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Clinical study for open bone cement augmentation in the treatment of spinal metastasis

Clinical study for open bone cement augmentation in the treatment of spinal metastasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030071
Enrollment
Unknown
Registered
2020-02-22
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

spinal metastases

Interventions

Single arm:bone cement augmentation

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with spinal metastatic tumor, with solitary spinal lesion or with certain responsible vertebrae in multiple-level spinal metastases; 2. Aged over 18 years; 3. life expectancy longer than 6 months; 4. patients with neurological deficits or spinal instability (SINS>6 and <=12); 5. inform consent form signed.

Exclusion criteria

Exclusion criteria: 1. osteoblastic metastasis; 2. Not tolerated with general anesthesia/surgery; 3. Coagulation disorders; 4. Not tolerated with MRI/CT scan during follow-up; 5. Hypersensitive to bone cement; 6. Complicated with psychological disorders that not able to provide informed consent; 7. Complicated with severe diseases that shorten survival or cause chronic pain; 8. Dyscrasia or multi-organ dysfunction; 9. Drug abuse or other medical, psychological or social conditions affect participation or assessing of our trial; 10. Hypersensitive to given drugs in our trial; 11. Any conditions affecting the safety or participation.

Design outcomes

Primary

MeasureTime frame
Tumor Local Control;VAS Score;

Secondary

MeasureTime frame
Overall Survival;Frankel Score;KPS Score;SINS Score;

Countries

China

Contacts

Public ContactYiqun Cao

Fudan University Shanghai Cancer Center

yiqun_fduscc@163.com+86 021 64175590

Outcome results

None listed

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