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

Not Applicable

• Conditions: Spinal Deformity; Minimally Invasive; Degenerative Scoliosis
• Interventions: Procedure: Modified lateral lumbar interbody fusion

• Registration Number: NCT04071665
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Study Start: 2020-05-01
• Last Update Submitted: 2020-05-10
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-01-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified lateral lumbar interbody fusion	Modified lateral lumbar interbody fusion	Modified lateral lumbar interbody fusion for treatment of scoliosis
transforaminal lumbar interbody fusion	Modified lateral lumbar interbody fusion	transforaminal lumbar interbody fusion

Primary Outcome Measures

Name	Time	Method
ODI score	2 years	an index for assessing the lower back pain wiith multiple questionnare

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zejiang University; 🇨🇳 Hangzhou, Zhejiang, China