About this trial
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.
Eligibility criteria
Qualifiers
Participants must be aged between 18 and 75 years, with no restrictions on gender.
Participants with conditions such as single-segment lumbar intervertebral disc protrusion, lumbar spondylolisthesis, and lumbar spinal stenosis who are scheduled to undergo posterior decompression, intervertebral fusion, and internal fixation surgery.
Participants must be able to comprehend the objectives of the study, willingly participate, and provide informed consent by signing the consent form.
Disqualifiers
Individuals with a hemorrhagic predisposition or coagulation disorders, indicated by a prothrombin time (PT) of 18 seconds or greater, and those with a history of prolonged anticoagulant use.
Individuals presenting with lumbar spine infections or fractures.
Individuals with known allergies to materials such as polyethylene glycol, sodium carboxymethyl cellulose, and bone wax (including beeswax, paraffin, and isopropyl palmitate).
Individuals whose conditions are critical, making it challenging to accurately assess the efficacy and safety of the equipment.
Trial design
Treatments tested in this trial
- Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint
- Traditional bone wax for hemostasis in the osteotomy surface of the facet joint
Treatment groups
Sponsors and collaborators
Shanghai Changzheng Hospital
Lead sponsor
Fujian Medical University Union Hospital
Collaborator
Jiangxi Provincial People's Hopital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Chao Yang Hospital
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Wuhan TongJi Hospital
Collaborator