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

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071665
• Other study ID #: NSFC 81702220
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Fangcai LI, Ph.D
• Phone: 86-057187784594
• Email: 89048991[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Scoliosis
• Minimally Invasive
• Scoliosis
• Spinal Deformity

Intervention

Procedure:
• Modified lateral lumbar interbody fusion
Modified lateral lumbar interbody fusion

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zejiang University	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Shantou University Medical College, Shenzhen University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Epstein NE. Commentary on: A randomized controlled trial of fusion surgery for lumbar spinal stenosis (Forsth P, Ólafsson G, Carlsson T, Frost A, Borgström F, Fritzell P, et al. N Eng J Med 2016;374:1414-23). Surg Neurol Int. 2016 Sep 22;7(Suppl 25):S641- — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODI score	an index for assessing the lower back pain wiith multiple questionnare	2 years