A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
Primary Purpose
Degenerative Scoliosis, Minimally Invasive, Spinal Deformity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified lateral lumbar interbody fusion
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Scoliosis
Eligibility Criteria
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
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified lateral lumbar interbody fusion
transforaminal lumbar interbody fusion
Arm Description
Modified lateral lumbar interbody fusion for treatment of scoliosis
transforaminal lumbar interbody fusion
Outcomes
Primary Outcome Measures
ODI score
an index for assessing the lower back pain wiith multiple questionnare
Secondary Outcome Measures
Full Information
NCT ID
NCT04071665
First Posted
August 26, 2019
Last Updated
May 10, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Shantou University Medical College, Shenzhen University
1. Study Identification
Unique Protocol Identification Number
NCT04071665
Brief Title
A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
Official Title
A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Shantou University Medical College, Shenzhen 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Scoliosis, Minimally Invasive, Spinal Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified lateral lumbar interbody fusion
Arm Type
Experimental
Arm Description
Modified lateral lumbar interbody fusion for treatment of scoliosis
Arm Title
transforaminal lumbar interbody fusion
Arm Type
Active Comparator
Arm Description
transforaminal lumbar interbody fusion
Intervention Type
Procedure
Intervention Name(s)
Modified lateral lumbar interbody fusion
Intervention Description
Modified lateral lumbar interbody fusion
Primary Outcome Measure Information:
Title
ODI score
Description
an index for assessing the lower back pain wiith multiple questionnare
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangcai LI, Ph.D
Phone
86-057187784594
Email
89048991@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiwei WANG, Ph.D
Phone
86-057187784594
Email
wangzhiwei929@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qixin CHEN, Ph.D
Organizational Affiliation
Orthopedics Department, 2nd Hospital, School of Medicine, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwei Wang, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
after complete the recruiment with half of participants, we will share the preliminary results with data.
Citations:
PubMed Identifier
26537171
Citation
Mendoza-Lattes S. Cervical Disc Replacement: Are We There Yet? Commentary on an article by Michael E. Janssen, DO, et al.: "ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease. Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study". J Bone Joint Surg Am. 2015 Nov 4;97(21):e71. doi: 10.2106/JBJS.O.00750. No abstract available.
Results Reference
background
PubMed Identifier
28296697
Citation
Kretzer RM. Adult Degenerative Spinal Deformity: Overview and Open Approaches for Treatment. Spine (Phila Pa 1976). 2017 Apr 1;42 Suppl 7:S16. doi: 10.1097/BRS.0000000000002028. No abstract available.
Results Reference
background
PubMed Identifier
24488750
Citation
Bach K, Ahmadian A, Deukmedjian A, Uribe JS. Minimally invasive surgical techniques in adult degenerative spinal deformity: a systematic review. Clin Orthop Relat Res. 2014 Jun;472(6):1749-61. doi: 10.1007/s11999-013-3441-5.
Results Reference
background
PubMed Identifier
27843677
Citation
Epstein NE. Commentary on: Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis by Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. NEJM 2016;374 (15):1424-34. Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S644-S647. doi: 10.4103/2152-7806.191061. eCollection 2016.
Results Reference
result
PubMed Identifier
27843676
Citation
Epstein NE. Commentary on: A randomized controlled trial of fusion surgery for lumbar spinal stenosis (Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, et al. N Eng J Med 2016;374:1414-23). Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S641-S643. doi: 10.4103/2152-7806.191060. eCollection 2016.
Results Reference
result
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A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
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