Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT05893160
Status:
WITHDRAWN
Last Update Posted:
2025-06-24
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Effects of Sustained-release Oral Sodium Nitrite Supplementation on Pain-related Outcomes and Peri- and Postoperative Physiology in People Undergoing Unilateral All-component Revision Total Knee Arthroplasty
Status:
WITHDRAWN
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdran per PI's request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.
Detailed Description:
The goal of this study is to examine the potential for oral sodium nitrite supplementation to reduce postoperative pain and inflammation and improve functional recovery in individuals undergoing unilateral revision total knee replacement. A sustained release formulation of sodium nitrite (40 mg) administered twice daily will be compared with placebo for a 30-day treatment period. Primary objectives are to evaluate pain and markers of functional improvement.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UAB | OTHER | Anesthesiology | View |