Lumbar Fusion SurgeryNCT07040293
Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery
A study testing Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint and Traditional bone wax for hemostasis in the osteotomy surface of the facet joint in people with Lumbar Fusion Surgery and Fusion of Joint, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Fusion Surgery, Fusion of Joint
- What is being tested?
- Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint and Traditional bone wax for hemostasis in the osteotomy surface of the facet joint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
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
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
- Being tested
- Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint, Traditional bone wax for hemostasis in the osteotomy surface of the facet joint
- Keywords
- absorbable bone wax, traditional bone wax, facet fusion after lumbar fusion surgery, hemostasis
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Absorbable bone wax gruop | Experimental | Not described Receives: Device: Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint |
| Traditional bone wax group | Active comparator | Not described Receives: Device: Traditional bone wax for hemostasis in the osteotomy surface of the facet joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Lumbar Fusion SurgeryStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, Beijing Chao Yang Hospital, First Affiliated Hospital of Guangxi Medical University, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan TongJi Hospital
- Responsible party
- Principal investigator, Haifeng Wei, MD, PhD, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040293
- Sponsor's protocol ID
- 2024SL158
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 32469075Vestergaard 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.
PubMed 24119983An 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.
PubMed 26949464Kim 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.
PubMed 37763664Wang 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.
PubMed 39113538Duan 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.
PubMed 36741749Choi 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.
PubMed 34387533Tham 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.
PubMed 30271614Wellisz 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.
PubMed 18196435Gibbs 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.
PubMed 15108734Schonauer 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.
PubMed 15221572Julsrud ME. A surgical complication: allergic reaction to bone wax. J Foot Surg. 1980 Fall;19(3):152-4. No abstract available.
PubMed 7021652Solomon 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.
PubMed 22760602Crocker 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.
PubMed 19085366Stein 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.
PubMed 19910449
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07040293
- Acronym / sponsor ID
- 2024SL158
- Conditions
- Lumbar Fusion Surgery, Fusion of Joint
- Keywords
- absorbable bone wax, traditional bone wax, facet fusion after lumbar fusion surgery, hemostasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Nanchang University, Qilu Hospital of Shandong University, Beijing Chao Yang Hospital, First Affiliated Hospital of Guangxi Medical University, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan TongJi Hospital
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable bone wax for hemostasis in the osteotomy surface of the facet jointFollowing 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 | Absorbable bone wax gruop |
| Traditional bone wax for hemostasis in the osteotomy surface of the facet jointFollowing 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. | Device | Traditional bone wax group |
Primary outcome
The clinical fusion rate of lumbar facet joints
Time frame: 6 months
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.
2 secondary outcomes
The success rate of hemostasis within three minutes
Time frame: 3 minutes
Postoperative wound healing
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Results publication: PubMed 32469075Ren 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.
- Results publication: PubMed 24119983Vestergaard 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.
- Results publication: PubMed 26949464An 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.
- Results publication: PubMed 37763664Kim 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.
- Results publication: PubMed 39113538Wang 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.
- Results publication: PubMed 36741749Duan 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.
- Results publication: PubMed 34387533Choi 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.
- Results publication: PubMed 30271614Tham 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.
- Results publication: PubMed 18196435Wellisz 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.
- Results publication: PubMed 15108734Gibbs 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.
- Results publication: PubMed 15221572Schonauer 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.
- Results publication: PubMed 7021652Julsrud ME. A surgical complication: allergic reaction to bone wax. J Foot Surg. 1980 Fall;19(3):152-4. No abstract available.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint and Traditional bone wax for hemostasis in the osteotomy surface of the facet joint in people with Lumbar Fusion Surgery and Fusion of Joint, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongjie Jiang (+86-159-0073-1700, jdjspine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical fusion rate of lumbar facet joints (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040293, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.