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

NCT07040293 | Not Yet Recruiting

• 1 other identifier: 2024SL158
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

absorbable bone wax; traditional bone wax; facet fusion after lumbar fusion surgery; hemostasis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• The success rate of hemostasis within three minutes

  3 minutes

• Postoperative wound healing

  14 days

Other Outcomes (4)

• Incidence of adverse events

  6 months

• Postoperative infection rate

  6 months

• Reoperation rate

  6 months

Study Arms (2)

Absorbable bone wax gruop

EXPERIMENTAL

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

Traditional bone wax group

ACTIVE COMPARATOR

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

Interventions

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

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.

Absorbable bone wax gruop

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

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.

Traditional bone wax group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• 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

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Related Publications (17)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 18196435 BACKGROUND

• 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.

  PMID: 15108734 BACKGROUND

• 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.

  PMID: 15221572 BACKGROUND

• Julsrud ME. A surgical complication: allergic reaction to bone wax. J Foot Surg. 1980 Fall;19(3):152-4. No abstract available.

  PMID: 7021652 BACKGROUND

• 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.

  PMID: 22760602 BACKGROUND

• 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.

  PMID: 19085366 BACKGROUND

• 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.

  PMID: 19910449 BACKGROUND

• 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.

  PMID: 19233676 BACKGROUND

• 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.

  PMID: 2856608 BACKGROUND

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Dongjie Jiang

CONTACT

+86-159-0073-1700; jdjspine@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)