Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550923
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2020-09-02
Brief Title:
Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults - A Randomized Prospective Multicenter Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Rigid interbody fusion device in bulk configuration has been widely used in anterior cervical discectomy and fusion ACDF surgery It is a randomized prospective multicenter clinical study to compare rigid and non-rigid fusion device in ACDF for cervical degenerative disc disease
Detailed Description:
This study is a randomized prospective multicenter clinical trial comparing rigid PEEK interbody fusion device with non-rigid Titanium Alloy Z-Brace Baui Biotech interbody fusion device in ACDF surgery at 11 clinical sites ACDF was performed with stand-alone interbody fusion device and artificial bone graft hydroxyapatitetricalcium phosphate Patients have 1-level or 2-level cervical degenerative disc disease approved for ACDF surgery by National Health Insurance which is the blind third-party administrative approved and insurance reimbursement for surgical indication Total 180 patients were enrolled and 180 patients were randomized into either investigational device non-rigid group or the control rigid group in a 21 ratio After confirming a patients eligibility and having the patient sign an informed consent form the site investigator or study coordinator call the coordinator at National Taiwan University Hospital for the randomization Each patient will be then assigned to 1 of the treatment group according to a randomized schedule Patient were evaluated preoperatively one month postoperatively and 3 6 12 18 and 24 months postoperatively Measured outcomes included overall success Neck Disability Index NDI VAS neck and arm pain adjacent range of motion patient satisfaction anxiety score SF-12 MCSPCS major complications subsequent surgery rate and subsidence and fusion rate on radiological examinations The primary endpoint was a FDA composite definition of success comprising clinical improvement and absence of major complications and secondary surgery events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None