NCT03360409

Brief Summary

Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

November 26, 2017

Last Update Submit

November 30, 2017

Conditions

Cervical Disc Degeneration

Keywords

Cervical Disc Degenerationcervical anterior discectomySpinal alignment

Outcome Measures

Primary Outcomes (1)

  • change of cervical alignment

    The Harrison posterior tangent method was used as an estimate for curvature

    1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years

Secondary Outcomes (1)

  • quality of life

    1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years

Study Arms (3)

grade 1

EXPERIMENTAL

ACD

Procedure: ACD

grade 2

ACTIVE COMPARATOR

ACDF

Procedure: ACDF

grade 3

ACTIVE COMPARATOR

ACDA

Procedure: ACDA

Interventions

ACDPROCEDURE

Undertake anterior cervical discectomy without fusion

grade 1
ACDFPROCEDURE

anterior cervical discectomy with fusion

grade 2
ACDAPROCEDURE

anterior cervical discectomy with arthroplasty

grade 3

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with arm pain not responding to conservative treatment
  • lasted longer than 10 weeks
  • single level disc degeneration
  • mobile spine on dynamic lateral cervical X-rays

You may not qualify if:

  • severe cardiopulmonary comorbidity
  • suspected underlying malignant disease
  • radicular syndrome
  • spinal-cord compression syndrome
  • contraindication for radiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • zhenqi zhu

    PekingUPH department of spinal surgery

    STUDY DIRECTOR

Central Study Contacts

chen guo

CONTACT

8618055644700fantasy_g@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of spinal surgery

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 4, 2017

Study Start

February 1, 2018

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

December 4, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share