A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis

Study Overview
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Brief Summary
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A modified lateral lumbar interbody fusion VS. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study

Detailed Description
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Adult degenerative scoliosis (ADS) is the most common spinal deformity in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new choice for spinal surgeons to treat ADS. Modified lateral lumbar interbody fusion (CLIF) is an new modified spinal minimally invasive interbody fusion technique in the investigator's department. The results of preliminary studies showed that it has the advantages of less trauma, short operation time and fewer complications, and the clinical and imaging outcome are remarkable. Therefore, the present study aims to establish a multicenter, large sample prospective randomized controlled study to explore the technical advantages and surgical indications of the new technique in the treatment of ADS by comparing with the traditional posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish a long-term follow-up to further quantify the clinical and imaging outcome of the new technique. Therefore, this study will further verify the safety and effectiveness of the CLIF in the treatment of ADS on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of ADS.

Official Title
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A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis

Conditions
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Degenerative Scoliosis, Minimally Invasive, Spinal Deformity

Intervention / Treatment
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* Procedure: Modified lateral lumbar interbody fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 50 years of age, diagnosed with adult thoracolumbar scoliosis including any number of intervertebral levels between T8 and S1, unresponsive to conservative treatment for at least 6 months, and had a preoperative coronal Cobb angle of at least 10° and preoperative ODI score of at least 30%. Exclusion Criteria: with prior lumbar fusion surgery or spondylolisthesis greater than Grade II

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified lateral lumbar interbody fusion<br>Modified lateral lumbar interbody fusion for treatment of scoliosis | Procedure: Modified lateral lumbar interbody fusion<br>* Modified lateral lumbar interbody fusion<br>|
| Active Comparator: transforaminal lumbar interbody fusion<br>transforaminal lumbar interbody fusion | Procedure: Modified lateral lumbar interbody fusion<br>* Modified lateral lumbar interbody fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI score | an index for assessing the lower back pain wiith multiple questionnare | 2 years |