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

NCT06058143 | Not Yet Recruiting DMC

• 1 other identifier: Mars515
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Lumbar Spinal Stenosis; Lumbar Instability

Keywords

lumbar spinal stenosis;lumbar instability

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months after surgery

Secondary Outcomes (3)

• Visual analogue scale（VAS）

  1 month, 3 months, 6 months, 12 months and 24 months after surgery

• Japanese Orthopaedic Association (JOA)

  1 month, 3 months, 6 months, 12 months and 24 months after surgery

• EuroQoL-5D-5L

  1 month, 3 months, 6 months, 12 months and 24 months after surgery

Study Arms (2)

Group 1

EXPERIMENTAL

Patients who received CLIF-LP treatment

Procedure: CLIF-LP

Group 2

ACTIVE COMPARATOR

Patients who received TLIF treatment

Procedure: TLIF

Interventions

CLIF-LP PROCEDURE

CLIF-LP surgery method was applied

Group 1

TLIF PROCEDURE

TLIF surgery method was applied

Group 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ning Zhang, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Zhan Wang, PhD

CONTACT

-8618758586092; wangzhanhz@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share