Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-28 @ 12:33 PM
Study NCT ID:
NCT03959059
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2019-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PKP Assisted With MR Technology in OVCF With IVC
Sponsor:
Nanjing First Hospital, Nanjing Medical University
Organization:
Study Overview
Official Title:
Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
Status:
COMPLETED
Status Verified Date:
2019-05
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:
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.
Detailed Description:
The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.
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?:
None
Is an FDA AA801 Violation?: