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Clinical translational research for a novel verteroplasty instrument and a spinal dynamic stabilization product

Clinical translational research for a novel verteroplasty instrument and a spinal dynamic stabilization product

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021625
Enrollment
Unknown
Registered
2019-03-01
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Spinal fracture, spinal degenerative disease

Interventions

New cement group:a new cement kyphoplasty
PMMA cement group:PMMA cement kyphoplasty
New titanium alloy spinal internal fixation system group:Surgery with a new titanium alloy spinal internal fixation system
Ti6Al4Vspinal internal fixation system group:Surgery with Ti6Al4Vspinal internal fixation system

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with osteoporotic spinal fracture confirmed by clinical and imaging examination need PKP operation; 2. Patients with spinal degenerative diseases need to be treated with spinal screw internal fixation system; 3. There is no contraindication of operation for routine test and examination before operation; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious organs damage; 2. Mental disorders; 3. Pregnant women and lactating women; 4. Patients who are unwilling to restrict their activities and fail to comply with doctor's advice; 5. Those who have participated in other clinical trials within 3 months; 6. The doctor does not think it is suitable for the group.

Design outcomes

Primary

MeasureTime frame
VAS;ODI;Spinal range of motion;vertebral height;Kyphotic angle;Fusion rate;Complication;

Secondary

MeasureTime frame
spondylolisthesis grading;

Countries

China

Contacts

Public ContactYue Zhu

The First Hospital of China Medical University

zhuyuedr@163.com+86 13940227775

Outcome results

None listed

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