Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01011569
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2009-11-10
Brief Title:
Comparison of Cage Versus Plate in One Level Cervical Disc Disease
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are largely 2 surgical methods for one-level cervical disc disease cage only and plategraft Even there are many reports about the efficacy of either cage only or plategraft prospective comparative study is few The object of the present study is to present design of prospective study and to demonstrate preliminary result
Detailed Description:
Prospective study was started from April 2004 after permission by our Institutional Review Board Inclusion criteria were single cervical disc disease with radiculopathymyelopathy 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 136122436 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 136122436 months after operation The present prospective study was planned until 80 patients cage n 40 plategraft n 40 were enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None