Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation for LSS Combined With Lumbar… (NCT06058143) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation for LSS Combined With Lumbar Instability
98 participantsStarted 2023-11
Plain-language summary
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has many advantages and showed good results for patients with LSS and lumbar instability. Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 50-80 years old
. Patients diagnosed with clinical symptoms of lumbar spinal stenosis, neurogenic intermittent claudication, the patient's walking ability is highly limited, and the quality of life is severely reduced
. Imaging diagnosis of 1-2 LSS patients, consistent with clinical symptoms
. Lumbar spine instability can be considered if one of the following three criteria is met: ① mechanical back pain with severe (VAS \> 7) (pain aggravates with weight bearing). Radiographs of lumbar hyperextension and flexion show a slip of at least 3mm between the two vertebrae, or a rotation Angle of 11°. ③ Degenerative slip
. Formal conservative treatment is ineffective for more than 3 months
. No history of lumbar surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oswestry Disability index (ODI)
Timeframe: 24 months after surgery
Trial details
NCT IDNCT06058143
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. American College of Physicians ASA Grade I or II
. Subjects voluntarily sign informed consent as subjects
Exclusion criteria
. In patients with significant symptoms of lumbar radiculopathy, the pain from postural changes cannot be relieved
. Bone stenosis, including developmental lumbar spinal stenosis
. Free nucleus pulposus tissue into the spinal canal or cause spinal canal compression of the small joint cyst
. Patients with hypertrophy of the yellow ligament or small joint cyst as the main pressure
. Intervertebral space or posterior facet joints have fused
. Infectious, traumatic and neoplastic diseases of the lumbar spine
. Patients who are unable to undergo MRI
. Some medical conditions, such as metabolic bone disease, autoimmune disease, poliomyelitis sequelae, osteoporosis, history of poor bone healing, and long-term oral steroids, were determined by the investigators to be unsuitable for inclusion in the study