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Clinical study on the safety and effectiveness of absorbable bone wax in oblique lateral lumbar interbody fusion

Clinical study on the safety and effectiveness of absorbable bone wax in oblique lateral lumbar interbody fusion

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113396
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar instability, discogenic low back pain, lumbar spondylolisthesis, lumbar spinal stenosis, etc.

Interventions

Control group:Use non-absorbable bone wax
Experimental group:Use absorbable bone wax

Sponsors

Shanghai Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients are between 18 and 75 years old, regardless of sex. 2. Lumbar instability, discogenic low back pain, lumbar spondylolisthesis, lumbar spinal stenosis and other patients who plan to receive oblique lateral lumbar interbody fusion. 3. Subjects can understand the purpose of the experiment and voluntarily participate in and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with hemorrhagic diathesis or coagulation disorders (prothrombin time [PT] >=18 s); those on long-term anticoagulant therapy. 2. Patients with lumbar infection or fracture. 3. Patients allergic to polyethylene glycol, sodium carboxymethylcellulose, or bone wax (including beeswax, paraffin, and isopropyl palmitate). 4. The patient is in critical condition, and it is difficult to make an exact evaluation of the effectiveness and safety of the instrument. 5. The researcher judged that the patient's compliance was poor and the study could not be completed as required. 6. Pregnant or pregnant women in the past year, lactating women. 7. Patients with major complications or comorbidities, including severe cardiac, hepatic, or renal disease, or other chronic conditions that may affect surgical risk or study outcomes. 8. Patients with an investigator-estimated survival of less than six months. 9. Patients with severe osteoporosis (bone mineral density T-score <= -2.5 accompanied by fragility fractures).

Design outcomes

Primary

MeasureTime frame
Fusion rate at 6 months postoperatively;

Secondary

MeasureTime frame
Successful hemostasis rate;Assessment of wound drainage volume and presence of bloody exudate on the first postoperative day;

Countries

China

Contacts

Public ContactXiaojian Ye

Shanghai Tongren Hospital

yexj2002@163.com+86 21 52039999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026