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Clinical study on the use of fluoroscopy to observe the distribution of bone cement in the prediction of spinal canal leakage during vertebroplasty

Clinical study on the use of fluoroscopy to observe the distribution of bone cement in the prediction of spinal canal leakage during vertebroplasty

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034521
Enrollment
Unknown
Registered
2020-07-08
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-07-13

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

Bone cement real leakage group:Nil
False leakage of bone cement group:Nil

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The middle-aged and old people (over 50 years old or with secondary osteoporosis) who have no obvious inducement or mild violence injury and have slight relief in bed rest and obvious pain during turning over or sitting up; 2. Patients with new vertebral compression fracture diagnosed by imaging examination without any symptoms of nerve compression; 3. The patients whose chest, waist and back pain had no obvious relief after 2 weeks of conservative treatment such as bed rest and oral analgesics, or the patients and their families required early active treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with multiple severe systemic diseases, who have large surgical contraindications or can not tolerate minimally invasive surgery; 2. Patients with spinal fracture caused by tumor and infectious diseases; 3. Patients with vertebral fracture time more than 3 months, conservative treatment of incomplete Union, and vertebral compression more than 2 / 3. 4. Patients with abnormal vertebral development or severe degenerative scoliosis (X-ray film can not clearly show the posterior edge of the vertebral body).

Design outcomes

Primary

MeasureTime frame
Whether the bone cement leaks into the spinal canal;Symptoms of nerve and spinal cord injury;Vertebral height;The injection of bone cement;Height recovery ratio;Bone cement distribution;

Secondary

MeasureTime frame
VAS pain score before surgery;VAS pain score after surgery;Injection pressure of bone cement;

Countries

China

Contacts

Public ContactZhang Hui

Tianjin First Central Hospital

zhclbbyxy@163.com+86 13920350353

Outcome results

None listed

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