Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery
NCT ID: NCT07040293
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
330 participants
INTERVENTIONAL
2025-07-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Absorbable bone wax gruop
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.
Traditional bone wax group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Jiangxi Provincial People's Hopital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Qilu Hospital of Shandong University
OTHER
Beijing Chao Yang Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Wuhan TongJi Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Responsible Party
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Haifeng Wei, MD, PhD
vice director
Locations
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Wellisz T, An YH, Wen X, Kang Q, Hill CM, Armstrong JK. Infection rates and healing using bone wax and a soluble polymer material. Clin Orthop Relat Res. 2008 Feb;466(2):481-6. doi: 10.1007/s11999-007-0067-5. Epub 2008 Jan 10.
Gibbs L, Kakis A, Weinstein P, Conte JE Jr. Bone wax as a risk factor for surgical-site infection following neurospinal surgery. Infect Control Hosp Epidemiol. 2004 Apr;25(4):346-8. doi: 10.1086/502403.
Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
Julsrud ME. A surgical complication: allergic reaction to bone wax. J Foot Surg. 1980 Fall;19(3):152-4. No abstract available.
Solomon LB, Guevara C, Buchler L, Howie DW, Byard RW, Beck M. Does bone wax induce a chronic inflammatory articular reaction? Clin Orthop Relat Res. 2012 Nov;470(11):3207-12. doi: 10.1007/s11999-012-2457-6. Epub 2012 Jul 4.
Crocker M, Nesbitt A, Rich P, Bell B. Symptomatic venous sinus thrombosis following bone wax application to emissary veins. Br J Neurosurg. 2008 Dec;22(6):798-800. doi: 10.1080/02688690802256399.
Stein JM, Eskey CJ, Mamourian AC. Mass effect in the thoracic spine from remnant bone wax: an MR imaging pitfall. AJNR Am J Neuroradiol. 2010 May;31(5):844-6. doi: 10.3174/ajnr.A1830. Epub 2009 Nov 12.
Kumar A, Kale SS, Dutta R, Kumar A. Post-thoracotomy paraplegia due to epidural migration of bone wax. Eur J Cardiothorac Surg. 2009 Apr;35(4):734-6. doi: 10.1016/j.ejcts.2008.11.037. Epub 2009 Feb 23.
Angelini GD, el-Ghamari FA, Butchart EG. Poststernotomy pseudo-arthrosis due to foreign body reaction to bone wax. Eur J Cardiothorac Surg. 1987;1(2):129-30. doi: 10.1016/1010-7940(87)90025-x.
Other Identifiers
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2024SL158
Identifier Type: -
Identifier Source: org_study_id
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