Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06155409
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-11-23
Brief Title:
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease
Sponsor:
SPINEVISION SAS
Organization:
SPINEVISION SAS
Study Overview
Official Title:
Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease disease that occurs when the spinal disk breaks down at the cervical spine level C3-C7
Part of their standard of care participants will be questioned on their neck and arm pains their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery Those data will be collected up to twenty four 24 months after the Hexanium ACIF system implant surgery
Part of their standard of care participants will be questioned on their neck and arm pains their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery Those data will be collected up to twenty four 24 months after the Hexanium ACIF system implant surgery
Detailed Description:
The Hexanium ACIF study is a multicentric non-randomized ambispective post market clinical follow-up study This means that either subjects already implanted with the Hexanium ACIF system retrospective subjects or subjects planned for treatment with the Hexanium ACIF system prospective subjects can be enrolled in hte study
Standard of care subjects data up to twenty four 24 months post Hexanium ACIF system implant procedure will be collected key data include neck and arm Visual Analogue Score VAS Neck Disability Index NDI score and adverse events
Data will be collected at Month 2 Month 6 Month 12 and Month 24 post surgery
Standard of care subjects data up to twenty four 24 months post Hexanium ACIF system implant procedure will be collected key data include neck and arm Visual Analogue Score VAS Neck Disability Index NDI score and adverse events
Data will be collected at Month 2 Month 6 Month 12 and Month 24 post surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None