NCT04071665

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 12, 2020

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

August 26, 2019

Last Update Submit

May 10, 2020

Conditions

Degenerative ScoliosisMinimally InvasiveSpinal Deformity

Outcome Measures

Primary Outcomes (1)

  • ODI score

    an index for assessing the lower back pain wiith multiple questionnare

    2 years

Study Arms (2)

Modified lateral lumbar interbody fusion

EXPERIMENTAL

Modified lateral lumbar interbody fusion for treatment of scoliosis

Procedure: Modified lateral lumbar interbody fusion

transforaminal lumbar interbody fusion

ACTIVE COMPARATOR

transforaminal lumbar interbody fusion

Procedure: Modified lateral lumbar interbody fusion

Interventions

Modified lateral lumbar interbody fusionPROCEDURE

Modified lateral lumbar interbody fusion

Modified lateral lumbar interbody fusiontransforaminal lumbar interbody fusion

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • with prior lumbar fusion surgery or spondylolisthesis greater than Grade II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26537171BACKGROUND

  • 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.

    PMID: 28296697BACKGROUND

  • 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.

    PMID: 24488750BACKGROUND

  • 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.

    PMID: 27843677RESULT

  • 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.

    PMID: 27843676RESULT

Study Officials

  • Qixin CHEN, Ph.D

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

    STUDY DIRECTOR

Central Study Contacts

Fangcai LI, Ph.D

CONTACT

86-05718778459489048991@qq.com

Zhiwei WANG, Ph.D

CONTACT

86-057187784594wangzhiwei929@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

May 1, 2020

Primary Completion

January 1, 2021

Study Completion

December 31, 2022

Last Updated

May 12, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

after complete the recruiment with half of participants, we will share the preliminary results with data.

Locations

CN(1)