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

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.

Conditions

• Lumbar Fusion Surgery
• Fusion of Joint

Interventions

DEVICE

Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint

Following the enrollment of patients who underwent posterior lumbar decompression, intervertebral bone graft, and internal fixation surgery, a "V-shaped" osteotomy was executed at the facet joint contralateral to the decompression site, with 0.5g absorbable bone wax subsequently applied to the osteotomy surface.

DEVICE

Traditional bone wax for hemostasis in the osteotomy surface of the facet joint

Following the enrollment of patients who underwent posterior lumbar decompression, intervertebral bone graft fusion, and internal fixation surgery, a "V-shaped" osteotomy was executed at the facet joint contralateral to the decompression site, with 0.5g traditional bone wax subsequently applied to the osteotomy surface.

Sponsors & Collaborators

• Fujian Medical University Union Hospital

  collaborator OTHER

• Jiangxi Provincial People's Hopital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2027-12-31

Completion

2028-06-30

Countries

• China

Study Locations