Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344890
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2006-06-23
Brief Title:
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
Sponsor:
LifeNet Health
Organization:
LifeNet Health
Study Overview
Official Title:
A Safety and Efficacy Comparison of Preservon Treated Allograft Bone Dowels Versus Traditional Freeze-Dried Allograft Bone Dowels for Fusion of Degenerated Cervical Intervertebral Discs in the Treatment of Cervical Radiculopathy or Myelopathy
Status:
COMPLETED
Status Verified Date:
2015-04
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:
The purpose of this study is to compare the safety and efficacy of PreservonTM treated allograft bone dowels to traditional freeze-dried allograft bone dowels control for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy
Patient follow-up will be conducted at 6 weeks 3 months and 6 months At 3 months after surgery the implanted bone dowels will be assessed for subsidence at 6 months after surgery the implanted bone dowels will be assessed for fusion Patients will complete questionnaires and x-rays taken at each visit
The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received
Patient follow-up will be conducted at 6 weeks 3 months and 6 months At 3 months after surgery the implanted bone dowels will be assessed for subsidence at 6 months after surgery the implanted bone dowels will be assessed for fusion Patients will complete questionnaires and x-rays taken at each visit
The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB Protocol 20061453 | None | None | None |