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New treatment option for Lumbar Spinal Stenosis
Official title Comparative Analysis of Two Transforaminal Lumbar Interbody Fusion (TLIF) Procedures in the Treatment of Single-Level Lumbar Spinal Stenosis (LSS): A Single-Center, Prospective, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07588555
What this study is testing
- What it's testing
- Lumbar spinal stenosis (LSS), a common degenerative lumbar condition characterized by low back pain, leg pain, and neurogenic claudication, significantly impairs patients' quality of life. Its prevalence continues to rise with the aging population.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- Age ranging from 40 to 70 years, irrespective of sex.
- Presence of bilateral lower-limb pain and neurogenic claudication, with or without low back pain.
- Preoperative computed tomography or magnetic resonance imaging confirming single-level lumbar spinal stenosis accompanied by grade II or higher...
- Persistent pain within 7 days prior to enrollment, with inadequate response to nonsurgical treatment for more than 3 months.
- Willingness to provide written informed consent and ability to comply with the study protocol and visit schedule.
You likely can't join if
- Patients with evidence of vascular claudication identified by lower-limb color Doppler ultrasound.
- Patients with a history of previous lumbar spine surgery.
- Coexistence of severe lumbar disc herniation, spinal deformity, spinal tumor, infection, or inflammatory diseases.
- Pregnancy or lactation.
- Presence of severe underlying medical conditions or psychiatric disorders that preclude tolerance of the procedure.
- Known concurrent diseases considered by the investigator to preclude study entry.
See the full eligibility criteria
- Age ranging from 40 to 70 years, irrespective of sex.
- Presence of bilateral lower-limb pain and neurogenic claudication, with or without low back pain.
- Preoperative computed tomography or magnetic resonance imaging confirming single-level lumbar spinal stenosis accompanied by grade II or higher lumbar spondylolisthesis and/or lumbar instability.
- Persistent pain within 7 days prior to enrollment, with inadequate response to nonsurgical treatment for more than 3 months.
- Willingness to provide written informed consent and ability to comply with the study protocol and visit schedule.
- Patients with evidence of vascular claudication identified by lower-limb color Doppler ultrasound.
- Patients with a history of previous lumbar spine surgery.
- Coexistence of severe lumbar disc herniation, spinal deformity, spinal tumor, infection, or inflammatory diseases.
- Pregnancy or lactation.
- Presence of severe underlying medical conditions or psychiatric disorders that preclude tolerance of the procedure.
- Known concurrent diseases considered by the investigator to preclude study entry.
- Inability to comply with study assessments or complete questionnaires for any reason.
- Patients deemed unsuitable for participation in this trial as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.