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Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation for LSS Combined With Lumbar Instability

Primary Purpose

Lumbar Spinal Stenosis, Lumbar Instability

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CLIF-LP
TLIF
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring lumbar spinal stenosis;lumbar instability

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Patients with evidence of neurological disorders (such as peripheral neuropathy), neuromuscular disorders (such as multiple sclerosis, Parkinson's disease, etc.), or systemic diseases (such as inflammatory arthritis) that affect bodily function The patient has participated in other clinical trials in the past 3 months Patients with poor adherence, judged by the researchers to be unable to complete the trial according to the study plan, such as schizophrenia and dementia, did not provide consent to volunteer to participate in the clinical study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Patients who received CLIF-LP treatment

    Patients who received TLIF treatment

    Outcomes

    Primary Outcome Measures

    Oswestry Disability index (ODI)
    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.

    Secondary Outcome Measures

    Visual analogue scale(VAS)
    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.
    Japanese Orthopaedic Association (JOA)
    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.
    EuroQoL-5D-5L
    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.

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06058143
    Brief Title
    Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation for LSS Combined With Lumbar Instability
    Official Title
    Efficacy of Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation Versus Transforaminal Lumber Interbody Fusion for Lumbar Spinal Stenosis Combined With Lumbar Instability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2026 (Anticipated)
    Study Completion Date
    November 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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).
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Spinal Stenosis, Lumbar Instability
    Keywords
    lumbar spinal stenosis;lumbar instability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Patients who received CLIF-LP treatment
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Patients who received TLIF treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    CLIF-LP
    Intervention Description
    CLIF-LP surgery method was applied
    Intervention Type
    Procedure
    Intervention Name(s)
    TLIF
    Intervention Description
    TLIF surgery method was applied
    Primary Outcome Measure Information:
    Title
    Oswestry Disability index (ODI)
    Description
    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
    24 months after surgery
    Secondary Outcome Measure Information:
    Title
    Visual analogue scale(VAS)
    Description
    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
    Title
    Japanese Orthopaedic Association (JOA)
    Description
    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
    Title
    EuroQoL-5D-5L
    Description
    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.
    Time Frame
    1 month, 3 months, 6 months, 12 months and 24 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 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 Patients with evidence of neurological disorders (such as peripheral neuropathy), neuromuscular disorders (such as multiple sclerosis, Parkinson's disease, etc.), or systemic diseases (such as inflammatory arthritis) that affect bodily function The patient has participated in other clinical trials in the past 3 months Patients with poor adherence, judged by the researchers to be unable to complete the trial according to the study plan, such as schizophrenia and dementia, did not provide consent to volunteer to participate in the clinical study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhan Wang, PhD
    Phone
    -8618758586092
    Email
    wangzhanhz@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ning Zhang, PhD
    Organizational Affiliation
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation for LSS Combined With Lumbar Instability

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