Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 7:54 PM
Study NCT ID:
NCT07040293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery
Sponsor:
Shanghai Changzheng Hospital
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Absorbable Bone Wax and Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery: A Multicenter, Randomized, Open-label, Superiority Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
Hemorrhage on the surface of cancellous bone presents a significant challenge in orthopedic surgery. Traditional bone wax, commonly utilized for hemostasis in bone wounds, is non-absorbable and associated with various complications, including pseudarthrosis, paralysis, venous sinus thrombosis, chronic inflammation, allergic reactions, and infections, thereby limiting its clinical utility. In contrast, absorbable bone wax, primarily composed of medical-grade water-soluble polymer materials, exhibits excellent biocompatibility. It is fully absorbed, excreted, or eliminated by the body without leaving toxic residues. This study employs a rigorous efficacy design to select an appropriate patient cohort for lumbar fusion surgery, based on specific inclusion and exclusion criteria. Participants are randomly assigned to either an experimental group receiving absorbable bone wax or a control group receiving traditional bone wax, facilitating a randomized, open-label, parallel-controlled clinical trial. This study aims to evaluate the comparative effects of absorbable bone wax versus traditional bone wax on the rate of bone fusion following hemostasis of bone wounds. The objective is to furnish robust evidence-based insights into the application of absorbable bone wax for bone wounds necessitating fusion, thereby establishing a safe, effective, and broadly applicable technique for bone wound hemostasis in clinical practice.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: