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

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.

NCT Number	NCT07040293
Lead Sponsor	Shanghai Changzheng Hospital Collaborators: Fujian Medical University Union Hospital, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, Beijing Chao Yang Hospital, First Affiliated Hospital of Guangxi Medical University, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan TongJi Hospital
Conditions	Lumbar Fusion Surgery, Fusion of Joint
Enrollment	330 participants
Start Date	2025-07-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-27