A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Modified lateral lumbar interbody fusion Modified lateral lumbar interbody fusion for treatment of scoliosis |
Procedure: Modified lateral lumbar interbody fusion
Modified lateral lumbar interbody fusion
|
| Active Comparator: transforaminal lumbar interbody fusion transforaminal lumbar interbody fusion |
Procedure: Modified lateral lumbar interbody fusion
Modified lateral lumbar interbody fusion
|
Outcome Measures
Primary Outcome Measures
- ODI score [2 years]
an index for assessing the lower back pain wiith multiple questionnare
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, School of Medicine, Zejiang University | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- First Affiliated Hospital of Shantou University Medical College
- Shenzhen University
Investigators
- Study Director: Qixin CHEN, Ph.D, Orthopedics Department, 2nd Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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.
- NSFC 81702220