- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01011569
Comparison of Cage Versus Plate in One Level Cervical Disc Disease
April 13, 2018 updated by: Chun Kee Chung, Seoul National University Hospital
Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Prospective study was started from April 2004 after permission by our Institutional Review Board.
Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy.
We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.
Operation method was randomized using the table of random sampling numbers.
All operations were performed with standard anterior-medial approach.
Two types of cages and 2 types of plates were used: cage, MC+ cage (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA).
We checked neck disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and 1/3/6/12/24/36 months after operation.
Disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from X-rays and follow-up X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation.
The present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patient who needs surgery due to cervical disc disease
Description
Inclusion Criteria:
- Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy.
Exclusion Criteria:
- We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
cage
patient who underwent stand alone cage insertion after discectomy
|
plate
patient who underwent plate fixation and autologous ilia bone graft after discectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level
Time Frame: 1/3/6/12/24/36 months after operation
|
1/3/6/12/24/36 months after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Actual)
April 17, 2018
Last Update Submitted That Met QC Criteria
April 13, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAP trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Disc Disease
-
Assiut UniversityUnknownCervical Disc Disease | Cervical Disc Herniation | Cervical Disc Degeneration
-
Research SourceEnrolling by invitationCervical Disc DiseaseUnited States
-
Ataturk UniversityCompleted
-
NYU Langone HealthCompleted
-
Synthes USA HQ, Inc.CompletedSymptomatic Cervical Disc Disease
-
Providence Medical Technology, Inc.WithdrawnCervical Radiculopathy | Cervical Spondylosis | Cervical Degenerative Disc DiseaseUnited States
-
NuVasiveEnrolling by invitationDegenerative Disc Disease | Cervical Disc DiseaseUnited States
-
Xijing HospitalUnknownSymptomatic Cervical Disc Disease
-
Medtronic Spinal and BiologicsCompletedDegenerative Cervical Disc DiseaseSaudi Arabia, Greece, Serbia, Hungary, Czech Republic, Kuwait, Poland, Slovakia
-
LDR Spine USACompletedCervical Disc Disease | Cervical Disc DegenerationUnited States