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

NCT ID: NCT04071665

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-12-31

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.

Conditions

Degenerative Scoliosis; Minimally Invasive; Spinal Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Modified lateral lumbar interbody fusion

Modified lateral lumbar interbody fusion for treatment of scoliosis

Group Type: EXPERIMENTAL

Modified lateral lumbar interbody fusion

Intervention Type: PROCEDURE

Modified lateral lumbar interbody fusion

transforaminal lumbar interbody fusion

transforaminal lumbar interbody fusion

Group Type: ACTIVE_COMPARATOR

Modified lateral lumbar interbody fusion

Intervention Type: PROCEDURE

Modified lateral lumbar interbody fusion

Interventions

Modified lateral lumbar interbody fusion

Modified lateral lumbar interbody fusion

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role: collaborator

Shenzhen University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qixin CHEN, Ph.D

Role: STUDY_DIRECTOR

Orthopedics Department, 2nd Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fangcai LI, Ph.D

Role: CONTACT

89048991@qq.com

86-057187784594

Zhiwei WANG, Ph.D

Role: CONTACT

wangzhiwei929@163.com

86-057187784594

Facility Contacts

Zhiwei Wang, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 26537171 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28296697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24488750 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27843677 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27843676 (View on PubMed)

Other Identifiers

NSFC 81702220

Identifier Type: -

Identifier Source: org_study_id