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

Official title

Evaluation of the Efficacy and Safety of Absorbable Bone Wax and Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery: A Multicenter, Randomized, Open-label, Superiority Clinical Trial

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.

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.

Primary outcome measures

• The clinical fusion rate of lumbar facet joints [Time frame: 6 months]

Secondary outcome measures (2)

• The success rate of hemostasis within three minutes [Time frame: 3 minutes]
• Postoperative wound healing [Time frame: 14 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Changzheng Hospital — Shanghai

Publications

• Ren Z, Li Z, Li S, Xu D, Chen X. Modified Facet Joint Fusion for Lumbar Degenerative Disease: Case Series of a Fusion Technique, Clinical Outcomes, and Fusion Rate in 491 Patients. Oper Neurosurg. 2020 Sep 1;19(3):255-263. doi: 10.1093/ons/opaa147. PMID 32469075
• Vestergaard RF, Nielsen PH, Terp KA, Soballe K, Andersen G, Hasenkam JM. Effect of hemostatic material on sternal healing after cardiac surgery. Ann Thorac Surg. 2014 Jan;97(1):153-60. doi: 10.1016/j.athoracsur.2013.08.030. Epub 2013 Oct 8. PMID 24119983
• An KC, Kong GM, Park DH, Baik JM, Youn JH, Lee WS. Comparison of Posterior Lumbar Interbody Fusion and Posterolateral Lumbar Fusion in Monosegmental Vacuum Phenomenon within an Intervertebral Disc. Asian Spine J. 2016 Feb;10(1):93-8. doi: 10.4184/asj.2016.10.1.93. Epub 2016 Feb 16. PMID 26949464
• Kim JG, Ham DW, Zheng H, Kwon O, Kim HJ. Evaluating the Efficacy of Water-Soluble Bone Wax (Tableau Wax) in Reducing Blood Loss in Spinal Fusion Surgery: A Randomized, Controlled, Pilot Study. Medicina (Kaunas). 2023 Aug 25;59(9):1545. doi: 10.3390/medicina59091545. PMID 37763664
• Wang R, Jin Z, Gao J, Ma Y, Han Q. Effectiveness and Biocompatibility Evaluation of a Novel Absorbable Bone Wax Used in Bone Tissue. Tissue Eng Part C Methods. 2024 Aug;30(8):353-363. doi: 10.1089/ten.TEC.2024.0144. PMID 39113538
• Duan Q, Liu H, Zheng L, Cai D, Huang G, Liu Y, Guo R. Novel resorbable bone wax containing beta-TCP and starch microspheres for accelerating bone hemostasis and promoting regeneration. Front Bioeng Biotechnol. 2023 Jan 19;11:1105306. doi: 10.3389/fbioe.2023.1105306. eCollection 2023. PMID 36741749
• Choi SY, Rhim J, Heo SA, Han WJ, Kim MH, Ha CW. Efficacy and safety of a novel hemostatic material, BoneStat, compared with Ostene and Bone Wax in a rat calvarial defect model. Int J Artif Organs. 2021 Oct;44(10):734-747. doi: 10.1177/03913988211021428. Epub 2021 Aug 13. PMID 34387533
• Tham T, Roberts K, Shanahan J, Burban J, Costantino P. Analysis of bone healing with a novel bone wax substitute compared with bone wax in a porcine bone defect model. Future Sci OA. 2018 Jul 26;4(8):FSO326. doi: 10.4155/fsoa-2018-0004. eCollection 2018 Sep. PMID 30271614

Identifiers

NCT: NCT07040293 · 2024SL158

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗