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NCT07040293

Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery

Not yet recruiting NA Last updated 27 June 2025
What this trial tests

NA trial testing Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint in Lumbar Fusion Surgery in 330 participants. Not yet recruiting.

Timeline
1 July 2025
Primary endpoint
31 December 2027
30 June 2028

Quick facts

Lead sponsorShanghai Changzheng Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment330
Start date1 July 2025
Primary completion31 December 2027
Estimated completion30 June 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Changzheng Hospital

Who can join

Adults 18 to 75, any sex, with Lumbar Fusion Surgery or Fusion of Joint. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Lumbar Fusion Surgery

Currently open trials in the same condition.

Other Shanghai Changzheng Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07040293.

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