NCT01011569

Brief Summary

There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. The object of the present study is to present design of prospective study and to demonstrate preliminary result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2004

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

9.5 years

First QC Date

November 10, 2009

Last Update Submit

April 13, 2018

Conditions

Cervical Disc Disease

Keywords

difference

Outcome Measures

Primary Outcomes (1)

  • Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level

    1/3/6/12/24/36 months after operation

Study Arms (2)

cage

patient who underwent stand alone cage insertion after discectomy

plate

patient who underwent plate fixation and autologous ilia bone graft after discectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient who needs surgery due to cervical disc disease

You may not qualify if:

  • We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • Kim CH, Chung CK, Hahn S. Autologous iliac bone graft with anterior plating is advantageous over the stand-alone cage for segmental lordosis in single-level cervical disc disease. Neurosurgery. 2013 Feb;72(2):257-65; discussion 266. doi: 10.1227/NEU.0b013e31827b94d4.

    PMID: 23149973RESULT

  • Lee SE, Chung CK, Kim CH. Difference in canal encroachment by the fusion mass between anterior cervical discectomy and fusion with bone autograft and anterior plating, and stand-alone cage. J Clin Neurosci. 2016 Jul;29:121-7. doi: 10.1016/j.jocn.2015.10.039. Epub 2016 May 24.

    PMID: 27234609DERIVED

Study Officials

  • Chun Kee Chung, professor

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

April 1, 2004

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

KR(1)