CLIF-LP
ProcedureCLIF-LP surgery method was applied
NCT Number: NCT06058143
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).
Trial opening soon.
Get Notified50 year–80 year
All sexes
Interventional
Not applicable
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 the advantages of direct view operation, "safe" psoas major approach, application of modified retractor, and lateral plate reinforcement, which not only significantly improves the postoperative lumbar function and nerve function of patients with LSS and lumbar instability, but also significantly reduces related complications, accelerates rehabilitation, and reduces the medical cost of patients.
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CLIF-LP surgery method was applied
TLIF surgery method was applied
Time frame: 24 months after surgery
Lumbar function was assessed by the Oswestry Disability index (ODI) at 24 months after surgery. ODI includes 10 items, including waist and leg pain, personal life care, lifting heavy objects, walking, sitting, standing, sleeping, sexual life, social life, and whether you can travel freely. The total score is 50 points, and the lower the score, the better the function of the lumbar spine.
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Visual analogue scale (VAS) was used for pain scores, and mild pain was 0-3 points, which was tolerable; Moderate pain is 4 ~ 6 points, strong pain affects rest, but can be tolerated; Severe pain is a score of 7 to 10, and the patient's pain is intensified and unbearable.
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
The JOA lumbar spine score included four aspects: subjective symptoms, clinical signs, daily activities and bladder function. The highest JOA score was 29 and the lowest was 0. The lower the score was, the more severe the symptoms and the more obvious the dysfunction.
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
This scale is a multidimensional measure of health-related quality of life, and it is also the most widely used universal utility scale. EQ-5D-5L consists of five dimensions, namely mobility, self-care, daily activities, pain or discomfort, anxiety or depression, each area is rated on a five-point scale (i.e., no problem, mild problem, moderate problem, severe problem, extreme problem), with higher scores indicating worse conditions.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Efficacy of Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation Versus Transforaminal Lumber Interbody Fusion for Lumbar Spinal Stenosis Combined With Lumbar Instability
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