-level lumbar spondylolisthesis will be eligible for inclusion if they meet the following criteria: 1) Adults aged =19 years and <80 years. 2) Patients diagnosed with lumbar spondylolisthesis requiring single-level TLIF between L2 and S1. 3) Patients who have received a full explanation of the purpose and methods of this clinical study, voluntarily provide written informed consent, demonstrate willingness to comply with the study protocol, and agree to attend scheduled hospital visits for assessment of study outcomes.
Exclusion criteria
Exclusion criteria: The following patients will be excluded from the study: 1)Patients with non-degenerative lumbar disorders such as spinal trauma, spinal tumors, spinal infection or inflammatory disease, as well as those undergoing revision surgery. 2) Pregnant or breastfeeding women, or women of childbearing potential who are planning pregnancy during the study period. 3) Patients with a history of malignancy within the past 5 years. 4) Patients receiving chronic steroid or corticosteroid therapy (e.g., dexamethasone =10 mg/day for more than 4 weeks). 5) Patients currently diagnosed with any of the following conditions: a) Severe cardiac disease or significant hepatic dysfunction b) Active infectious disease or uncorrected coagulopathy (platelet count 2.0) c) Osteomalacia or Paget’s disease d) Other conditions, including syphilis, severe epilepsy, or alcohol/drug abuse 6) Patients who have participated in another clinical trial within the past 6 months. 7) Patients deemed inappropriate for participation in this clinical study by the principal investigator or other investigators. 8) Patients in a poor general condition that may adversely affect healing capacity or recovery period, including those who are frail, have significant psychiatric disorders, or suffer from alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of surgical magnitude and invasiveness among the three surgical techniques will be performed by evaluating operative time and intraoperative blood loss. In addition, laboratory parameters will be assessed on postoperative days 1 and 5 to compare the degree of muscle injury (creatine kinase [CK], lactate dehydrogenase [LDH]), inflammatory response (erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]), and blood loss (hemoglobin [Hb], hematocrit [Hct]).;Comparison of postoperative recovery rates among the three surgical techniques will be conducted by evaluating length of hospital stay, time to ambulation, opioid analgesic consumption, and Visual Analogue Scale (VAS) pain scores measured on postoperative days 1, 3, and 5.;The degree of neural decompression will be compared using MRI obtained preoperatively and within 5 days postoperatively. The cross-sectional area of the dural sac will be measured on axial images at the disc level of the operated segment and analyzed comparatively among the surgical techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anterior and posterior intervertebral disc heights at the fused segment will be compared using standing radiographs obtained preoperatively and at postoperative day 5, and at 4, 12, 24, 48, and 96 weeks.;Segmental lordosis at the fused level (defined by the superior and inferior endplates of the involved vertebral bodies) and overall lumbar lordosis will be compared using standing radiographs obtained preoperatively and at postoperative day 5, and at 4, 12, 24, 48, and 96 weeks.;Fusion rate and cage subsidence rate will be compared using computed tomography (CT) scans obtained at 48 and 96 weeks postoperatively.;The cross-sectional areas of the bilateral psoas muscles and lumbar multifidus muscles at the operated disc level on axial CT images will be compared between the preoperative baseline and postoperative time points at 48 and 96 weeks.;The incidence of various complications will be evaluated immediately postoperatively and at 4, 12, 24, 48, and 96 weeks after surgery.;The improvement rate in Visual Analogue Scale (VAS), ODI(Oswestry Disability Index), SF-36(Short Form 36-item) scores will be assessed at 4, 12, 24, 48, and 96 weeks postoperatively, compared with the preoperative baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactDongkyu Kim
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed