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

N/ANot Yet RecruitingNCT07040293

Shanghai Changzheng Hospital330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

Lumbar Fusion Surgery

Interventions

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

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.

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Individuals deemed by researchers to have poor compliance, rendering them unable to fulfill the study requirements. * Women who are currently pregnant, intend to become pregnant within the past year, or are breastfeeding. * Individuals who have participated in other clinical trials within the preceding 30 days to prevent cross-interference. * Individuals with significant complications or comorbidities, such as severe cardiovascular, hepatic, renal, or other chronic conditions that could influence surgical risks and research outcomes. * Individuals identified by researchers as having a life expectancy of less than six months. * Individuals with severe osteoporosis, defined as a bone mineral density T-score of ≤-2.5 accompanied by fragility fractures. * Any other individuals deemed unsuitable for participation in this clinical trial by the researchers.

Outcomes

Primary Outcomes

The clinical fusion rate of lumbar facet joints

The proportion of individuals achieving the clinical fusion standard of the facet joint was assessed within each group. Six months postoperatively, the fusion status of the facet joints at the surgical segments was evaluated using continuous thin-slice CT plain scans combined with three-dimensional reconstruction images of the lumbar vertebrae. The evaluation criteria were based on the guidelines established by Ren et al. (2020) in their study on modified facet joint fusion for lumbar degenerative disease. According to these criteria, clinical fusion is confirmed when one side of the facet joint attains grade I or grade II radiological fusion standards.

Time frame: 6 months

Secondary Outcomes

The success rate of hemostasis within three minutes

The success rate of achieving hemostasis within three minutes during surgery is defined as the proportion of patients who meet the hemostatic objective within this timeframe.

Time frame: 3 minutes

Postoperative wound healing

Postoperative wound healing is assessed 14 days following the procedure, with observations including the presence of bleeding, redness, and swelling at the wound site.

Time frame: 14 days