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Feasibility Analysis of Bone Cement-Gelatin Sponge Composite Intravertebral Prefilling Technique for Reducing Bone Cement Leakage in Stage I and II Kümmell’s Disease: A Prospective Randomized Controlled Trial

Feasibility Analysis of Bone Cement-Gelatin Sponge Composite Intravertebral Prefilling Technique for Reducing Bone Cement Leakage in Stage I and II Kümmell’s Disease: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070797
Enrollment
Unknown
Registered
2023-04-23
Start date
2019-11-15
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Osteoporotic vertebral compression fracture

Interventions

Experimental group:bone cement-gelatin sponge composite group
Control group:no bone cement-gelatin sponge composite group

Sponsors

The Second Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 88 Years

Inclusion criteria

Inclusion criteria: (1) bone mineral density (BMD) T value =-2.5; (2) age =65 years old; (3) patients with low back pain symptoms, no obvious relief after more than 3 months of conservative treatment, pain affecting daily life; (4) X-ray examination showed a clear single-segment vertebral body compression fracture; CT examination showed irregular vacuum fissure signs in the vertebral body.

Exclusion criteria

Exclusion criteria: (1) patients with coagulation dysfunction or bleeding tendency; (2) simple thoracolumbar osteoporotic vertebral fractures; (3) patients with severe diseases of the heart, liver, lung, and nervous system who cannot tolerate surgery; (4) long-term use of hormone therapy; (5) malignant tumors of the spine and spinal infection; (6) patients with hypersensitive constitutions and mental disorders.

Design outcomes

Primary

MeasureTime frame
Bone cement leakage rate;

Secondary

MeasureTime frame
Visual Analogue Scale/Score(VAS);Oswestry disability index;anterior vertebral height ratio;kyphotic Cobb angle;cement injection volume;operation time;intraoperative bleeding;

Countries

China

Contacts

Public ContactYunqing Wang

The Second Affiliated Hospital of Xuzhou Medical University

wang.yunqing@163.com+86 13505203997

Outcome results

None listed

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