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NCT07040293
Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery
NA trial testing Absorbable bone wax for hemostasis in the osteotomy surface of the facet joint in Lumbar Fusion Surgery in 330 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Shanghai Changzheng Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 330 |
| Start date | 1 July 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 30 June 2028 |
| Sites | 1 location across China |
Drugs / interventions 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
Conditions studied
- Lumbar Fusion Surgery — all drugs for Lumbar Fusion Surgery →
- Fusion of Joint — all drugs for Fusion of Joint →
Sponsor
Shanghai Changzheng Hospital
Who can join
Adults 18 to 75, any sex, with Lumbar Fusion Surgery or Fusion of Joint. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07040293
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Lumbar Fusion Surgery
Currently open trials in the same condition.
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Other Shanghai Changzheng Hospital trials
Trials by the same sponsor.
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- NCT07398326 — Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer · Phase 2 · recruiting
- NCT07381257 — Efficacy and Safety of Rifaximin-α in Treating MASLD · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07040293 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Changzheng Hospital
- Last refreshed: 27 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07040293.
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