Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532968
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain paralysis and other symptoms However the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma leading to postoperative back and lower limb pain Therefore this trial is divided into two groups comparing the use of the cross connector of the ORION spinal system - the spinal lamina cover and the general spinal fixation system without lamina cover For participants undergoing laminectomy with internal fixation and osseofusion after utilizing the spinal lamina cover of the ORION spinal system whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced and the pain in the back and lower limbs can be improved
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