Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491030
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-20
Brief Title:
Post-Operative Thoracolumosacral Orthosis for PJK
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Proximal junctional kyphosis PJK is a common post-operative radiographic finding after surgery for adult spinal deformity ASD patients Although the clinical relevance of isolated PJK is unclear PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery Currently post-operative bracing with a thoracolumbosacral orthosis TLSO is common practice after spinal deformity surgery however the efficacy of this in preventing PJK is unknown This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None